Basic Info.

Model NO.

SAMREAL-0169

Trademark

samreal

Origin

China

Model NO.

SAMREAL-0169

Trademark

samreal

Origin

China

Product Desciption

Oxaliplatin CAS No 63121-00-6

According to	EP9.0
Items	Standard	Results
Appearance	White or almost white crystalline powder	white crystalline powder
Solubility	Slighly soluble in water,very slightly soluble in methanol,practically insoluble in anhydrous ethanol	conforms
Identification	Spectrum of sample should be consistent with spectrum of reference standard Specific optical rotation(see Tests)	Conforms conforms
Appearance of Solution	The solution is clear and colorless	conforms
Acidity	Dissolve 0.10g in carbon dioxide-free water R,dilute to 50ml with the same solvent and add 0.5ml of phenolphthalein solution R1 ,the solution is colourless.Not more than 0.6ml of 0.01M sodium hydroxide is required to change the colour of the indicator to pink	conform
Specific optical rotation(20ºC)	+74.5°~+78.0°(dried substance)	+75.9°
Impurity D	≤0.10%	N.D
Related substances	Impurity A≤0.10% Impurity B≤0.10% Impurity C≤0.10% Impurity C:Any other impurity≤0.10% Impurity C:Total of other impurities≤0.10% Total of impurities≤0.30%	0.01% 0.01% 0.001% 0.003% 0.01% 0.03%
Silver	≤5.0ppm	<1ppm
Loss on drying	≤0.5%	0.10%
Bacterial endotoxins	<1.0IU/mg(1.0EU/mg)	<1.0IU/mg(1.0EU/mg)
Residual solvent	Alcohol ≤0.5%	N.D
Assay	98.0%~102.0%(dired substance)	99.6%

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