杂质标准品分析证书(示例)

Date of shipment: 2012-May-31

This certificate is valid for two years from the date of shipment

provided the substance is stored under the recommended conditions.

I. Identity

The identity of the reference substance was established by following analyses.

Ia. 1H-NMR Spectrum

Conditions: 400 MHz, DMSO-d6

The structure is confirmed with the signals of the spectrum and their interpretation.

Ib. IR Spectrum

Method: Attenuated Total Reflection Fourier Transform Infrared (ATR-FTIR) Spectroscopy

The signals of the IR spectrum and their interpretation are consistent with the structural formula.

II. Purity

The purity of the reference substance was analysed by high performance liquid chromatography (HPLC).

HPLC Conditions:

Column:Conditions:Detector:Injector:

Hypersil Gold (C18) 1.0 ml/min, 40 °C DAD Auto

5 μm, 150 x 4.

6 mm 0-8 min Water/Acetonitrile 45/55

8-15 min Water/Acetonitrile to 20/80

15-20 min Water/Acetonitrile to 45/55

20-30 min Water/Acetonitrile 45/55 (v/v);

0.1 % H3PO4220 nm 3.5 μl; 0.0502 mg/ml in

Water/Acetonitrile 50/50 (v/v)

Results:

Average 99.90 % Number of results n=6 Standard deviation 0.01 %

III. Water Content

Method: Karl Fischer titration

No significant amounts of water were detected (< 0.05 %).

IV. Residual Solvents

Method: 1H-NMR

No significant amounts of residual solvents were detected (< 0.05 %).

V. Final Result

Total impurities (HPLC) 0.10 %

Water content n. d. (not detected)

Residual solvents n. d. (not detected)

Assay (100 % method) 99.90 %

The assay is assessed to be 99.9 % ‘as is’

The assay 'as is' is equivalent to the assay based on the not anhydrous and not dried substance respectively.

Release Date: 2011-04-14 LGC GmbH

Dr. Sabine Schr?der

Product Release