Oxaliplatin CAS NO.61825-94-3

Test Items	Specifications
Appearance	White to off-white crystalline power
Identification	IR spectrum The retention time of the major peak in the sample solution corresponds to that in the standard solution, as obtained in the Assay.
Identification
Acidity	The solution is colorless, and NMT 0.6ml of 0.01M sodium hydroxide is required to change the color to pink.
Loss on drying	≤0.5%
Optical rotation	+74.5°~+78.0°
Limit of Silver	≤5ppm
Heavy Metals	≤20ppm
Content of Platinum	48.1%~50.1% of the Oxaliplatin taken, on the dried basis
Limit of Oxalic acid	≤0.1%
Limit of (SP-4-2)-Diaqua[(1R, 2R)-Cyclohexane-1, 2-Diamine-N, N^’]platinum, Oxaliplatin Related compound C and unspecified impurities	(SP-4-2)-Diaqua[(1R, 2R)-Cyclohexane-1, 2-Diamine-N, N^’]platinum≤0.1%
	Oxaliplatin Related compound C≤0.1%
	Diaquodiaquamino cyclohexane platinum dimer ≤0.1%
	Any individual unspecified impurity≤0.10%
	Total impurities≤0.30%
Limit of Oxaliplatin related compound D	≤0.1%
Assay	Not less than 98.0%~102.0% of C₈H₁₄N₂O₄Pt, calculated on the dried basis.
Bacterial Endotoxins Test	≤1.0EU/mg of Oxaliplatin
Microbial Enumeration Tests and Tests for Specified Microorganisms	Total aerobic microbial count≤20CFU/g
	Total combined molds and yeast count ≤5CFU/g
Packaging and storage: Keep in tight containers, protected from light.

Test Items	Specifications
Appearance	White to off-white crystalline power
Identification	IR spectrum The retention time of the major peak in the sample solution corresponds to that in the standard solution, as obtained in the Assay.
Identification
Acidity	The solution is colorless, and NMT 0.6ml of 0.01M sodium hydroxide is required to change the color to pink.
Loss on drying	≤0.5%
Optical rotation	+74.5°~+78.0°
Limit of Silver	≤5ppm
Heavy Metals	≤20ppm
Content of Platinum	48.1%~50.1% of the Oxaliplatin taken, on the dried basis
Limit of Oxalic acid	≤0.1%
Limit of (SP-4-2)-Diaqua[(1R, 2R)-Cyclohexane-1, 2-Diamine-N, N^’]platinum, Oxaliplatin Related compound C and unspecified impurities	(SP-4-2)-Diaqua[(1R, 2R)-Cyclohexane-1, 2-Diamine-N, N^’]platinum≤0.1%
	Oxaliplatin Related compound C≤0.1%
	Diaquodiaquamino cyclohexane platinum dimer ≤0.1%
	Any individual unspecified impurity≤0.10%
	Total impurities≤0.30%
Limit of Oxaliplatin related compound D	≤0.1%
Assay	Not less than 98.0%~102.0% of C₈H₁₄N₂O₄Pt, calculated on the dried basis.
Bacterial Endotoxins Test	≤1.0EU/mg of Oxaliplatin
Microbial Enumeration Tests and Tests for Specified Microorganisms	Total aerobic microbial count≤20CFU/g
	Total combined molds and yeast count ≤5CFU/g
Packaging and storage: Keep in tight containers, protected from light.