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Oxaliplatin CAS:61825-94-3 EP standard with 99.5% up Oxaliplatin Antineoplastic API Oxaliplatin
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COA of Oxaliplatin |
TEST ITEM |
SPECIFICATION |
RESULTS |
Description |
White or almost white crystalline powder |
White crystalline powder |
Solubility |
Slightly soluble in water ,very slightly soluble in methanol, practically insoluble in ethanol |
Complies |
Identification |
A.The infrared absorption spectrum as the same as Oxaliplatin CRS B.Test for specific optical rotation |
A.Complies
B.Complies |
Apearance of solution |
The solution is clear and colourless |
Complies |
Acidity |
Not more than 0.6ml of 0.01M NaOH is required to change the colour of the indicator to pink |
Complies |
Specific optical rotation |
+74.5°~+78.0° |
+75.4° |
Related substances |
ImpurityA:NMT0.10% ImpurityB: NMT0.10% ImpurityC: NMT0.10% Any other impurity:NMT0.10% Total of other impurities: NMT0.10% (include impurity C) Total of impurities: NMT0.30% |
ImpurityA 0.01% ImpurityB:0.01% ImpurityC: 0.001% Any other impurities: 0.003% Total of other impurities: 0.01% Total of impurities: 0.03% |
Impurity D |
NMT0.10% |
N.D |
Silver |
NMT5.0ppm |
0.08ppm |
Loss on drying |
NMT0.5% |
0.09% |
Assay |
98.0~102.0% (dried substance) |
99.7% |
Bacterial endotoxins |
<1.0IU/mg |
Complies |
Total aerobic microbial count |
≤50cfu/g |
Complies |
Total combined yeasts and moulds count |
≤10cfu/g |
Complies |
Conclusion |
Complies with EP7.2. |
Usage |
Function of Oxaliplatin
Oxaliplatin is the third-generation platinum-based anticancer drug, a platinum compound of diaminocyclohexane, that is, a 1,2-diaminocyclohexane group is substituted for the amino group of cisplatin. It has the same effect as other platinum drugs, that is, it takes DNA as the target site of action, and platinum atoms form a cross-link with DNA to antagonize its replication and transcription. Combined application with fluorouracil (5-FU) has a synergistic effect; in vitro and in vivo studies have shown no cross-resistance with cisplatin. Oxaliplatin has a good effect on colorectal cancer and ovarian cancer, and has a certain effect on gastric cancer, non-Hodgkin's lymphoma, non-small cell lung cancer, and head and neck tumors. Colorectal cancer patients who are not effective for 5-FU treatment are still effective for other platinum-resistant patients.
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