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Products

Prophylactic Biological Products

97.5% up by HPLC, EP10.0, GMP Pemetrexed Disodium 150399-23-8

Category:

Prophylactic Biological Products

CAS NO:

150399-23-8

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

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Basic Info

CAS Number

150399-23-8

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

Product Information

Product name	Pemetrexed disodium
CAS No.	150399-23-8
Molecular Formula	C20H19N5Na2O6
Molecular Weight	471.374
Quality Standard	97.5% up by HPLC, GMP, EP10.0
Appearance	White powder

COA of Pemetrexed disodium

Items	Specifications	Results
Appearance:	White or almost white powder	Conform
Solubility	Freely soluble in water, very slightly soluble in anhydrous ethanol, practically insoluble in methylene chloride.	Conform
Identification	(1) IR: The IR spectrum is in accordance with that of reference	Conform
Identification	(2) Sodium salt: Positive	Positive
Appearance of solution	Not more opalescent than reference suspension II and not more intensely coloured than reference solution GY4	Conform
pH	7.5-8.4	8.1
Enantiomeric purity	NMT 0.3%	0.04%
Related substances
Impurity A	NMT 0.15%	0.03%
Impurity D	NMT 0.15%	0.01%
Individual impurity	NMT 0.10%	0.01%
Total impurities	NMT 0.6%	0.09%
Water	19.5%-22.1%	21.9%
Heavy metals	NMT 20ppm	< 20ppm
Residual solvents
Ethanol	NMT 5000ppm	742ppm
Acetone	NMT 5000ppm	ND
Dichloromethane	NMT 600ppm	ND
N-methyl morpholine	NMT 280ppm	ND
DMF	NMT 880ppm	ND
Microbial limits
TAMC	NMT 103 CFU/g	< 1x10 CFU/g
TYMC	NMT 102 CFU/g	< 1x10 CFU/g
Bacterial endotoxins	< 0.17EU/mg	< 0.17EU/mg
Assay (anhydrous basis)	97.5% - 102.0%	98.5%
Conclusion	Meet the specification of EP10.0