oxaliplatino EP/USP Pharmaceutical API Drug treatment of colorectal cancer made in china CAS NO.61825-94-3

appearance

white or almost white crystalline powder.

solubility

slightly soluble in water, very slightly soluble in

methanol, practically insoluble in ethanol.

identification

a. infrared absorption spectrum

b. it complies with the test for specific optical rotation (see tests).

appearance of solution

the solution is clear and colourless.

acidity

the solution is colorless, and nmt 0.6ml of 0.01m sodium hydroxide is required to change the color to pink.

specific optical rotation

+74.5°～+78.0°

content of platinum

48.1%～50.1% of the oxaliplatin taken, on the dried basis

related substances

impurity a≤0.1%

impurity b≤0.1%

impurity c≤0.1%

any other impurity ≤0.1%

total of other impurities ≤0.1%

total impurities(the sum of impurities a, b, c and

other related impurities) ≤0.30%

impurity d≤0.1%

silver

≤5.0ppm

loss on drying

≤0.5%

bacterial endotoxins test

≤1.0iu/mg of oxaliplatin

assay

98.0 per cent to 102.0 per cent (dried substance).

microbial enumeration tests and tests and for specified microorganisms

total aerobic microbial count ≤20cfu/g

total combined molds and yeast count≤5cfu/g