2013年9月24日星期二

Introduction of Vinblastine sulfate

Basic information:

English name: Vincristine Sulphate
English Synonyms: Vincristine Sulfate, Apocynaceae sp.; Vincristine Sulphate; Vincristine sulfate salt; 22-Oxovincaleukoblastine sulfate salt; Leurocristine sulfate salt 
Specification: 99%, pharmaceutical grade
Formula: 6H56N4O10.H2SO4
Purity: 99% min
Melting point: 273-281 ℃
Molecular Weight: 923.04 
CAS No. : 2068-78-2
Properties: white or white loose-like or amorphous solid, hygroscopic, easy to turn yellow when exposed to light or heat.

Characters:

Vinblastine sulfate is a white or almost white crystalline powder; odorless; hygroscopic; easy to turn yellow when exposed to light or heat. Vinblastine sulfate is soluble in water, soluble in methanol or chloroform, very slightly soluble in ethanol.

Inspection about Vinblastine sulfate:


Acidity detection: Take this product 10mg, dissolved in 10ml water, according to the determination (Appendix Ⅵ H), pH value should be 3.5 to 5.0.
Clarity of solution test: Take this chemical 10mg, dissolves into 5ml of water, the solution should be clarified.

Other alkaloids detection: Take Vinblastine sulfate, add methanol containing 10mg per 1ml of solution as the test solution; precise amount of the check amount, diluted with methanol to 0.20mg per 1ml of the solution, as a control solution. Thin layer chromatography (Appendix Ⅴ B) test, to learn the two solutions 5μl, respectively, in the same gel GF254 TLC plate with petroleum ether (boiling range 30 ~ 60 ℃) - chloroform - acetone - diethylamine (12:6:1:1) as the agent, started to dry, UV light (254nm), under review. The test solution were impurities such as spots, not more than two, the color control solution with the main spots, not deeper.

Loss on drying test: Take Vinblastine sulfate, phosphorus pentoxide as desiccant, at 80 ℃ vacuum drying to constant weight, less weight loss should not exceed 12.0% (Appendix Ⅷ L).

Identification about Vinblastine sulfate:


(1) Take this product 0.1mg, plus 1% sulfuric acid solution of ammonium cerium 1 to 2 drops, that was purple to dark purple.
(2) Take the determination of the solution, according to spectrophotometry (Appendix Ⅳ A) measured at 215 and 264nm wavelength of maximum absorption.
(3) The Vinblastine sulfate of the aqueous solution of sulphate of differential response (Appendix Ⅲ).

Classes and storage:


Vinblastine sulfate is an important antineoplastic agents. Preservation should pay attention to shading, sealed and refrigerated.


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