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美国药典 USP标准品

USP 认证药物成分

概述

鉴于人们日益关注药物成分的质量和稳定性，USP 为活性药物成分(API) 和药物辅料提供严格的认证计划。这项服务向制造厂商、监管机构和客户保证带有醒目的USP 认证标记的原料药和辅料具有稳定的高质量。

什么是USP 药物成分认证？

USP 认证药物

成分标记

USP 药物成份认证计划有助于公司达到最优质量管理实践。USP 专家向原料药厂商提供符合药品生产质量管理规范(GMP) 的审查、文件审核、实验室测试和持续进行的变更报告以及监督服务。

USP 认证标记代表什么？

USP 将USP 认证标记授予那些完全符合USP 认证标准的公司和药物成分：认证标准包括通过药品生产质量管理规范(GMP) 的审查，全面的文件审核以及药物纯度和效力的测试。USP 认证标记可用于经认证成分的外包装及其分析证书，证实药品的质量和完整性。经USP 认证的药物成分也将获颁USP 合格证书–目前市场上质量最高，最全面的认证。

购买经USP 认证成分的药品制造厂商可以确信：

成分的质量在各个批次中保持一致；

成分达到标签或证书上有关特性、效力、纯度和质量的分析说明标准；

成分严格按照国际公认的药品生产质量管理规范(GMP) 对原料药和辅料的规定进行生产；并且

达到可接受污染物限制要求。

什么是认证流程？

审核第一年要求达成四项工作内容，审核期间则视每种成分而有所不同：

1.生产制造和质量控制文件的评估和审核

2.在制造厂商提供的期间内进行药品生产质量管理规范(GMP) 审查

3.全面的实验室测试

4.监督和认证后审核，包括跟踪监控和变更报告

为确保USP 合格证书的完整性，在审核期间每年要执行以下工作内容：

1.评估和审核公司递交的年度报告中包含的文件

2.审查—审核期间需要进行关注于以前风险领域的自我审计。USP 可全权决定进行额外审查

3.对指定批次进行实验室测试

1096702 Carprofen Related Compound A (50 mg) (carbazole)F0F276 1 [86-74-8]

1102974 Cetrimonium Bromide (1 g) F0F316 1 [57-09-0]

1134211 Cladribine Related Compound A (20 mg) (2-methoxy-2’-deoxyadenosine)F0F244 1 [24757-70-8] 1188709 Diclofenac Potassium (200 mg) F0F269 1.000 mg/mg (dr) 1 [15307-81-0]

1224664 Docosyl Ferulate (50 mg) F0E143 0.99 mg/mg (ai) 1 [101927-24-6]

1287358 Gabapentin Related Compound D (20 mg)

((1-(3-oxo-2-aza-spiro[4.5]dec-2-ylmethyl)-cyclohexyl)aceticacid)F0F246 0.99 mg/mg (ai) 1 n/f 1295724 Glyceryl Distearate (500 mg) F0F284 1 [1323-83-7]

1304209 Heptane (1.2 mL/ampule; 3 ampules) F0E211 0.99 mg/mg (ai) 1 [142-82-5]

1347700 Irbesartan (200 mg) F0F293 0.998 mg/mg (ai) 1 [138402-11-6]

1347802 Isobutyl acetate (1.2 mL/ampule; 3 ampules) F0E246 1.00 mg/mg (ai) 1 [110-19-0] 1350104 Isopropyl Acetate (1.2 mL/ampule; 3 ampules) F0E225 1.00 mg/mg (ai) 1 [108-21-4] 1482014 Oxandrolone Related Compound A CIII (20 mg)

(17beta-hydroxy-17alpha-methyl-2-oxa-5alphaandrost-7-en-3-one)F0F137 1.00 mg/mg (ai) 1 n/f 1482036 Oxandrolone Related Compound C CIII (20

mg)(17,17-dimethyl-18-nor-2-oxa-5alpha-androst-13-en-3-one)F0F135 0.99 mg/mg (ai) 1 n/f 1504933 Pentane (1.2 mL/ampule; 3 ampules) F0E196 1.00 mg/mg (ai) 1 [109-66-0]

1544304 Pirbuterol Acetate (200 mg) (AS) F0F256 1 [65652-44-0]

1547302 Polyoxyl 10 Oleyl Ether (1 mL) F0E078 1 [9004-98-2]

1576402 Propyl Acetate (1.2 mL/ampule; 3 ampules) F0E220 1.00 mg/mg (ai) 1 [109-60-4] 1609024 Salicylic Acid Related Compound B (100 mg) (4-hydroxyisophthalic acid)F0F272 0.99 mg/mg (ai) 1 [636-46-4]

1667905 Tizanidine Hydrochloride (200 mg) F0F226 0.997 mg/mg (ai) 1 [64461-82-1]

1672206 Topiramate (200 mg) F0F297 0.996 mg/mg (ai) 1 [97240-79-4]

1672210 Topiramate Related Compound A (25

mg)(2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose)F0F279 1 [20880-92-6]

1042500 L-Arginine (200 mg) G2E280 1.000 mg/mg (dr) 2 G-1 (06/07)G (09/00)[74-79-3]

1081002 Butalbital CIII (200 mg) I0F204 0.999 mg/mg (ai) 2 H0C054 (12/07)G2B077 (07/04)G-2 (06/03)G (05/02)[77-26-9]

1091006 Capreomycin Sulfate (250 mg) G1F191 890 ug/mg (dr) 2 G (11/07)F (06/01)[1405-37-4] 1091221 Captopril Disulfide (100 mg) H0F251 0.99 mg/mg (ai) 2 G1B066 (12/07)G (01/04)[64806-05-9] 1095506 Carbidopa (400 mg) J0F258 0.926 mg/mg (ai) 2 I (09/07)H (10/99)[38821-49-7]

1111103 Chlorhexidine Acetate (500 mg) H0F199 0.997 mg/mg (an) 2 G0E008 (11/07)F0C281

(02/06)[56-95-1]

1140430 Clopidogrel Bisulfate (125 mg) G0F282 0.988 mg/mg (ai) 2 F0E115 (11/07) [120202-66-6] 1185020 Diazepam Related Compound A (25 mg) (2-Methyl-amino-5-chlorobenzophenone)I1F077 1.00 mg/mg (ai) 2 I (12/07)H-1 (11/02)H (04/00)[1022-13-5]

1186000 Diazoxide (200 mg) H0F314 0.999 mg/mg (ai) 2 G1C017 (11/07)G (12/03)[364-98-7] 1205003 Diltiazem Hydrochloride (200 mg) J0F005 0.999 mg/mg (dr) 2 I (11/07) [33286-22-5] 1271733 Fluconazole Related Compound C (10 mg)

(1,1’-(1,3-phenylene)di(1H-1,2,4-triazole))G0F202 0.99 mg/mg (ai) 2 F0D082 (12/07) n/f 1287008 Furosemide (125 mg) K0F188 0.997 mg/mg (dr) 2 J1B131 (10/07)J (10/03)[54-31-9] 1288500 Gemfibrozil (200 mg) H1F285 0.997 mg/mg (ai) 2 H (11/07) [25812-30-0]

1314009 Hydrochlorothiazide (200 mg) J0F070 0.997 mg/mg (ai) 2 I (11/07)H (05/02)[58-93-5] 1329800 Hydroxypropyl Cellulose (200 mg) G0F066 0.999 mg/mg (dr) 2 F-1 (07/07) [9004-64-2] 1336205 Ifosfamide (500 mg) H0F233 1.000 mg/mg (an) 2 G1C371 (12/07)G (03/06)F-1 (11/00)F (02/99)[3778-73-2]

1336806 Imidurea (200 mg) I0F180 2 H (09/07)G (10/99)[39236-46-9]

1342106 Insulin Human (100 mg) I1F270 26.6 USP InsulinHuman Units/mg(ai)2 I0C383 (11/07)H1A031 (07/05)H (11/02)G (04/00)[11061-68-0]

1379106 Megestrol Acetate (500 mg) I1F281 0.999 mg/mg (an) 2 I (10/07)H (05/00)[595-33-5] 1392705 Mesalamine (200 mg) I0F121 1.000 mg/mg (dr) 2 H0C341 (12/07)G1B001 (06/05)G (01/03)F-1 (03/00)[89-57-6]

1436006 Methylprednisolone Acetate (200 mg) I0F082 0.998 mg/mg (dr) 2 H0D148 (10/07)G-2 (05/05)G-1 (02/00)[53-36-1]

1449518 Nabumetone (200 mg) G0F312 0.997 mg/mg (ai) 2 F0C072 (11/07) [42924-53-8]

1454008 Nandrolone CIII (50 mg) G0F291 1.00 mg/mg (ai) 2 F4D144 (10/07)F-3 (04/05)[434-22-0] 1460000 Neostigmine Methylsulfate (200 mg) J0F167 1.000 (dr) 2 I (11/07)H (07/00)[51-60-5] 1470004 Norethindrone Acetate (100 mg) K0F227 0.996 mg/mg (ai) 2 J1E102 (11/07)J0B072 (09/06)I (04/03)H (06/99)[51-98-9]

1478582 Ondansetron Hydrochloride (300 mg) G1F249 0.993 mg/mg (an) 2 G0D154 (11/07)F0C222 (05/05)[103639-04-9]

1478593 Ondansetron Related Compound A (50

mg)(3[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one

hydrochloride)F1F240 2 F0C191 (10/07) [119812-29-2]

1500273 Paroxetine Related Compound F (10 mg)

(trans(-)-1-Methyl-3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine)G0F221 1.00 mg/mg (ai) 2 F0D237 n/f

1501108 Penicillamine Disulfide (200 mg) I0F234 1.00 mg/mg (dr) 2,3 H (10/07)G (07/00)[20902-45-8] 1554670 Praziquantel Related Compound C (50 mg)

(2-(Nformylhexahydrohippuroyl)-1,2,3,4-tetrahydroisoquinolin-1-one)G0F288 1.00 mg/mg (dr) 2 F-2 (08/07)F-1 (06/00)n/f

1606503 Rutin (100 mg) G1F308 2 G0C355 (11/07)F (09/05)[153-18-4]

1000601 Acebutolol Hydrochloride (125 mg) F-1 [34381-68-5]

1001003 Acenocoumarol (200 mg) G0D300 F (10/05) [152-72-7]

1001502 Acepromazine Maleate (250 mg) F-2 F-1 (05/02) [3598-37-6]

1002505 Acesulfame Potassium (200 mg) F0C136 [55589-62-3]

1003009 Acetaminophen (400 mg) J2C423 0.996 mg/mg (dr) J-1 (04/06)J (05/02)I (05/99)[103-90-2] 1004001 Acetanilide Melting Point Standard (500 mg)(Approximately 114 degrees)M0A029 L (06/04)K (02/00)[103-84-4]

1005004 Acetazolamide (2 g) J1E041 0.997 mg/mg (dr) J (02/06) [59-66-5]

1005706 Glacial Acetic Acid (1.5 mL/ampule; 3 ampules)(AS)F0D002 99.9% (ai) [64-19-7] 1006007 Acetohexamide (250 mg) H G-1 (06/99) [968-81-0]

1006506 Acetohydroxamic Acid (200 mg) F-1 F (03/03) [546-88-3]

1006801 Acetone (1.5 mL/ampule; 3 ampules) F0D028 0.997 mg/mg (ai) [67-64-1]

1007000 Acetophenazine Maleate (200 mg) F-1 [5714-00-1]

1008501 Acetylcholine Chloride (200 mg) H0F091 1.000 mg/mg (dr) G (03/07) [60-31-1]

1009005 Acetylcysteine (200 mg) H1B169 H (01/04) [616-91-1]

1009901 Acetyltributyl Citrate (500 mg) G0C120 F (05/04) [77-90-7]

1009923 Acetyltriethyl Citrate (500 mg) G0E085 F-1 (01/07)F (05/02)[77-89-4]

1011007 Acitretin (200 mg) F0E266 0.998 mg/mg (ai) [55079-83-9]

1011018 Acitretin Related Compound A (20

mg)((2Z,4E,6E,8E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic acid) F0E264 [69427-46-9]

1011029 Acitretin Related Compound B (20 mg)

(ethyl(all-E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoate)

F0E265 [54350-48-0]

1012065 Acyclovir (300 mg) J0C149 I (06/04) [59277-89-3]

1012076 Acyclovir Related Compound A (50 mg) (AS)

(2-[(2-amino-6-oxo-1,6-dihydro-9H-purin-9-yl)-methoxy]ethyl acetate) F0F010 n/f

1012134 Ademetionine Disulfate Tosylate (500 mg) F0D073 [97540-22-2]

1012101 Adenine (200 mg) G2D279 1.000 mg/mg (dr) G-1 (12/05) G (06/00) [73-24-5]

1012123 Adenosine (200 mg) G0C295 F1B058 (01/05) F (04/03) [58-61-7]

1012190 Adipic Acid (100 mg) F0D318 [124-04-9]

1012145 Agigenin (25 mg) F n/f

1012203 Agnuside (25 mg) F0D397 0.88 mg/mg (ai) [11027-63-7]

1012495 Beta Alanine (100 mg) F0F111 1.00 mg/mg (ai) [107-95-9]

1012509 L-Alanine (200 mg) G0E002 1.00 mg/mg (ai) F-2 (08/06) F-1 (04/01) [56-41-7]

1012553 Albendazole (200 mg) H0E240 0.996 mg/mg (dr) G (10/06)F-1 (01/00)[54965-21-8] 1012600 Albuterol (200 mg) I H (12/00) [18559-94-9]

1012633 Albuterol Sulfate (200 mg) J I (04/00) [51022-70-9]

1012757 Alclometasone Dipropionate (300 mg) I0C302 0.992 mg/mg (ai) H (09/07)G (01/00)[66734-13-2] 1012768 Alcohol (1.2 mL/ampule; 5 ampules) F0D030 [64-17-5]

1012772 Dehydrated Alcohol (1.2 mL/ampule; 5 ampules)F0D031 [64-17-5]

1012699 Alcohol Determination–Acetonitrile (5 mL/ampule;5 ampules)F0C419 2% v/v (ai) n/f 1012688 Alcohol Determination–Alcohol (5 mL/ampule;5 ampules)F0C399 1.96% v/v (ai) n/f 1012780 Alendronate Sodium (200 mg) G0D288 0.834 mg/mg (ai) F0B315 (02/06) [121268-17-5] 1012906 Alfentanil Hydrochloride CII (500 mg) F0B016 [70879-28-6]

1012939 Allantoin (200 mg) F0C169 [97-59-6]

1012950 Alliin (25 mg) F [556-27-4]

1013002 Allopurinol (250 mg) J0C186 I-1 (01/05)I (07/02)[315-30-0]

1013024 Allopurinol Related Compound A (50 mg) (3-Amino-4-carboxamidopyrazole Hemisulfate)G F-3 (05/02)F-2 (04/99)n/f

1013057 S-Allyl-L-Cysteine (25 mg) F n/f

1014005 Alphaprodine Hydrochloride CII (250 mg) F [561-78-4]

1015008 Alprazolam CIV (200 mg) H1C133 H (06/05) [28981-97-7]

1016000 Alprostadil (25 mg) H1F110 0.991 mg/mg (ai) H (06/07) [745-65-3]

1017105 Altretamine (500 mg) F [645-05-6]

1017502 Dried Aluminum Hydroxide Gel (200 mg) F2B120 F-1 (01/04) [21645-51-2]

1017364 Aluminum Sulfate (2 g) (AS) F0D342 55.3 % (ai) [17927-65-0]

1018505 Amantadine Hydrochloride (200 mg) H1D207 0.998 mg/mg (ai) H (02/06)G (04/01)[665-66-7] 1019202 Amcinonide (200 mg) H0D346 0.995 mg/mg (ai) G0B260 (06/06)F-1 (03/04)[51022-69-6] 1019417 Amifostine Disulfide (25 mg) F0C152 [112901-68-5]

1019508 Amikacin (300 mg) J0E226 0.981 mg/mg (an) I (10/06)H (08/00)[37517-28-5]

1019701 Amiloride Hydrochloride (500 mg) H [17440-83-4]

1019712 Amiloride Related Compound A (30 mg) (AS)(Methyl

3,5-diamino-6-chloropyrazine-2-carboxylate)F0E287 [1458-01-1]

1019756 Aminobenzoate Potassium (200 mg) F-1 F (06/01) [138-84-1]

1019767 Aminobenzoate Sodium (200 mg) F [55-06-6]

1019803 Aminobenzoic Acid (200 mg) (p-aminobenzoic acid)H1C083 H (10/04)G (10/00)[150-13-0] 1020008 Aminobutanol (500 mg) G-1 G (06/99) [96-20-8]

1021000 Aminocaproic Acid (200 mg) G0D101 0.997 mg/mg (dr) F-4 (09/05) [60-32-2]

1022808 2-Amino-5-chlorobenzophenone (25 mg) J0F197 1.00 mg/mg (ai) I (09/07)H-1 (01/03)[719-59-5] 1025205 Aminoglutethimide (200 mg) F [125-84-8]

1025307 m-Aminoglutethimide (100 mg) G F (05/01) n/f

1025351 Aminohippuric Acid (200 mg) F-1 [61-78-9]

1025806 2-[3-Amino-5-(n-methylacetamido)-2,4,6-triiodobenzamido]-2-deoxy-d-glucose (25 mg)F

n/f

1025908 Aminopentamide Sulfate (200 mg) F0B273 [60-46-8]

1021204 4-Aminophenol (100 mg) F0F099 0.99 mg/mg (ai) [123-30-8]

1026004 m-Aminophenol (300 mg) F [591-27-5]

1026401 Aminosalicylic Acid (125 mg) F-1 F (03/99) [65-49-6]

1026605 3-Amino-2,4,6-triiodobenzoic Acid (50 mg) G [3119-15-1]

1027007 5-Amino-2,4,6-triiodo-N-methylisophthalamic Acid (50 mg)F-1 [2280-89-9]

1027302 Amiodarone Hydrochloride (200 mg) F0D257 0.995 mg/mg (ai) [19774-82-4]

1028000 Amitraz (200 mg) F0C042 (08/07) [33089-61-1]

1029002 Amitriptyline Hydrochloride (200 mg) J0A004 I (03/03) [549-18-8]

1029501 Amlodipine Besylate (350 mg) G0F133 0.997 mg/mg (an) F0D167 (06/07) [111470-99-6] 1029909 Ammonio Methacrylate Copolymer Type A (100 mg)F-1 F (06/01) [33434-24-1]

1029910 Ammonio Methacrylate Copolymer Type B (100 mg) F2C082 F-1 (06/05)F (05/00)[33434-24-1] 1029942 Ammonium Carbonate (2 g) (AS) F0D102 33.3% NH3 (ai) [8000-73-5]

1029953 Ammonium Chloride (200 mg) F0C134 [12125-02-9]

1029986 Ammonium Phosphate Dibasic (1 g) (AS) F0D104 100.0 % (ai) [7783-28-0]

1030001 Amobarbital CII (200 mg) F-2 [57-43-2]

1031004 Amodiaquine Hydrochloride (500 mg) H0B238 G-1 (04/03) [6398-98-7]

1031401 Amoxapine (200 mg) G1D375 1.000 mg/mg (dr) G (03/07) F-1 (04/02)[14028-44-5] 1031503 Amoxicillin (200 mg) J0C043 I (07/04) [61336-70-7]

1032007 Amphotericin B (125 mg) J3C246 1009 ug/mg (dr) J-2 (01/05)J-1 (07/02)[1397-89-3] 1033000 Ampicillin (200 mg) K0D139 998 ug/mg (dr) J-1 (05/07)J (12/01)[69-53-4]

1033203 Ampicillin Sodium (125 mg) G-1 G (10/99) [69-52-3]

1033407 Ampicillin Trihydrate (200 mg) G1D147 G (08/05) [7177-48-2]

1034002 Amprolium (200 mg) G0C317 0.991 mg/mg (dr) F-1 (04/05)F (04/02)[121-25-5]

1034308 Amrinone (500 mg) G [60719-84-8]

1034320 Amrinone Related Compound A (100 mg) (5-carboxamide[3,4’-bipyridin]-6(1H)-one) F [62749-46-6]

1034341 Amrinone Related Compound B (100 mg)

(N-(1,6-dihydro-6-oxo-(3,4’-bipyridine)-5-yl)-2-hydroxypropanamide) F-1 F (03/00) n/f 1034363 Amrinone Related Compound C (50 mg)

(1,6-dihydro-6-oxo-(3,4’-bipyridine)-5-carbonitrile) F-1 F (05/00) n/f

1034909 Anecortave Acetate (200 mg) F0E298 0.997 mg/mg (ai) [7753-60-8]

1034910 Anecortave Acetate Related Compound A (20 mg) (9(11)-dehydrocortisol) F0E299 [10184-70-0] 1035005 Anethole (2 mL) (AS) F0E023 [4180-23-8]

1036008 Anileridine Hydrochloride CII (250 mg) F [126-12-5]

1036507 3-Anilino-2-(3,4,5-trimethoxybenzyl) acrylonitrile (25 mg) (AS) G2D383 G-1 (04/06) [30078-48-9]

1037011 Anisole (1.2 mL/ampule; 3 ampules) F0E216 1.00 mg/mg (ai) [100-66-3]

1038003 Antazoline Phosphate (200 mg) H G-1 (04/02) [154-68-7]

1039006 Anthralin (200 mg) I0B221 H (11/02) [1143-38-0]

1040005 Antipyrine (200 mg) G1F162 0.999 mg/mg (ai) G (08/07) F-4 (09/01) [60-80-0]

1040708 Apigenin-7-glucoside (30 mg) F n/f

1041008 Apomorphine Hydrochloride (250 mg) H G (01/03) [41372-20-7]

1041609 Apraclonidine Hydrochloride (100 mg) H0B112 (12/07) G (06/03) [73218-79-8]

1042000 Aprobarbital CIII (200 mg) (AS) DISCONTINUED F-1 (02/07) [77-02-1]

1042102 L-Arabinitol (500 mg) F0E311 1.00 mg/mg (an) [7643-75-6]

1042500 L-Arginine (200 mg) G2E280 1.000 mg/mg (dr) 2 G-1 (06/07) G (09/00)[74-79-3] 1042601 Arginine Hydrochloride (125 mg) G0B060 F-1 (05/03) [1119-34-2]

1042703 Arsanilic Acid (25 mg) F [98-50-0]

1043003 Ascorbic Acid (1 g) (Vitamin C) Q0B012 P (04/03) [50-81-7]

1043105 Ascorbyl Palmitate (2 g) (AS) F0D326 0.988 mg/mg (ai) [137-66-6]

1043502 Asparagine Anhydrous (200 mg) F0E013 1.00 mg/mg (dr) [70-47-3]

1043513 Asparagine Monohydrate (200 mg) F0E012 1.00 mg/mg (ai) [5794-13-8]

1043706 Aspartame (200 mg) H1B125 H (05/03) [22839-47-0]

1043750 Aspartame Acesulfame (200 mg) F0C137 [106372-55-8]

1043728 Aspartame Related Compound A (25 mg) (5-Benzyl-3,6-dioxo-2-piperazineacetic Acid) I0D208 0.99 mg/mg (ai) H (11/05) G-1 (10/99) [5262-10-2]

1043819 Aspartic Acid (100 mg) F0B087 [6899-03-2]

1044006 Aspirin (500 mg) H G-1 (11/02) [50-78-2]

1044301 Astemizole (200 mg) F [68844-77-9]

1044403 Atenolol (200 mg) I0F032 0.999 mg/mg (dr) H1C320 (04/07) H (01/05) G (08/01)[29122-68-7]

1044651 Atovaquone (200 mg) F0B190 [95233-18-4]

1044662 Atovaquone Related Compound A (25 mg)

(cis-2-[4-(4-chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthoquinone) F0B188 n/f

1044800 Atracurium Besylate (100 mg) F0B143 [64228-81-5]

1045009 Atropine Sulfate (500 mg) M0B098 L-2 (04/03) L-1 (06/02)L (10/00)[5908-99-6]

1045337 Avobenzone (500 mg) G1E109 0.996 mg/mg (dr) G0B280 (09/06)F (09/03)[70356-09-1] 1045508 Aurothioglucose (100 mg) I0E208 H0B224 (08/07)G (10/03)F (12/01)[12192-57-3]

1045600 Azaerythromycin A (100 mg) (9-Deoxo-9a-aza-9a-homoerythromycin A) G1D368 G (05/06)F-1 (02/02)F (02/99)[76801-85-9]

1045756 Azaperone (200 mg) F1F183 0.995 mg/mg (ai) F (09/07) [1649-18-9]

1045803 Azatadine Maleate (200 mg) G0B300 F-1 (04/04) F (06/00)[3978-86-7]

1046001 Azathioprine (200 mg) H G-1 (02/00) [446-86-6]

1046056 Azithromycin (100 mg) H0C212 G (11/04)F (06/00)[117772-70-0]

1046103 Azlocillin Sodium (200 mg) F [37091-65-9]

1046147 Azo-aminoglutethimide (100 mg) F n/f

1046205 Aztreonam (200 mg) G0C077 F-1 (03/04) [78110-38-0]

1046307 Aztreonam E-Isomer (50 mg) F1D056 F (04/05) n/f

1046409 Open Ring Aztreonam (25 mg) G0D071 F (12/04) [87500-74-1]

1047300 Bacampicillin Hydrochloride (200 mg) G0B053 F (11/02) [37661-08-8]

1047503 Bacitracin (1 g) (Susceptibility disk standard) G1C254 G (07/04) [1405-87-4]

1048007 Bacitracin Zinc (200 mg) N1E200 75.1 USP Bacitracin Units/mg (dr)N0A024 (12/06)M-1 (11/02)M (02/00)[1405-89-6]

1048200 Baclofen (500 mg) I [1134-47-0]

1048222 Baclofen Related Compound A (50 mg) (4-(4-Chlorophenyl)-2-pyrrolidinone)I0F047 1.00 mg/mg (ai) H1C289 (06/07)H (11/04)n/f

1048506 Beclomethasone Dipropionate (200 mg) L0D312 0.992 mg/mg (dr) K (02/06)J (12/00)[5534-09-8] 1048619 Benazepril Hydrochloride (125 mg) G0E079 0.996 mg/mg (dr) F0C250 (03/06) [86541-74-4] 1048620 Benazepril Related Compound A (15 mg)

((3R)-3-[[(1R)-1-(ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzaz epine-1-acetic acid, monohydrochloride) F0C252 n/f

1048630 Benazepril Related Compound B (15 mg)

((3S)-3-[[(1R)-1-(ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzaz epine-1-acetic acid, monohydrochloride) F1E156 0.99 mg/mg (ai) F0C256 (02/07) n/f

1048641 Benazepril Related Compound C (50 mg)

((3S)-3-[[(1S)-1-carboxy-3-phenylpropyl]amino-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine]-1-a cetic acid) F0C425 1.00 mg/mg (ai) [86541-78-8]

1048652 Benazepril Related Compound D (15 mg)

(3-(1-Ethoxycarbonyl-3-cyclohexyl-(1S)-propyl)amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benza zepine-1-acetic acid monohydrochloride) F0F149 0.99 mg/mg (ai) n/f

1048674 Benazepril Related Compound F (15 mg)

(3-Amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid, tert-butyl ester)

F0F150 1.00 mg/mg (ai) [109010-60-8]

1048685 Benazepril Related Compound G (15 mg)

((3-(1-Ethoxycarbonyl-3-phenyl-(1S)-propyl)amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazep

ine)-1-acetic acid, ethyl ester) F0F155 1.00 mg/mg (ai) [103129-58-4]

1049000 Bendroflumethiazide (200 mg) H0C402 0.994 mg/mg (ai) G-1 (06/05) [73-48-3]

1050009 Benoxinate Hydrochloride (200 mg) F-2 F-1 (10/99) [5987-82-6]

1051001 Benzalkonium Chloride (5 mL of approx. 10% aqueous solution) L0D209 Approx. 10% (w/v) K0B151 (10/06)J (06/03)[8001-54-5]

1051500 Benzethonium Chloride (500 mg) F0E104 [121-54-0]

1054000 Benzocaine (500 mg) J0C130 I (12/04) [94-09-7]

1055002 Benzoic Acid (300 mg) G0D223 1.000 mg/mg (dr) F6B173 (02/07)F-5 (03/04)F-4 (07/01)[65-85-0] 1056005 Benzonatate (1 g) I0B003 H (01/03) [104-31-4]

1056504 1,4-Benzoquinone (200 mg) G1B145 G (01/04)F-1 (11/01)F (09/00)[106-51-4]

1057507 Benzothiadiazine Related Compound A (100 mg) (4-Amino-6-chloro-1,3-benzenedisulfonamide) I0F027 1.00 mg/mg (dr) H0B069 (02/07)G-4 (03/03)[121-30-2]

1059003 Benzphetamine Hydrochloride CIII (200 mg)(AS)F2C272 F-1 (10/05) [5411-22-3]

1060002 Benzthiazide (200 mg) F [91-33-8]

1061005 Benztropine Mesylate (200 mg) I0C038 H (09/04) [132-17-2]

1061901 Benzyl Alcohol (500 mg/ampule) G1E155 1.00 mg/mg (ai) G0B306 (04/07)F0B106

(10/03)[100-51-6]

1062008 Benzyl Benzoate (5 g) J0C060 I (05/04) [120-51-4]

1064003 1-Benzyl-3-methyl-5-aminopyrazole Hydrochloride (25 mg)F-1 n/f

1065006 Bephenium Hydroxynaphthoate (500 mg) F [3818-50-6]

1065210 Berberine Chloride (50 mg) F0E185 0.81 mg/mg (ai) [633-65-8]

1065618 Betahistine Hydrochloride (200 mg) F0C105 [5579-84-0]

1065709 Betaine Hydrochloride (200 mg) G0F176 F-1 (09/07) F (11/02)[590-46-5]

1066009 Betamethasone (200 mg) K2C204 K-1 (10/04)K (11/02)[378-44-9]

1067001 Betamethasone Acetate (500 mg) J0B079 I (08/03) [987-24-6]

1067307 Betamethasone Benzoate (200 mg) F-1 [22298-29-9]

1067704 Betamethasone Dipropionate (125 mg) K0C229 J (04/04)I (03/99)[5593-20-4]

1068004 Betamethasone Sodium Phosphate (500 mg) K0C358 0.993 mg/mg (an) J0B043 (06/05)I-1 (02/03)I (01/01)[151-73-5]

1069007 Betamethasone Valerate (200 mg) K0C330 0.997 mg/mg (ai) J (07/05)I (05/00)[2152-44-5] 1069018 Betamethasone Valerate Related Compound A (50 mg) (Betamethasone 21-valerate) (AS) F0F229 [2240-28-0]

1069903 Betaxolol Hydrochloride (200 mg) G F-1 (06/00) [63659-19-8]

1070006 Betazole Hydrochloride (200 mg) H [138-92-1]

1071009 Bethanechol Chloride (200 mg) H0E304 0.998 mg/mg (dr) G1D088 (05/07) G (03/05) F-3 (07/01) [590-63-6]

1071202 Bicalutamide (200 mg) F0E321 0.999 mg/mg (ai) [90357-06-5]

1071213 Bicalutamide Related Compound A (25 mg)

(N-[4-cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfinyl]-2-hydroxy-2-methyl-propa namide) F0E322 n/f

1071304 Bile Salts (10 g) I0C003 H-1 (05/04)H (05/99)[145-42-6]

1071439 Positive Bioreaction (3 strips; 10 cm x 1 cm) F0D014 n/f

1071508 Biotin (200 mg) I0D114 0.993 mg/mg (ai) H1B019 (11/05)H (04/03)[58-85-5]

1072001 Biperiden (200 mg) F2B080 F-1 (02/04) [514-65-8]

1073004 Biperiden Hydrochloride (200 mg) G0E182 1.000 mg/mg (ai) F-3 (08/06)F-2 (06/99)[1235-82-1] 1074007 Bisacodyl (125 mg) I1B162 I (01/04)H-1 (02/99)[603-50-9]

1074700 2,5-Bis(D-arabino-1,2,3,4-tetrahydroxybutyl)pyrazine (25 mg) F n/f

1075203 Bis(2-ethylhexyl)maleate (2 mL) G0E308 0.95 mg/mg (ai) F-2 (08/07) F-1 (01/01)[142-16-5] 1075509 p-Bis(di-n-propyl)carbamylbenzenesulfonamide (50 mg) F n/f

1075531 Bismuth Citrate (100 mg) F [813-93-4]

1075600 Bismuth Subcarbonate (1 g) (AS) F0D324 98.4% (dr) [5892-10-4]

1075622 Bismuth Subgallate (2 g) (AS) F0D323 54.2% Bi2O3 (dr) [22650-86-8]

1075644 Bismuth Subnitrate (1.5 g) (AS) F0D388 81.7% Bi2O3 (dr) [1304-85-4]

1075553 Bismuth Subsalicylate (100 mg) F1C394 F (08/05) [14882-18-9]

1075677 Bisoctrizole (200 mg) F0F222 0.998 mg/mg (ai) [103597-45-1]

1075688 Bisoctrizole Related Compound A (25 mg)

(2-(2H-Benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol) F0F225 0.99 mg/mg (ai)

[3147-75-9]

1075699 Bisoctrizole Resolution Mixture (50 mg) F0F239 n/f

1075757 Bisoprolol Fumarate (200 mg) G0D316 0.997 mg/mg (dr) F0B038 (08/05) [104344-23-2] 1076206 Powdered Black Cohosh Extract (1.5 g) F0D086 [84776-26-1]

1076308 Bleomycin Sulfate (15 mg) J0B213 I (01/04) [9041-93-4]

1076341 Boric Acid (1 g) (AS) F0D036 100.0% (dr) [10043-35-3]

1076352 Bretylium Tosylate (200 mg) F-1 [61-75-6]

1076363 Brinzolamide (200 mg) F0C034 [138890-62-7]

1076374 Brinzolamide Related Compound A (50 mg)

((S)-(-)-4-ethylamino-2,3-dihydro-2-(3-methoxypropyl)-4H-thieno-[3,2,e]-thiazine-6-sulfonami de-1,1-dioxide) F0C033 n/f

1076385 Brinzolamide Related Compound B (50 mg)

((R)-4-amino-2,3-dihydro-2-(3-methoxypropyl)-4H-thieno-[3,2,e]-thiazine-6-sulfonamide-1,1-di oxideethanedioate) F0C035 n/f

1076465 Bromazepam CIV (100 mg) (AS) F0F064 [1812-30-2]

1076501 Bromocriptine Mesylate (150 mg) J0E206 0.997 mg/mg (dr) I1C197 (08/07)I

(09/04)[22260-51-1]

1077005 Bromodiphenhydramine Hydrochlor ide (200 mg) F-1 [1808-12-4]

1077708 8-Bromotheophylline (400 mg) G F (07/02) [10381-75-6]

1078008 Brompheniramine Maleate (125 mg) I1A036 I (01/03)H-1 (04/99)[980-71-2]

1078201 Budesonide (200 mg) F0E302 0.997 mg/mg (ai) [51333-22-3]

1078303 Bumetanide (250 mg) I0C111 H0B030 (05/04)G (03/03)[28395-03-1]

1078325 Bumetanide Related Compound A (10 mg) (3-Amino-4-phenoxy-5-sulfamoylbenzoic Acid) G0F031 0.99 mg/mg (ai) F-2 (03/07)F-1 (05/00)n/f

1078336 Bumetanide Related Compound B (25 mg) (3-Nitro-4-phenoxy-5-sulfamoylbenzoic Acid) F-2 F-1 (01/03) [28328-53-2]

1078507 Bupivacaine Hydrochloride (1 g) H1E255 0.945 mg/mg (ai) H (05/07) G-2 (03/03)G-1

(08/02)[14252-80-3]

1078518 Bupivacaine Related Compound A (50 mg)

(6-(butylamino)-N-(2,6-dimethylphenyl)hexanamide)(AS) F0F154 n/f

1078529 Bupivacaine Related Compound B (50 mg)

((2RS)-N-(2,6-dimethylphenyl)piperidine-2-carboxamide)(AS) F0F156 [15883-20-2]

1078700 Buprenorphine Hydrochloride CIII (50 mg) G0E026 0.995 mg/mg (ai) F-1 (03/06) F

(02/99)[53152-21-9]

1078711 Buprenorphine Related Compound A CII (50 mg)

(21-[3-(1-propenyl)]-7alpha-[(S)-1-hydroxy-1,2,2-trimethylpropyl]-6,14-endo-ethano-6,7,8,14-tetrahydrooripavine) F1C076 F (04/04) n/f

1078733 Bupropion Hydrochloride (200 mg) G0E048 0.998 mg/mg (ai) F0C123 (02/06) [31677-93-7] 1078744 Bupropion Hydrochloride Related Compound A (15 mg)

(2-(tert-butylamino)-4’-chloropropiophenone hydrochloride)F0E082 n/f

1078755 Bupropion Hydrochloride Related Compound B (15 mg)

(2-(tert-butylamino)-3’-bromopropiophenone hydrochloride) F0E011 n/f

1078766 Bupropion Hydrochloride Related Compound C (40 mg)

(1-(3-chlorophenyl)-2-hydroxy-1-propanone) F0D293 (11/07) n/f

1078799 Bupropion Hydrochloride Related Compound F (30 mg)

(1-(3-chlorophenyl)-1-hydroxy-2-propanone) F0E076 (11/07) n/f

1078802 Buspirone Hydrochloride (200 mg) H0B301 G (05/05) [33386-08-2]

1079000 Butabarbital CIII (200 mg) H0C007 G (03/04) [125-40-6]

1080000 Butacaine Sulfate (600 mg) F [149-15-5]

1081002 Butalbital CIII (200 mg) I0F204 0.999 mg/mg (ai) 2 H0C054 (12/07)G2B077 (07/04)G-2 (06/03)G (05/02)[77-26-9]

1081501 Butamben (200 mg) G0F059 1.000 mg/mg (dr) F (01/07) [94-25-7]

1081807 1-Butanol (1.2 mL/ampule; 3 ampules) F0E244 1.00 mg/mg (ai) [71-36-3]

1081829 2-Butanol (1.2 mL/ampule; 3 ampules) F0E213 1.00 mg/mg (ai) [78-92-2]

1082300 Butoconazole Nitrate (200 mg) F1B097 F (03/03) [64872-77-1]

1082504 Butorphanol Tartrate CIV (500 mg) J I (06/00) [58786-99-5]

1082606 Butyl Acetate (1.2 mL/ampule; 3 ampules) F0E171 1.00 mg/mg (ai) [123-86-4]

1082708 Butylated Hydroxytoluene (500 mg) (AS) F0D122 >99.0% (ai) [128-37-0]

1082800 Monotertiary-butyl-p-benzoquinone (100 mg) (FCC) F [3602-55-9]

1082901 Butyl 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoate (25 mg) F-1 n/f

1083008 2-tert-Butyl-4-hydroxyanisole (200 mg) L1E348 0.996 mg/mg (ai) L0C028 (03/07) K

(09/03)[88-32-4]

1083100 3-tert-Butyl-4-hydroxyanisole (200 mg) L0E259 0.997 mg/mg (ai) K0C239(02/07)J (03/05)I-1 (09/01)[121-00-6]

1083303 tert-Butylmethyl ether (1.2 mL/ampule; 3 ampules) F0E192 1.00 mg/mg (ai) [1634-04-4] 1084000 Butylparaben (200 mg) I0C139 H-1 (03/04)H (09/01)[94-26-8]

1085003 Caffeine (200 mg) J1D241 0.998 mg/mg (ai) J (02/06)I (06/02)[58-08-2]

1086006 Caffeine Melting Point Standard (1 g) (Approximately 236 degrees) K0D372 J0B204 (11/06)I (03/04)[58-08-2]

1086108 Calcifediol (75 mg) G1E064 0.996 mg/mg (ai) (as monohydrate) G (07/06) [63283-36-3] 1086301 Calcitriol (10 mg) G0F104 0.996 mg/mg (ai) F0E062 (09/07) [32222-06-3]

1086312 Calcitriol Solution (5 mL) F0D330 0.974 ug/mL n/f

1086334 Calcium Acetate (1 g) (AS) F0D156 100.0% (an) [62-54-4]

1086356 Calcium Ascorbate (200 mg) F-1 F (08/01) [5743-28-2]

1086403 Calcium Carbonate (1 g) (AS) F0D099 99.1% (dr) [471-34-1]

1086436 Calcium Chloride (1 g) (AS) F0D153 101.9% (ai) [10035-04-8]

1086800 Calcium Gluceptate (200 mg) F-1 F (09/00) [29039-00-7]

1086855 Calcium Hydroxide (1 g) (AS) F0D168 98.1% (ai) [1305-62-0]

1086888 Calcium Lactate (1 g) F0D227 [63690-56-2]

1086902 Calcium Lactobionate (200 mg) G0B138 F-1 (01/04)F (11/01)[110638-68-1]

1086935 Calcium Levulinate (1 g) (AS) F0E142 98.6% (dr) [5743-49-7]

1087009 Calcium Pantothenate (200 mg) (Vitamin B5) O0C331 0.990 mg/mg (dr) N-1 (06/05)N

(06/00)[137-08-6]

1087031 Tribasic Calcium Phosphate (1 g) (AS) F0D394 37.2 % Ca (ai) [12167-74-7]

1087202 Calcium Saccharate (200 mg) F [5793-89-5]

1087359 Calcium Stearate (2 g) (AS) F0D255 9.8% CaO (ai) [1592-23-0]

1087406 Calcium Sulfate (1 g) (AS) F0D236 100.0% (dr) [10101-41-4]

1087508 Camphor (1 g) F0F030 0.990 mg/mg (ai) [464-49-3]

1087701 Candelilla Wax (250 mg) F0D123 [8006-44-8]

1088001 Candicidin (200 mg) F [1403-17-4]

1089004 Cannabidiol CI (25 mg) (AS) F-2 [13956-29-1]

1091006 Capreomycin Sulfate (250 mg) G1F191 890 ug/mg (dr) 2 G (11/07)F (06/01)[1405-37-4] 1091040 Caprylic Acid (300 mg) F0D378 [124-07-2]

1091505 Caprylocaproyl Polyoxylglycerides (200 mg) F0C312 n/f

1091108 Capsaicin (100 mg) G2D136 0.985 mg/mg (dr) G-1 (07/05)G (03/02)F-1 (06/00)F

(03/99)[404-86-4]

1091200 Captopril (200 mg) H [62571-86-2]

1091221 Captopril Disulfide (100 mg) H0F251 0.99 mg/mg (ai) 2 G1B066 (12/07)G (01/04)[64806-05-9] 1092009 Carbachol (200 mg) G1E010 1.000 mg/mg (dr) G (07/06) [51-83-2]

1093001 Carbamazepine (100 mg) K0E209 0.999 mg/mg (ai) J (11/06)I-1 (02/00)[298-46-4] 1093205 Carbarsone (200 mg) F [121-59-5]

1093500 Carbenicillin Indanyl Sodium (300 mg) G [26605-69-6]

1094004 Carbenicillin Monosodium Monohydrate (200 mg) G-2 (09/07) n/f

1095506 Carbidopa (400 mg) J0F258 0.926 mg/mg (ai) 2 I (09/07) H (10/99)[38821-49-7] 1095517 Carbidopa Related Compound A (25 mg) (3-OMethylcarbidopa) H1F245 0.96 mg/mg (ai) H0B121 (09/07)G (04/03)n/f

1096000 Carbinoxamine Maleate (200 mg) H G-1 (11/02) [3505-38-2]

1096407 Carboplatin (100 mg) H0C240 G (07/04)F (03/00)[41575-94-4]

1096509 Carboprost Tromethamine (25 mg) F-1 F (02/01) [58551-69-2]

1096531 Carboxymethylcellulose Calcium (1.5 g) (AS) F0D336 [9050-04-8]

1096553 Carboxymethylcellulose Sodium (1.5 g) F0D357 [9004-32-4]

1096600 Carisoprodol (1 g) G F-2 (05/02) [78-44-4]

1096699 Carprofen (200 mg) (AS) F0D335 [53716-49-7]

1096702 Carprofen Related Compound A (50 mg) (carbazole) F0F276 1 [86-74-8]

1096757 Carteolol Hydrochloride (200 mg) F-1 (12/07)F (11/00)[51781-21-6]

1096779 Casticin (25 mg) F0D358 0.99 mg/mg (ai) [479-91-4]

1096804 Cathinone Hydrochloride CI (50 mg) (alpha-Aminopropiophenone Hydrochloride) I [76333-53-4]

1096906 Cefaclor (400 mg) I0E145 0.994 mg/mg HPLC (an) 1.000 mg/mg UV (an)H (11/06) [70356-03-5]

1096917 Cefaclor, Delta-3-Isomer (30 mg) G (12/07)F-1 (02/00)n/f

1097104 Cefadroxil (125 mg) I1B319 935 ug/mg (ai) I (01/05)H (04/99)[66592-87-8]

1097308 Cefamandole Lithium (200 mg) H n/f

1097400 Cefamandole Nafate (200 mg) H [42540-40-9]

1097501 Cefamandole Sodium (250 mg) F (12/07) [30034-03-8]

1097603 Cefazolin (400 mg) L0C345 K (04/05)J (06/00)[25953-19-9]

1097636 Cefepime Hydrochloride (500 mg) G0D116 860 ug/mg (an) F0C063 (06/05) [123171-59-5] 1097647 Cefepime Hydrochloride System Suitability (25 mg) F0C095 n/f

1097658 Cefixime (500 mg) F [79350-37-1]

1097771 Cefmenoxime Hydrochloride (350 mg) F [75738-58-8]

1097782 Cefmetazole (200 mg) G0E260 0.988 mg/mg (ai) F-1 (09/06)F (04/02)[56796-20-4] 1097750 Cefonicid Sodium (1 g) H0D105 887 ug/mg (an) G (06/05) [61270-78-8]

1097705 Cefoperazone Dihydrate (200 mg) H G (12/99) [62893-19-0]

1097807 Ceforanide (200 mg) F-1 F (07/00) [60925-61-3]

1097909 Cefotaxime Sodium (250 mg) J0C189 901 ug/mg (ai) I (11/04) [64485-93-4]

1097975 Cefotetan (500 mg) I0E277 985 ug/mg (an) H0C175 (06/07)G (07/04)F (09/00)[69712-56-7] 1098005 Cefotiam Hydrochloride (325 mg) G0B050 F (01/03) [66309-69-1]

1098107 Cefoxitin (500 mg) J0E038 0.992 mg/mg (an) I (05/06)H (05/00)[35607-66-0]

1098118 Cefpiramide (300 mg) F0C203 [70797-11-4]

1098027 Cefpodoxime Proxetil (350 mg) F0C192 [87239-81-4]

1098049 Cefprozil (E)-Isomer (50 mg) G0D341 872 ug/mg (ai) F2C284 (08/05)F-1 (10/04)F

(05/01)[92676-86-3]

1098050 Cefprozil (Z)-Isomer (200 mg) H0E054 927 ug/mg (ai) G0C037(06/06)F (12/03)[121412-77-9] 1098129 Ceftazidime, Delta-3-Isomer (15 mg) H0E106 G (06/06)F (03/00)n/f

1098130 Ceftazidime Pentahydrate (300 mg) H G (12/99) [78439-06-2]

1098173 Ceftizoxime (350 mg) I0E262 (11/07)H (12/06)[68401-81-0]

1098184 Ceftriaxone Sodium (350 mg) G1D265 925 ug/mg (an) G0B264 (03/06)F (08/03)[104376-79-6] 1098195 Ceftriaxone Sodium E-Isomer (25 mg) I0C190 H (07/04)G (08/01)F-1 (02/00)n/f

1098209 Cefuroxime Sodium (200 mg) H G-1 (05/00) [56238-63-2]

1098220 Cefuroxime Axetil (500 mg) G F-1 (05/02) [64544-07-6]

1098231 Cefuroxime Axetil Delta-3-Isomers (15 mg) H1E186 (12/07)H0B160 (09/06)G (03/03)n/f 1098322 Cellaburate (350 mg) (Cellulose Acetate Butyrate)F0D220 [9004-36-8]

1098355 Cellacefate (125 mg) (Cellulose Acetate Phthalate)G0F177 F-1 (05/07)F (03/99)[9004-38-0] 1098300 Cellulose Acetate (125 mg) G0E015 F-1 (06/07)F (11/99)[9004-35-7]

1098388 Microcrystalline Cellulose (1 g) (AS) F0D362 [9004-34-6]

1098402 Powdered Cellulose (1 g) (AS) F0D364 [9004-34-6]

1098708 Cephaeline Hydrobromide (200 mg) G-1 n/f

1099008 Cephalexin (400 mg) J0D296 996 ug/mg (an) I-2 (10/05)I-1 (03/00)[23325-78-2] 1102000 Cephalothin Sodium (200 mg) I [58-71-9]

1102408 Cephapirin Benzathine (100 mg) F [97468-37-6]

1102500 Cephapirin Sodium (500 mg) J0F171 0.933 mg/mg (an) I-1 (06/07)I (07/02)[24356-60-3] 1102805 Cephradine (200 mg) J I (04/00) [58456-86-3]

1102974 Cetrimonium Bromide (1 g) F0F316 1 [57-09-0]

1103003 Cetyl Alcohol (100 mg) I1E065 I (07/06)H (03/99)[36653-82-4]

1103105 Cetyl Palmitate (50 mg) F0B241 [540-10-3]

1104006 Cetylpyridinium Chloride (500 mg) J0D299 1.000 mg/mg (an) I (10/05)H-1 (06/01)H

(08/99)[6004-24-6]

1105009 Powdered Chaste Tree Extract (1.5 g) F0C406 [91722-47-3]

1106001 Chlorambucil (125 mg) (FOR U.S. SALE ONLY) G F-1 (02/99) [305-03-3]

1107004 Chloramphenicol (200 mg) N1C074 N (10/04)M (03/00)[56-75-7]

1107300 Chloramphenicol Palmitate (200 mg) G-1 (12/07) [530-43-8]

1107401 Chloramphenicol Palmitate Nonpolymorph A (200 mg)F-1 [530-43-8]

1107503 Chloramphenicol Palmitate Polymorph A (100 mg)G1D219 G (10/05)F (08/99)[530-43-8] 1109000 Chlordiazepoxide CIV (200 mg) I0B063 H-1 (03/03) [58-25-3]

1110009 Chlordiazepoxide Hydrochloride CIV (200 mg) G-4 [438-41-5]

1110020 Chlordiazepoxide Related Compound A (25 mg)

(7-Chloro-1,3-dihydro-5-phenyl-2H-1,4-benzodiazepin-2-one 4-Oxide) G [963-39-3]

1111001 Chlorhexidine (200 mg) F0C306 [55-56-1]

1111103 Chlorhexidine Acetate (500 mg) H0F199 0.997 mg/mg (an) 2 G0E008 (11/07)F0C281

(02/06)[56-95-1]

1111307 Chlorhexidine Related Compounds (50 mg) F0D017 n/f

1112503 Chlorobutanol (200 mg) G1D301 G (09/05) F-3 (12/01)[6001-64-5]

1115545 Chlorogenic Acid (50 mg) F0C420 0.97 mg/mg (ai) [327-97-9]

1115556 beta-Chlorogenin (20 mg) F n/f

1496802 Parachlorophenol (500 mg) F0E061 0.99 mg/mg (ai) [106-48-9]

1117008 Chloroprocaine Hydrochloride (200 mg) G0B285 F-3 (01/04)F-2 (03/99)[3858-89-7] 1118000 Chloroquine Phosphate (500 mg) I H (10/99) [50-63-5]

1121005 Chlorothiazide (200 mg) H1E231 0.992 mg/mg HPLC (dr) 1.000 mg/mg UV (dr) H0B161 (11/06)G (04/03)[58-94-6]

1122008 Chlorotrianisene (1 g) F [569-57-3]

1122700 Chloroxylenol (125 mg) F2C259 F-1 (07/04)F (10/99)[88-04-0]

1122722 Chloroxylenol Related Compound A (25 mg) (2-chloro-3,5-dimethylphenol) G0C275 F-1 (07/04) [5538-41-0]

1123000 Chlorpheniramine Maleate (125 mg) M0B020 L-1 (06/03) [113-92-8]

1123102 Chlorpheniramine Maleate Extended-Release Tablets (Drug Release Calibrator, Single Unit) (60 Tablets) G0B259 F (06/03) [113-92-8]

1124003 Chlorphenoxamine Hydrochloride (200 mg) F-1 [562-09-4]

1125006 Chlorpromazine Hydrochloride (200 mg) J I (04/99) [69-09-0]

1126009 Chlorpropamide (200 mg) H [94-20-2]

1127001 Chlorprothixene (200 mg) F-1 [113-59-7]

1129007 Chlortetracycline Hydrochloride (200 mg) K0C185 1008 ug/mg (ai) J-1 (12/04)J

(02/02)[64-72-2]

1130006 Chlorthalidone (200 mg) I0C255 H-1 (11/04)H (07/99)[77-36-1]

1119309 Chlorthalidone Related Compound A (15 mg) (4’-Chloro-3’-sulfamoyl-2-benzophenone Carboxylic Acid) I0E270 0.99 mg/mg (ai) H0D251 (12/06)G0C376 (09/05)F-3 (07/04)n/f

1130505 Chlorzoxazone (500 mg) I H (07/01) [95-25-0]

1130527 Chlorzoxazone Related Compound A (50 mg)(2-Amino-4-chlorophenol)G-1 G (11/00) [95-85-2] 1131009 Cholecalciferol (30 mg/ampule; 5 ampules) (Vitamin D3) M0B157 L (10/03)K (09/99)[67-97-0]

1131803 Delta-4,6-cholestadienol (30 mg) F [14214-69-8]

1132001 Cholesteryl Caprylate (200 mg) F [1182-42-9]

1133004 Cholestyramine Resin (500 mg) I [11041-12-6]

1133503 Cholic Acid (2 g) (AS) F3B159 F-2 (01/03) [81-25-4]

1133536 Choline Bitartrate (200 mg) F0C057 [87-67-2]

1133547 Choline Chloride (200 mg) F0C058 [67-48-1]

1133570 Chondroitin Sulfate Sodium (300 mg) H0F184 1.00 mg/mg (dr) G0E236 (08/07)F0B256

(09/06)[39455-18-0]

1133638 Chromium Picolinate (100 mg) F [14639-25-9]

1134007 Chymotrypsin (300 mg) J0F105 1300 USP Chymotrypsin Units/mg (dr) I (07/07)H

(06/01)[9004-07-3]

1134018 Ciclopirox (50 mg) F0E086 [29342-05-0]

1134030 Ciclopirox Olamine (125 mg) I0F067 0.999 mg/mg (ai) H0C207 (05/07)G (05/03)[41621-49-2] 1134029 Ciclopirox Related Compound A (25 mg) (3-Cyclohexyl-4,5-dihydro-5-methyl-5-isoxazolyl acetic acid) F0E087 1.00 mg/mg (ai) n/f

1134040 Ciclopirox Related Compound B (25 mg) (6-Cyclohexyl-4-methyl-2-pyrone) F0E088 0.99 mg/mg (ai) [14818-35-0]

1134051 Cilastatin Ammonium Salt (100 mg) G0C334 945 ug/mg (ai) F-1 (05/05)F (07/00)n/f 1134062 Cimetidine (200 mg) I1C081 I (05/04) [51481-61-9]

1134073 Cimetidine Hydrochloride (200 mg) F [70059-30-2]

1134109 Cinoxacin (200 mg) F [28657-80-9]

1134313 Ciprofloxacin (200 mg) H0E306 0.998 mg/mg (ai) G-1 (02/07) G (05/01)[85721-33-1] 1134324 Ciprofloxacin Ethylenediamine Analog (25 mg) J0A030 I (01/03)H-1 (02/99)n/f

1134335 Ciprofloxacin Hydrochloride (400 mg) I0C265 H (02/05)G (04/00)[86393-32-0]

1134346 Ciprofloxacin Related Compound A (25 mg)(AS)

(7-Chloro-1-cyclopropyl-4-oxo-6-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic acid hydrochloride salt) F0E333 n/f

1134357 Cisplatin (100 mg) I0F250 0.998 mg/mg (ai) H (08/07)G (03/01)[15663-27-1]

1134233 Citalopram Hydrobromide (200 mg) F0F157 0.998 mg/mg (ai) [59729-32-7]

1134255 Citalopram Related Compound B (25 mg)

(1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-3-hydroxy-1,3-dihydroisobenzofuran-5-carboni trile oxalate) F0F212 n/f

1134277 Citalopram Related Compound D (15 mg)

(1-(4’-fluorophenyl)-1-(3-(methylamino)propyl)-1,3-dihydroisobenzofuran-5-carbonitrile hydrochloride) F0F170 n/f

1134288 Citalopram Related Compound E (25 mg)

(1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile-N-oxid

e hydrochloride) F0F208 n/f

1134299 Citalopram Related Compound F (200 mg) (dimethyl-(1-methyl-3,3-diphenyl-allyl)-amine hydrochloride) F0F169 [55011-89-7]

1134368 Citric Acid (200 mg) G0F161 1.000 mg/mg (dr) F2E269 (07/07)F1B092 (07/06)F-1 (01/04)F (07/02)[77-92-9]

1134211 Cladribine Related Compound A (20 mg) (2-methoxy-2’-deoxyadenosine) F0F244 1 [24757-70-8] 1134379 Clarithromycin (75 mg) G0D356 977 ug/mg (ai) F4B183 (03/06)F-3 (01/04)F-2

(09/01)[81103-11-9]

1134390 Clarithromycin Identity (100 mg) F0E141 [81103-11-9]

1134380 Clarithromycin Related Compound A (50 mg) (6,11-di-O-methylerythromycin A) G1E310 G (04/07)F (04/01)n/f

1134404 Clavam-2-carboxylate Potassium (4 ug) I0E130 H0C089 (05/07)G0B225 (12/03)F (10/03)n/f 1134426 Clavulanate Lithium (200 mg) I1C270 0.952 mg/mg (ai) I (02/05)H (09/02)n/f

1134506 Clemastine Fumarate (250 mg) J0C090 0.998 mg/mg (ai) I (09/06) H (10/00)[14976-57-9] 1135000 Clidinium Bromide (2 g) H0B115 G (03/05) [3485-62-9]

1135021 Clidinium Bromide Related Compound A (250 mg) (3-Hydroxy-1-methylquinuclindinium Bromide) I [76201-95-1]

1136002 Clindamycin Hydrochloride (200 mg) H0E044 867 ug/mg (ai) G4A017 (07/06)G-3 (07/03)G-2 (05/99)[58207-19-5]

1137005 Clindamycin Palmitate Hydrochloride (500 mg) G0D334 586 ug/mg (an) F-2 (11/05) [25507-04-4] 1138008 Clindamycin Phosphate (125 mg) I0C165 H-3 (04/04)H-2 (07/03)H-1 (02/99)[24729-96-2] 1138201 Clioquinol (500 mg) N0E020 0.992 mg/mg (dr) M (03/06)L-1 (01/03)[130-26-7]

1138405 Clobetasol Propionate (200 mg) G0F014 0.995 mg/mg (ai) F2C309 (07/07)F-1 (03/05)F (10/01)[25122-46-7]

1138427 Clobetasol Propionate Related Compound A (50 mg)

(9-alpha-fluoro-11-beta-hydroxy-16-beta-methyl-3-oxo-androsta-1,4-diene-17(R)-spiro-2’-[4’-chloro-5’-ethylfuran-3’(2’H)-one]) F2C417 F-1 (12/05)F (01/03)n/f

1138507 Clocortolone Pivalate (200 mg) G (12/07) [34097-16-0]

1138904 Clofazimine (200 mg) F1C392 100.00% F (03/07) [2030-63-9]

1139000 Clofibrate (1 g) I H (04/01) [637-07-0]

1140000 Clomiphene Citrate (500 mg) I0E164 0.995 mg/mg (an) (HPLC) 1.000 mg/mg (an) (UV)H (05/06)G-1 (10/99)[50-41-9]

1140101 Clomiphene Related Compound A (100 mg)

((E,Z)-2-[4-(1,2-diphenylethenyl)phenoxy]-N,Ndiethylethanamine Hydrochloride) F1B206 F (09/03) n/f

1140247 Clomipramine Hydrochloride (200 mg) F0C075 [17321-77-6]

1140305 Clonazepam CIV (200 mg) H0E003 0.999 mg/mg (ai) G1B175 (04/06)G (01/04)F-2

(01/00)[1622-61-3]

1140327 Clonazepam Related Compound A (25 mg) (3-Amino-4-(2-chlorophenyl)-6-nitrocarbostyril) G3F034 G2B110 (05/07)G-1 (01/04)G (02/99)n/f

1140338 Clonazepam Related Compound B (25 mg) (2-Amino-2’-chloro-5-nitrobenzophenone) H G (04/01) [2011-66-7]

1140349 Clonazepam Related Compound C (25 mg)

(2-Bromo-2’-(2-chlorobenzoyl)-4’-nitroacetanilide) G0F152 1.00 mg/mg (ai) F0C340 (07/07) n/f 1140393 Clonidine (200 mg) F0C401 [4205-90-7]

1140407 Clonidine Hydrochloride (200 mg) H0D106 1.000 mg/mg (dr) G (05/05) [4205-91-8] 1140418 Clonidine Related Compound A (25 mg) (Acetylclonidine)F0C373 [54707-71-0]

1140429 Clonidine Related Compound B (25 mg)

(2-[(E)-2,6-Dichlorophenylimino]-1-(1-{2-[(E)-2,6-dichlorophenylimino]-imidazolidin-1-yl}-et hyl)-imidazolidine) F0C403 0.99 mg/mg (ai) n/f

1140430 Clopidogrel Bisulfate (125 mg) G0F282 0.988 mg/mg (ai) 2 F0E115 (11/07) [120202-66-6]

1140586 Clopidogrel Related Compound A (20 mg)

((S)-(o-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetic acid, hydrochloride)

F0E117 1.18 mg/mg (bisulfate salt equivalent) (ai)[144750-42-5]

1140597 Clopidogrel Related Compound B (20 mg)

(Methyl(+/-)-(o-chlorophenyl)-4,5-dihydrothieno[2,3-c]pyridine-6(7H)-acetate, hydrochloride) F0E119 (12/07) [144750-52-7]

1140600 Clopidogrel Related Compound C (20 mg) (methyl

(-)-(R)-(o-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate, hydrogen sulfate)

F0E118 0.99 mg/mg (ai) [120202-71-3]

1140509 Clorazepate Dipotassium CIV (125 mg) G0B027 (12/07) F-1 (06/03)F (12/99)[57109-90-7] 1140702 Clorsulon (200 mg) F1B084 F (01/04) [60200-06-8]

1141002 Clotrimazole (200 mg) K0C282 J (02/05) I (05/99)[23593-75-1]

1141024 Clotrimazole Related Compound A (25 mg) ((ochlorophenyl) diphenylmethanol) I1D166 0.99 mg/mg (ai) I (11/05)H (10/01)G-1 (02/99)[66774-02-5]

1141909 Cloxacillin Benzathine (200 mg) F-1 F (03/02) [23736-58-5]

1142005 Cloxacillin Sodium (200 mg) L0B086 K (01/04) [7081-44-9]

1142107 Clozapine (100 mg) G0D315 1.000 mg/mg (dr) F0C032 (11/05) [5786-21-0]

1143008 Cocaine Hydrochloride CII (250 mg) I0B074 H-2 (01/04)H-1 (02/99)[53-21-4]

1145207 Cod Liver Oil (1 g) F0D400 [8001-69-2]

1143802 Codeine N-Oxide CI (50 mg) G0A034 F-1 (11/02) [3688-65-1]

1144000 Codeine Phosphate CII (100 mg) J0C200 I-1 (10/04)I (09/02)H-1 (01/00)[41444-62-6] 1145003 Codeine Sulfate CII (250 mg) H-2 H-1 (01/02) [6854-40-6]

1146006 Colchicine (300 mg) K0F231 0.994 mg/mg (an) J (08/07)I (05/02)[64-86-8]

1146505 Colestipol Hydrochloride (200 mg) F-1 [37296-80-3]

1147009 Colistimethate Sodium (200 mg) H1D234 0.420 mg/mg (dr) H (09/05) [8068-28-8] 1148001 Colistin Sulfate (200 mg) G-1 G (09/99) [1264-72-8]

1148500 Copovidone (100 mg) F0C194 [2586-89-9]

1148806 Corn Oil (1 g) (AS) F0D181 [8001-30-7]

1149004 Corticotropin (5.6 Units/vial; 5 vials) M L (06/99) [9002-60-2]

1150003 Cortisone Acetate (150 mg) I [50-04-4]

1150207 Cottonseed Oil (1 g) (AS) F0D173 [8001-29-4]

1150353 Creatinine (100 mg) F [60-27-5]

1150502 Cromolyn Sodium (500 mg) J1E187 1.000 mg/mg (an) J (11/06)I (06/00)[15826-37-6] 1150513 Cromolyn Sodium Related Compound A (25 mg)

(1,3-Bis-(2-acetyl-3-hydroxyphenoxy)-2-propanol) (AS) F0E045 [16150-44-0]

1150706 Crospovidone (200 mg) G2E126 G1C273 (06/07)G (12/04)[9003-39-8]

1151006 Crotamiton (200 mg) H-1 H (07/00) [483-63-6]

1151709 Cumene (1.2 mL/ampule; 3 ampules) F0E215 1.00 mg/mg (ai) [98-82-8]

1152009 Cyanocobalamin (1.5 g of mixture with mannitol; 10.7 mcg/mg of mixture) (Vitamin B12) N M-3 (08/99) [68-19-9]

1152508 Cyclacillin (200 mg) G [3485-14-1]

1152701 Cyclandelate (200 mg) F0C384 [456-59-7]

1154004 Cyclizine Hydrochloride (200 mg) H0D321 1.000 mg/mg (dr) G (10/05) [303-25-3] 1154503 Cyclobenzaprine Hydrochloride (200 mg) G0A013 F-3 (07/03) [6202-23-9]

1154558 Alpha Cyclodextrin (50 mg) F-1 F (10/00) [10016-20-3]

1154569 Beta Cyclodextrin (250 mg) G F-1 (12/02) [7585-39-9]

1154707 Cyclomethicone 4 (200 mg) F-2 F-1 (06/02) [69430-24-6]

1154809 Cyclomethicone 5 (200 mg) G0D052 F-2 (07/05) F-1 (09/99) [69430-24-6]

1154900 Cyclomethicone 6 (200 mg) F2B024 F-1 (03/03) [69430-24-6]

1156000 Cyclopentolate Hydrochloride (300 mg) I0C424 0.999 mg/mg (dr) H (03/05)G

(04/00)[5870-29-1]

1157002 Cyclophosphamide (500 mg) (FOR U.S. SALE ONLY) J1B200 J (02/05) [6055-19-2]

1157501 2-Cyclopropylmethylamino-5-chlorobenzophenone (50 mg) F n/f

1158005 Cycloserine (200 mg) G [68-41-7]

1158504 Cyclosporine (50 mg) H-1 (12/07) H (11/02)G-2 (03/00)[59865-13-3]

1158650 Cyclosporine Resolution Mixture (25 mg) F1F134 F (05/07) [108027-45-8](U)

1159008 Cyclothiazide (200 mg) F-1 [2259-96-3]

1161000 Cyproheptadine Hydrochloride (500 mg) G F-4 (11/02) [41354-29-4]

1161509 L-Cysteine Hydrochloride (200 mg) H G (05/00) [7048-04-6]

1162002 Cytarabine (250 mg) G3F139 0.996 mg/mg (ai) G-2 (08/07) G-1 (07/00)[147-94-4] 1162148 Cytosine (100 mg) F0E284 1.00 mg/mg (dr) [71-30-7]

1162308 Dacarbazine (125 mg) H G (01/99) [4342-03-4]

1162320 Dacarbazine Related Compound A (50 mg) (5-aminoimidazole-4-carboxamide Hydrochloride) H0C052 G (03/04)F (03/00)[72-40-2]

1162330 Dacarbazine Related Compound B (50 mg) (2-azahypoxanthine) G0C325 F-1 (03/05)F

(12/01)[63907-29-9]

1162400 Dactinomycin (50 mg) I [50-76-0]

1162501 Danazol (200 mg) I0F168 0.999 mg/mg (dr) H (07/07)G (10/00)[17230-88-5]

1164008 Dapsone (125 mg) H0D260 0.998 mg/mg (dr) G-3 (02/06)G-2 (08/99)[80-08-0]

1164700 Daunorubicin Hydrochloride (200 mg) L0B307 K (11/03)J (08/00)[23541-50-6]

1165000 Decamethonium Bromide (250 mg) F [541-22-0]

1166003 Deferoxamine Mesylate (500 mg) I [138-14-7]

1166309 Dehydroacetic Acid (200 mg) F [520-45-6]

1166400 Dehydrocarteolol Hydrochloride (100 mg) F n/f

1166502 Dehydrocholic Acid (200 mg) F-1 F (03/04) [81-23-2]

1169001 Demecarium Bromide (250 mg) F [56-94-0]

1170000 Demeclocycline Hydrochloride (200 mg) H1C036 H (08/04)G-1(08/01)[64-73-3]

1046089 N-Demethylazithromycin (15 mg) F0E068 0.92 mg/mg (ai) n/f

1171003 Denatonium Benzoate (200 mg) I1F025 1.000 mg/mg (dr) I0B129 (03/07)H (09/02)[86398-53-0] 1171251 2-Deoxy-D-Glucose (100 mg) (AS) F0E006 [154-17-6]

1171706 Desacetyl Diltiazem Hydrochloride (50 mg) J0C143 1.00 mg/mg (ai) I (07/05)H

(08/00)[23515-45-9]

1171900 Desflurane (0.5 mL) F0C187 [57041-67-5]

1171910 Desflurane Related Compound A (0.1 mL) (bis-(1,2,2,2-tetrafluoroethyl) ether) F0C031 n/f 1172006 Desipramine Hydrochloride (125 mg) I0E283 1.000 mg/mg (dr) H-1 (11/06)H (10/99)[58-28-6] 1173009 Deslanoside (100 mg) H-1 [17598-65-1]

1173235 Desogestrel (50 mg) G1F145 0.998 mg/mg (ai) G0C390 (10/07)F0B282 (11/04)[54024-22-5] 1173246 Desogestrel Related Compound A (15 mg) (13-Ethyl-11-methylene-18, 19-dinor-5alpha,

17alpha-preg-3-en-20-yl-17-ol, desogestrel delta-3 isomer) F0B279 n/f

1173257 Desogestrel Related Compound B (15 mg) (3-Hydroxy-desogestrel) G0F144 0.96 mg/mg (ai) F0B284 (03/07) n/f

1173268 Desogestrel Related Compound C (25 mg) (3-Keto-desogestrel) F0B281 [54048-10-1] 1046078 Desosaminylazithromycin (15 mg) F0E067 0.99 mg/mg (ai) n/f

1173508 Desoximetasone (200 mg) H0B036 G (01/04) [382-67-2]

1174001 Desoxycorticosterone Acetate (200 mg) J0C014 I (01/04)H (05/00)[56-47-3]

1175004 Desoxycorticosterone Pivalate (125 mg) H0C276 G (01/04) [808-48-0]

1176007 Dexamethasone (125 mg) J [50-02-2]

1176506 Dexamethasone Acetate (200 mg) H0E339 0.996 mg/mg (dr) G (12/06)F-1 (06/99)[1177-87-3] 1177000 Dexamethasone Phosphate (200 mg) K0E275 0.996 mg/mg (dr) J1B070 (01/07)J (08/03)I (03/00)[312-93-6]

1178002 Dexbrompheniramine Maleate (200 mg) J I (03/03) [2391-03-9]

1179005 Dexchlorpheniramine Maleate (300 mg) H0D199 0.999 mg/mg (ai) G1A025 (11/05)G

(12/02)[2438-32-6]

1179504 Dexpanthenol (500 mg) J0C293 I (08/04)H (02/02)[81-13-0]

1179628 Dextran 1 (50 mg) F0D297 [9004-54-0]

1179708 Dextran 40 (50 mg) F0C247 [9004-54-0]

1179741 Dextran 70 (50 mg) F0C260 [9004-54-0]

1179854 Dextran 4 Calibration (100 mg) F0C002 [9004-54-0]

1179865 Dextran 10 Calibration (100 mg) F0C010 [9004-54-0]

1179876 Dextran 40 Calibration (100 mg) F0C011 [9004-54-0]

1179720 Dextran 40 System Suitability (200 mg) F0B181 [9004-54-0]

1179887 Dextran 70 Calibration (100 mg) F0C013 [9004-54-0]

1179763 Dextran 70 System Suitability (200 mg) F0B182 [9004-54-0]

1179898 Dextran 250 Calibration (100 mg) F0C039 [9004-54-0]

1179650 Dextran T-10 (200 mg) F0D238 1.000 mg/mg (dr) [9004-54-0]

1179800 Dextran Vo Marker (100 mg) F0B242 [9004-54-0]

1180004 Dextroamphetamine Sulfate CII (500 mg) I0C311 1.000 mg/mg (dr) H (05/05)G (08/03)F-6 (12/99)[51-63-8]

1180503 Dextromethorphan (2 g) H G (06/00) [125-71-3]

1181007 Dextromethorphan Hydrobromide (500 mg) J0B167 I (07/03) [6700-34-1]

1181302 Dextrose (500 mg) J2E294 0.999 mg/mg (dr) J-1 (04/07)J (11/02)I (08/99)[50-99-7] 1181506 Diacetylated Monoglycerides (200 mg) G [68990-54-5]

1182000 Diacetylfluorescein (200 mg) H G (01/02) [596-09-8]

1183002 Diacetylmorphine Hydrochloride CI (25 mg) (AS) (Heroin Hydrochloride) J I-1 (10/99) [1502-95-0]

1184005 Diatrizoic Acid (100 mg) H0E084 G (04/06) [50978-11-5]

1184027 Diatrizoic Acid Related Compound A (50 mg) (5-Acetamido-3-amino-2,4,6-triiodobenzoic Acid) I H (02/00) [1713-07-1]

1185008 Diazepam CIV (100 mg) I1C364 0.999 mg/mg (ai) I (02/06)H (12/01)[439-14-5]

1185020 Diazepam Related Compound A (25 mg) (2-Methyl-amino-5-chlorobenzophenone)I1F077 1.00 mg/mg (ai) 2 I (12/07)H-1 (11/02)H (04/00)[1022-13-5]

1023403 Diazepam Related Compound B (25 mg) (3-Amino-6-chloro-1-methyl-4-phenylcarbostyril)

I1C102 I (12/04)H (04/01)[5220-02-0]

1186000 Diazoxide (200 mg) H0F314 0.999 mg/mg (ai) 2 G1C017 (11/07) G (12/03)[364-98-7] 1187003 Dibucaine Hydrochloride (200 mg) I H-2 (01/03) [61-12-1]

1187080 Dibutyl Phthalate (200 mg) F0D125 [84-74-2]

1187091 Dibutyl Sebacate (1 mL) (AS) F0D128 99.2% (ai) [109-43-3]

1187207 Dichloralphenazone CIV (200 mg) F0B010 [480-30-8]

1187954 2,4-Dichlorophenol (100 mg) F0E113 0.99 mg/mg (ai) [120-83-2]

1188006 Dichlorphenamide (200 mg) G2C046 G-1 (05/07) [120-97-8]

1188301 Dichlorvos (150 mg) (2,2-dichlorovinyl dimethyl phosphate) (AS)F0D141 [62-73-7] 1188800 Diclofenac Sodium (200 mg) H0B150 G-1 (03/04)G (05/01)[15307-79-6]

1188709 Diclofenac Potassium (200 mg) F0F269 1.000 mg/mg (dr) 1 [15307-81-0]

1188811 Diclofenac Related Compound A (50 mg) (N-(2,6-dichlorophenyl)indolin-2-one) I0D337 1.00 mg/mg (ai) H (06/06)G (05/02)[15362-40-0]

1189009 Dicloxacillin Sodium (500 mg) J0C182 I0B142 (09/04)H (05/03)[13412-64-1]

1190008 Dicumarol (200 mg) G [66-76-2]

1191000 Dicyclomine Hydrochloride (125 mg) H G (03/99) [67-92-5]

1192003 Dienestrol (125 mg) I [84-17-3]

1192808 Diethanolamine (3 mL) F0D118 [111-42-2]

1193006 Diethylcarbamazine Citrate (200 mg) G-1 [1642-54-2]

1193301 Diethylene Glycol Monoethyl Ether (0.5 mL/ampule) G0C159 F0B095 (09/06) [111-90-0] 1193505 Diethyl Phthalate (200 mg) G F-1 (03/00) [84-66-2]

1194009 Diethylpropion Hydrochloride CIV (200 mg) H (11/07) [134-80-5]

1195001 Diethylstilbestrol (200 mg) K5B291 K-4 (05/04) [56-53-1]

1197007 Diethyltoluamide (3 g) H1D076 0.981 mg/mg (an) H (11/06) [134-62-3]

1197302 Diflorasone Diacetate (200 mg) G F-1 (03/00) [33564-31-7]

1197506 Diflunisal (200 mg) G [22494-42-4]

1198000 Digitalis (3 g) F [8031-42-3]

1199002 Digitoxin (200 mg) M [71-63-6]

1200000 Digoxin (250 mg) O0B096 N-1 (04/03) [20830-75-5]

1200600 Dihydrocapsaicin (25 mg) H0F210 1.00 mg/mg (ai) G0C071 (09/07)F-1 (12/03)F

(01/00)[19408-84-5]

1200804 Dihydrocodeine Bitartrate CII (200 mg) I0D205 0.997 mg/mg (dr) H (09/05)G

(03/01)[5965-13-9]

1201002 17alpha-Dihydroequilin (50 mg) I0C277 H (07/04) [6639-99-2]

1202005 Dihydroergotamine Mesylate (250 mg) (List Chemical)J0B085 I (03/03) [6190-39-2] 1203008 Dihydrostreptomycin Sulfate (200 mg) J [5490-27-7]

1204000 Dihydrotachysterol (30 mg/ampule; 4 ampules) J0D250 0.996 mg/mg (ai) I (06/05) [67-96-9] 1204102 Dihydroxyacetone (250 mg) F [96-26-4]

1204805 Diloxanide Furoate (200 mg) F0C026 [3736-81-0]

1205003 Diltiazem Hydrochloride (200 mg) J0F005 0.999 mg/mg (dr) 2 I (11/07) [33286-22-5] 1206006 Dimenhydrinate (100 mg) J0B055 I (06/03) [523-87-5]

1208001 Dimethisoquin Hydrochloride (2 g) G [2773-92-4]

1210105 N-(3-Dimethylamino-propyl)-2-aza-8,8-diethyl-8-germaspiro [4:5]decane-1,3-dione (AS) DISCONTINUED F (10/07) [41992-23-8]

1211006 Dimethyl Sulfoxide (3 g) H0D273 0.999 mg/mg (ai) G0C198 (10/06)F-3 (07/04)F-2

(05/02)[67-68-5]

1213001 Dinoprost Tromethamine (50 mg) F [38562-01-5]

1213103 Dinoprostone (50 mg) F0C030 [363-24-6]

1214004 Dioxybenzone (150 mg) F1B277 F (10/03) [131-53-3]

1217909 Diphenhydramine Citrate (125 mg) H1C350 1.000 mg/mg (dr) H0B128 (08/06)G

(04/03)[88637-37-0]

1218005 Diphenhydramine Hydrochloride (200 mg) J0B013 I (07/03) [147-24-0]

1219008 Diphenoxylate Hydrochloride CII (200 mg) I1D339 0.998 mg/mg (dr) I (08/06)H

(03/02)[3810-80-8]

1220302 Dipivefrin Hydrochloride (200 mg) I H (06/99) [64019-93-8]

1220506 Dipyridamole (200 mg) H1F120 0.998 mg/mg (dr) H (06/07)G-1 (01/99)[58-32-2]

1220700 Dirithromycin (200 mg) F [62013-04-1]

1221000 Disodium Guanylate (300 mg) (FCC) F-1 [5550-12-9]

1222002 Disodium Inosinate (500 mg) (FCC) F [4691-65-0]

1222501 Disopyramide Phosphate (200 mg) I0E337 1.000 mg/mg (dr) H-1 (08/07)H (03/02)[22059-60-5] 1223005 2,4-Disulfamyl-5-trifluoromethylaniline (125 mg) G [654-62-6]

1224008 Disulfiram (200 mg) F-3 F-2 (07/02) [97-77-8]

1224507 Dobutamine Hydrochloride (600 mg) H-1 H (01/00) [49745-95-1]

1224664 Docosyl Ferulate (50 mg) F0E143 0.99 mg/mg (ai) 1 [101927-24-6]

1224700 Docusate Calcium (500 mg) H0B044 G-1 (07/02) [128-49-4]

1224802 Docusate Sodium (500 mg) K0D134 0.988mg/mg (an) J (09/05)I-1 (05/02)[577-11-7] 1224904 Docusate Potassium (100 mg) F-1 F (11/99) [7491-09-0]

1224959 Dolasetron Mesylate (200 mg) F0C319 [115956-13-3]

1224960 Dolasetron Mesylate Related Compound A (25 mg)

(Hexahydro-8-hydroxy-2,6-methano-2H-quinolizin-3(4H)-one hydrochloride) F0C321 n/f

1225204 Dopamine Hydrochloride (200 mg) G F-5 (05/02) [62-31-7]

1225281 Dorzolamide Hydrochloride (200 mg) G0E278 0.998 mg/mg (ai) F0C040 (11/06) [130693-82-2] 1225292 Dorzolamide Hydrochloride Related Compound A (20 mg)

((4R,6R)-4-(ethylamino)-5,6-dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-2-sulfonamide-7,7-dio xide, monohydrochloride) G0E029 F0C068 (12/05) n/f

1225000 Doxapram Hydrochloride (200 mg) F4C053 F-3 (07/04) [7081-53-0]

1225419 Doxazosin Mesylate (200 mg) G0E173 0.997 mg/mg (ai) F0C079 (08/06) [77883-43-3] 1225500 Doxepin Hydrochloride (500 mg) I [1229-29-4]

1225703 Doxorubicin Hydrochloride (50 mg) K J (06/02) [25316-40-9]

1226003 Doxycycline Hyclate (200 mg) J0E174 859 ug/mg (ai ) (chromatographic) 864 ug/mg ( a i ) (spectroscopic) I (09/06)H (01/00)[24390-14-5]

1227006 Doxylamine Succinate (300 mg) I1F141 0.998 mg/mg (ai) I0B266 (10/07)H (01/04)[562-10-7] 1229001 Droperidol (250 mg) I0C029 H-1 (01/05)H (04/99)[548-73-2]

1230000 Dyclonine Hydrochloride (200 mg) G [536-43-6]

1231003 Dydrogesterone (200 mg) I0B114 H (01/04) [152-62-5]

1231502 Dyphylline (200 mg) G-2 G-1 (11/02) [479-18-5]

1231728 Powdered Echinacea Purpurea Extract (1 g) F0D018 [90028-20-9]

1231706 Powdered Echinacea Angustifolia Extract (1 g) F0D019 [84696-11-7]

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921WATER DETERMINATION水分测定 Many Pharmacopeial articles either are hydrates or contain water in adsorbed form. As a result, the determination of the water content is important in demonstrating compliance with the Pharmacopeial standards. Generally one of the methods given below is called for in the individual monograph, depending upon the nature of the article. In rare cases, a choice is allowed between two methods. When the article contains water of hydration, the Method I (Titrimetric), the Method II (Azeotropic), or the Method III (Gravimetric) is employed, as directed in the individual monograph, and the requirement is given under the heading Water. 很多药典物品要么是水合物，要么含有处于吸附状态的水。因此，测定水分含量对于证实与药典标准的符合性是很重要的。通常，在具体的各论中会根据该物品的性质，要求使用下面若干方法中的一个。偶尔，会允许在2个方法中任选一个。当该物品含有水合状态的水，按照具体各论中的规定，使用方法I（滴定测量法）、方法II（恒沸测量法）、或方法III（重量分析法），这个要求在标题水分项下给出。 The heading Loss on drying (see Loss on Drying 731) is used in those cases where the loss sustained on heating may be not entirely water. 在加热时的持续失重可能不全是水分的情况下，使用标题干燥失重（见干燥失重<731>）。 METHOD I (TITRIMETRIC) 方法I（滴定测量法） Determine the water by Method Ia, unless otherwise specified in the individual monograph. 除非具体各论中另有规定，使用方法Ia来测定水分。 Method Ia (Direct Titration) 方法Ia（直接滴定） Principle— The titrimetric determination of water is based upon the quantitative reaction of water with an anhydrous solution of sulfur dioxide and iodine in the presence of a buffer that reacts with hydrogen ions. 原理：水分的滴定法检测是基于水与二氧化硫的无水溶液以及存在于缓冲液中与氢离子反应的碘之间的定量反应。 In the original titrimetric solution, known as Karl Fischer Reagent, the sulfur dioxide and iodine are dissolved in pyridine and methanol. The test specimen may be titrated with the Reagent directly, or the analysis may be carried out by a residual titration procedure. The stoichiometry of the reaction

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USP 40 Official Monographs / Levofloxacin 4831 Acceptance criteria: See Table 1. Sample solution: 1mg/mL of Levofloxacin in Mobile phase Chromatographic system Table 1(See Chromatography ?621?, System Suitability .)Relative Relative Acceptance Mode: LC Retention Response Criteria,Detector: UV 360 nm Name Time Factor NMT (%) Column: 4.6-mm × 25-cm; 5-μm packing L1Levodopa related Column temperature: 45°compound A 0.90.830.1Flow rate: 0.8mL/min Injection size: 25μL Levodopa 1.0——System suitability Levodopa related Sample: Standard solution compound B 2.8 0.83 0.5 Suitability requirements 5,6-Dihydroxy-in-Tailing factor: 0.5–1.5 dole-2-carboxylic Relative standard deviation: NMT 1.0%acid 6.0 2.5 0.1Analysis 0.1Samples: Standard solution and Sample solution individual Calculate the percentage of levofloxacin (C 18H 20FN 3O 4)— 0.3 total in the portion of Levofloxacin taken: Unknown impurities 1.0unknown Total impurities — — 1.1 Result = (r U /r S ) × (C S /C U ) × 100 r U = peak response of levofloxacin from the Sample ADDITIONAL REQUIREMENTS solution ?P ACKAGING AND S TORAGE : Preserve in tight, light-resistant r S = peak response of levofloxacin from the containers, in a dry place, and prevent exposure to ex-Standard solution cessive heat. C S = concentration of USP Levofloxacin RS in the ?USP R EFERENCE S TANDARDS ?11?Standard solution (mg/mL) USP Levodopa RS C U = concentration of Levofloxacin in the Sample USP Levodopa Related Compound A RS solution (mg/mL) 3-(3,4,6-Trihydroxyphenyl)alanine.Acceptance criteria: 98.0%–102.0% on the anhydrous C 9H 11NO 5213.19 basis USP Levodopa Related Compound B RS 3-Methoxytyrosine.IMPURITIES C 10H 13NO 4211.22 ?R ESIDUE ON I GNITION ?281?: NMT 0.2%. Use a platinum crucible. Delete the following: Levofloxacin ??H EAVY M ETALS , Method II ?231?: NMT 10ppm ?(Official 1-Jan-2018) ?O RGANIC I MPURITIES , P ROCEDURE 1 [N OTE —Procedure 1 is recommended if levofloxacin N -ox-ide is a potential organic impurity. Procedure 2 and Pro-cedure 3 are recommended if levofloxacin related com-pound B is a potential organic impurity.] Solution A, Mobile phase, Sample solution, and Chro-matographic system: Proceed as directed in the C 18H 20FN 3O 4·1/2H 2O 370.38Assay . 7H -Pyrido[1,2,3-de ]-1,4-benzoxazine-6-carboxylic acid, System suitability solution: 1mg/mL of USP Levoflox-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-acin RS in Mobile phase 7-oxo-hydrate (2:1), (S )-; Sensitivity solution: 0.3μg/mL of USP Levofloxacin RS (?)-(S )-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piper-in Mobile phase azinyl)-7-oxo-7H -pyrido[1,2,3-de ]-1,4-benzoxazine-6-car-System suitability boxylic acid, hemihydrate [138199-71-0].Samples: System suitability solution and Sensitivity Anhydrous [100986-85-41]. solution Suitability requirements DEFINITION Relative standard deviation: NMT 1.0%, System suit-Levofloxacin contains NLT 98.0% and NMT 102.0% of ability solution C 18H 20FN 3O 4, calculated on the anhydrous basis.Signal-to-noise ratio: NLT 10, Sensitivity solution IDENTIFICATION Analysis ?A . I NFRARED A BSORPTION ?197K ? Sample: Sample solution ?B . The retention time of the major peak of the Sample Calculate the percentage of each individual impurity in solution corresponds to that of the Standard solution , as the portion of Levofloxacin taken: obtained in the Assay.Result = (r U /r S ) × (1/F ) × 100 ASSAY ?P ROCEDURE r U = peak response of each impurity Buffer: 8.5g/L of ammonium acetate, 1.25g/L of cu-r S = peak response of levofloxacin pric sulfate, pentahydrate, and 1.3g/L of L -isoleucine in F = relative response factor (see Table 1)water Acceptance criteria: See Table 1. Mobile phase: Methanol and Buffer (3:7) Standard solution: 1mg/mL of USP Levofloxacin RS in Mobile phase USP Monographs

美国药典USP31(921)翻译版(下)

Method Ib (Residual Titration) 方法Ib（残留滴定）Principle— See the information given in the section Principle under Method Ia. In the residual titration, excess Reagent is added to the test specimen, sufficient time is allowed for the reaction to reach completion, and the unconsumed Reagent is titrated with a standard solution of water in a solvent such as methanol. The residual titration procedure is applicable generally and avoids the difficulties that may be encountered in the direct titration of substances from which the bound water is released slowly. 原理：见方法Ia项下原理部分给出的信息。在残留滴定中，额外的试剂被加入到供试样品中，为反应的完成留下了充分的时间，并且将未消耗掉的试剂与水和某种溶剂（例如，甲醇）的标准溶液一起滴定。残留滴定程序通常是可行的，并避免了可能在直接滴定该物质过程中遇到的困难，这些物质中被束缚水分释放得很缓慢。 Apparatus, Reagent, and Test Preparation— Use Method Ia. 仪器、试剂、供试配制液：同方法Ia。 Standardization of Water Solution for Residual Titration— Prepare a Water Solution by diluting 2 mL of water with methanol or other suitable solvent to 1000 mL. Standardize this solution by titrating 25.0 mL with the Reagent, previously standardized as directed under Standardization of the Reagent. Calculate the water content, in mg per mL, of the Water Solution taken by the formula: 用于残留滴定的水溶液的标准化：以甲醇或其他适当溶剂将2mL水稀释至1000mL，以配制水溶液。使用此前已经按照试剂的标准化项下规定进行过标准化的试剂，对25mL此溶液进行滴定，从而对其进行标准化。按照下面的公式，计算此水溶液中的水分含量（单位mg/mL）： V F/25,

美国药典USP31翻译版

Many Pharmacopeial articles either are hydrates or contain water in adsorbed form. As a result, the determination of the water content is important in demonstrating compliance with the Pharmacopeial standards. Generally one of the methods given below is called for in the individual monograph, depending upon the nature of the article. In rare cases, a choice is allowed between two methods. When the article contains water of hydration, the Method I (Titrimetric), the Method II (Azeotropic), or the Method III (Gravimetric) is employed, as directed in the individual monograph, and the requirement is given under the heading Water.很多药典物品要么是水合物，要么含有处于吸附状态的水。因此，测定水分含量对于证实与药典标准的符合性是很重要的。通常，在具体的各论中会根据该物品的性质，要求使用下面若干方法中的一个。偶尔，会允许在2个方法中任选一个。当该物品含有水合状态的水，按照具体各论中的规定，使用方法I（滴定测量法）、方法II（恒沸测量法）、或方法III（重量分析法），这个要求在标题水分项下给出。 The heading Loss on drying (see Loss on Drying 731) is used in those cases where the loss sustained on heating may be not entirely water. 在加热时的持续失重可能不全是水分的情况下，使用标题干燥失重（见干燥失重<731>）。 METHOD I (TITRIMETRIC) 方法I（滴定测量法） Determine the water by Method Ia, unless otherwise specified in the individual monograph.除非具体各论中另有规定，使用方法Ia来测定水分。 Method Ia (Direct Titration) 方法Ia（直接滴定） Principle—The titrimetric determination of water is based upon the quantitative reaction of water with an anhydrous solution of sulfur dioxide and iodine in the presence of a buffer that reacts with hydrogen ions. 原理：水分的滴定法检测是基于水与二氧化硫的无水溶液以及存在于缓冲液中与氢离子反应的碘之间的定量反应。 In the original titrimetric solution, known as Karl Fischer Reagent, the sulfur dioxide and iodine are dissolved in pyridine and methanol. The test specimen may be titrated with the Reagent directly, or the analysis may be carried out by a residual titration procedure. The stoichiometry of the reaction is not exact, and the reproducibility of a determination depends upon such factors as the relative concentrations of the Reagent ingredients, the

USP美国药典,二甘醇、乙二醇及其他杂质

Glycerin C 3H 8O 3 92.10 1,2,3-Propanetriol. Glycerol [56-81-5]. ? Glycerin contains not less than 99.0 percent and not more than 101.0 percent of C 3H 8O 3, calculated on the anhydrous basis. The amount of any individual impurity, excluding diethylene glycol and ethylene glycol, if detected, meets the requirements under Other Impurities (NMT 0.1%) and the amount of total impurities, including diethylene glycol and ethylene glycol, is NMT 1.0%. Packaging and storage— Preserve in tight containers. USP Reference standards 11— USP Diethylene Glycol RS . USP Ethylene Glycol RS . USP Glycerin RS . Color— Its color, when viewed downward against a white surface in a 50-mL color-comparison tube, is not darker than the color of a standard made by diluting 0.40 mL of ferric chloride CS with water to 50 mL and similarly viewed in a color-comparison tube of approximately the same diameter and color as that containing the Glycerin. Identification— [NOTE—Compliance is determined by meeting the requirements for both Identification A and B .] A: Infrared Absorption 197F . B: Standard stock solution 1—Transfer 50 mg of USP Diethylene Glycol RS , accurately weighed, to a 100-mL volumetric flask, dilute with methanol to volume, and mix. Standard stock solution 2— Transfer 50 mg of USP Ethylene Glycol RS , accurately weighed, to a 100-mL volumetric flask, dilute with methanol to volume, and mix. Standard stock solution 3— Transfer 50 mg of USP Glycerin RS , accurately weighed, to a 100-mL volumetric flask, dilute with methanol to volume, and mix. Resolution solution— Transfer 5.0 mL each of Standard stock solution 1, Standard stock solution 2, and Standard stock solution 3, to a 100-mL volumetric flask, dilute with

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USP《671》美国药典-包装容器——性能检测译文

《 671》包装容器——性能检测本章规定了用来包装的塑料容器及其组件功能性质上的标准(药品、生物制剂、营养补充剂和医疗器械 )，定义了保存、包装、存储和标签方面的凡例与要求。本文提供的试验用于确定塑料容器的透湿性和透光率。盛装胶囊和片剂的多单元容器章节适用于多单元容器。盛装胶囊和片剂的单位剂量容器章节适用于单位剂量容器。盛装胶囊和片剂的多单元容器 (没有密封 ) 的章节适用于没有密封的聚乙烯和聚丙烯容器。盛装液体的多元和单元容器的章节适用于多元的和单元的容器。一个容器想要提供避光保护或作为一个符合耐光要求的容器，由具有耐光的特殊性质的材料组成，包括任何涂层应用。一个无色透明或半透明的容器通过一个不透明的外壳包装变成耐光的 (见凡例和要求 )，可免于对光的透射要求。在多单元容器和封盖与水泡的单位剂量容器由衬垫密封情况下，此处使用的术语“容器”指的是整个系统的组成。盛装胶囊和片剂的多元容器干燥剂——放置一些颗粒 4— 8 目的无水氯化钙在一个浅的容器里，仔细剔除细粉，然后置于110°干燥，并放在干燥器中冷却。试验过程——挑选 12 个类型和尺寸一致的容器，用不起毛的毛巾清洁密闭表面，并打开和关闭每个容器 30 次。坚决每次应用容器密闭一致。通过扭矩关闭螺旋盖容器，使气密性在附表规定的范围内。 10 个指定的测试容器添加干燥剂，如果容器容积大于等于20mL，每个填充 13mm以内封闭；如果容器的容积小于 20 毫升，每个填充容器容量的三分之二。如果容器内部的深度超过 63mm，惰性填料或垫片可以放置在底部来最小化容器和干燥剂的总重量；干燥剂层在这样一个容器中深度不低于 5cm。添加干燥剂之后，立即按附表中规定的扭矩封闭螺旋帽容器。剩余的 2 个指定为对照容器，每个添加足够数量的玻璃珠，重量约等于每个测试容器的重量，并用附表中规定的扭矩封闭螺旋帽容器。记录各个容器的重量，如果容器的容积小于 20 毫升，精确到 0.1 毫克；如果容器容积为 20 毫升或以上但小于 200 毫升，精确到毫克；如果容器容积为 200 毫升及以上，精确到厘克（10 毫克）；在相对湿度 75±3%和温度 23±2°的环境下存储。 [ 注意——浓度为 35g/100mL 的氯化钠溶液放在干燥器底部的渗透系统来维持指定湿度。其他的方法可以用来维护这些条件。 ] 336±1小时（ 14 天）后，用同样的办法记录每个容器的重

美国药典USP32-重金属测试

<231> 重金属本试验系在规定的试验条件下，金属离子与硫化物离子反应显色，通过制备的标准铅溶液目视比较测定，以确证供试品中重金属杂质含量不超过各论项下规定的限度（以供试品中铅的百分比表示，以重量计）。（见分光光度法和光散射项下测定法目视比较法<851>）[ 注意:对本试验有响应的典型物质有铅、汞、铋、砷、锑、锡、镉、银、铜和钼等]。除各论另有规定外，按第一法测定重金属。第一法适用于在规定试验条件下，能产生澄清、无色溶液的物质。第二法适用于在第一法规定试验条件下不能产生澄清、无色溶液的物质，或者适用于由于性质复杂，易干扰硫化物离子与金属离子形成沉淀的物质，或者是不易挥发的和易挥发的油类物质。第三法为湿消化法，仅用于第一法、第二法都不适合的情况。特殊试剂特殊试剂特殊试剂特殊试剂硝酸铅贮备液—取硝酸铅159.8mg，溶于100ml水中，加1ml硝酸，用水稀释至1000ml。制备和贮存本溶液的玻璃容器应不含可溶性铅。标准铅溶液—使用当天，取硝酸铅贮备液10.0ml，用水稀释至100.0ml。每1ml的标准铅溶液含相当于10μg的铅。按每克供试品取100μl标准铅溶液制备的对照溶液，相当于供试品含百万分之一的铅。方法方法方法方法IIII pH3.5醋酸盐缓冲液—取醋酸铵25.0g溶于25ml水中，加6N盐酸液38.0ml，必要时，用6N氢氧化铵液或6N盐酸液调节pH至3.5，用水稀释至100ml，混匀。标准溶液准备—精密量取标准铅溶液2ml，（相当于20μg的Pb），置50ml比色管中，加水稀释至25ml，以精密pH试纸作为外指示剂，用1N醋酸液或6N 氢氧化铵液调节pH至3.0~4.0，用水稀释至40ml，混匀。供试品溶液制备—取各论项下规定的供试品溶液25ml，置50ml比色管中，或用各论项下规定用量的酸溶解样品，再用水稀释至25ml，供试品以g计，按下式计算： 2.0/（1000L）式中L是重金属限度（%）。以精密pH试纸作为外指示剂，用1N醋酸液或6N氢氧化铵液调节pH至3.0~4.0，用水稀释至40ml，摇匀。对照溶液制备—取供试品溶液制备项下的溶液25ml，置50ml比色管中，加标准铅溶液2.0ml，以精密pH试纸作为外指示剂，用1N 醋酸液或6N氢氧化铵液调节pH至3.0~4.0，用水稀释至40ml，摇匀。测定法—在上述三试管中，分别加入pH3.5的醋酸盐缓冲液2ml，然后再加硫代乙酰胺—甘油试液1.2ml，用水稀释至50ml，混匀，放置2分钟，在白色平面?自上向下观察：供试品溶液产生的颜色与标准品溶液产生的颜色相比，不得更深。对照溶液产生的颜色比标准溶液深或相当。[注意：如果对照溶液的颜色比标准溶液浅，用方法II代替方法I测定供试品]。方法方法方法方法IIIIIIII pH3.5醋酸盐缓冲液—按方法I配制。标准溶液准备—按方法I配制。供试品溶液制备—供试品以g计，按下式计算： 2.0/（1000L）式中L是重金属限度（%）。取供试品适量，称重，置适宜的坩埚中，加适量的硫酸使湿润，低温小心灼烧，直至全部炭化，（在炭化过程中坩埚不可盖严），加硝酸2ml和硫酸5滴至炭化物上，小心加热直到白烟不再逸出，置马富炉中500~600°灼烧，直至完全灰化，放冷，加6N盐酸液4ml，加盖，置蒸气浴上加热15分钟，去盖，在蒸汽浴上慢慢蒸发至干，用1滴盐酸湿润残渣，加热水10ml，蒸煮2分钟，滴加6N氢氧化铵液，直到溶液对石蕊试纸呈碱性，用水稀释至25ml，以精密pH试纸作为外指示剂，用1N醋酸液调节pH至3.0~4.0，必要时，滤过，用10ml水洗涤坩埚和滤器，合并滤液和洗液，置50ml比色管中，用水稀释至40ml，摇匀。测定法—在上述二试管中，分别加入pH3.5的醋酸盐缓冲液2ml，然后再加硫代乙酰胺—甘油试液1.2ml，用水稀释至50ml，混匀，放置2分钟，在白色平面?自上向下观察：供试品溶液产生的颜色与标准品溶液产生的颜色相比，不得更深。方法方法方法方法IIIIIIIIIIII pH3.5醋酸盐缓冲液——按方法I所示的方法配制。标准溶液的制备——取硫酸8mL和硝酸10mL的混合液，置洁净干燥的100mL凯氏烧瓶中，再加硝酸适量，加入量与供试品溶液中加入的硝酸量相当。加热使产生浓的白烟，冷却，小心加水10mL，若处理供试品需用过氧化氢，则加30%过氧化氢适量，加入量相当于供试品中消耗的过氧化氢量。缓缓煮沸至产生浓的白烟，再冷却，小心地加水5mL，混匀，缓缓煮沸至