Vincristine Sulphate/ 2068-78-2

Vincristine sulfate

Subjects

Vincristine sulfate

Specifications

Results

Characters

Appearance

White or almost white powder

White powder

Solubility

Freely soluble in water and in methanol , practically insoluble in hexane

Conform

Identification

A. Infrared Absorption

ir spectrum of the sample corresponds to that of the ref standard

Conform

B.HPLC

The retention time of the major peak in the chromatograms corresponds to that in the reference standard

Conform

c. Tartrate Reaction

Positive for tartrate

Conform

Test

Clarity of solution

Clear solution(140mg/10ml water)

Clear solution

Color of solution

Absorbance at 420nm NMT0.03

(1.4%W/V solution in water)

0.003

PH

3.3~3.8

3.5

Water

Not more than 4.0%

2.3%

Residue on ignition

Not more than 0.1

Conform

Heavy metals

Not more than 20ppm

NMT 10ppm

Boron

Not more than 50ppm

Conform

Fluorides

Not more than 50ppm

Conform

Silver

Not more than 5ppm

Conform

Related

Compounds

Impurity A

Not more than 0.3%

0.04%

Any other impurity

Not more than 0.2%

0.10%

Sum of impurities other than A

Not more than 0.7%

0.23%

Residual

Organic solvent

1. Chloroform

Not more than 0.005%

0.003%

1. Methylence Chloride

Not more than 0.01%

0.004%

1. Acetone

Not more than 0.5%

0.33%

1. Ether

Not more than 0.5%

0.05%

1. Methanol

Not more than 0.3%

0.06%

1. Hexance

Not more than 0.029%

0.008%

1. Tetrahdrofuran

Not more than 0.072%

0.011%

Bacterial endotoxins

Not more than 2EU/mg

Conform

Microbiological purity( bactenas and mould)

Not more than 100 CFU/g

Conform

Enterobacteriaceae

Not detected

Not detected

Pseudomonas aeruginosa

Not detected

Not detected

Staphylococcus aureus

Not detected

Not detected

Assay

98.0%~102.0%(On the anhydrous basis)

99.8%

Conclusion

All standards comply with EP6.0