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OXALIPLATIN 61825-94-3

EP7.2 , Medical Grade

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Product Detail

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.