Oxaliplatin 61825-94-3 Oxaliplatin supplier
Test Items |
Specifications |
Appearance |
White to off-white crystalline power |
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 |
|
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. |
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