Batch number

20220816

Manufacture date

2022.08.28

Batch size

200g

Test date

2022.09.10

quantity

188.96g

Report date

2022.09.20

Reference

USP

Retest date

2024.08.27

Items

Specification

Result

characters

Appearance

White or slightly yellowish.powder very hygroscopic.

White powder

Solubility

Freely soluble in water,soluble in methanol,slightly soluble in alcohol.

Conforms

Identification

A .infrared absorption

The IR spectrum of the substance to be examined corresponds to that of the Ph.Eur.reference spectrum of vincristine sulphate.

Conforms

B.Reaction of sulphate

Positive for sulphate

Positive

Tests

pH

3.5~4.5(1.0mg/ml in water)

4.5

Related substances

Other individual impurities:≤1.0%

0.41%

Total inpurity：≤4.0%

1.9%

Residual organic solvent

Methanol：≤3000ppm

64ppm

Ethanol ：≤5000ppm

2597ppm

Chloroform：≤600ppm

182ppm

Chloroform：≤60ppm

48ppm

Tetrahydrofuran：≤720ppm

5ppm

Loss on drying

≤12.0%

6.4%

Bacterial endotoxins

≤20EU/mg

Conforms

Microbial limit

Total viable acrobic count （acrobic bacteria plus fungi）：≤100CFU/g

10CFU/g

Psendomonas aeruginosa：Absence/g

Absence/g

Staphylococcus aurens：Absence/g

Absence/g

Enterobacteria：Absence/g

Absence/g

Assay

95.0%~104.0%（calculated with reference to the dried substance.）

98.0%