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Products

Prophylactic Biological Products

EP7.2 OXALIPLATIN 61825-94-3

Category:

Prophylactic Biological Products

CAS NO:

61825-94-3

Standard:

USP,BP,EP,JP,In-house Standards,

Price Range:

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Main Sales Markets:

North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East

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Sinoway Industrial Co. Ltd

Years

Show Room

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Basic Info

CAS Number

61825-94-3

Pharmacopoeia

USP,BP,EP,JP,In-house Standards

Grade

Pharmaceutical Grade

Is Manufacturer

YES

Packaging & Delivery

Packaging Specification

25kg/drum 1kg/bottle

Delivery Cycle

7 days after payment

Product Description

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.