Pemetrexed Disodium
DMF under preparing
GMP certificated
CAS 150399-23-8
Molecular Formula: C20H19N5Na2O6
Character: white or white crystalline powder; odorless,tasteless, easily absorb water;
Solubility: freely soluble In Water,practically insoluble In chloroform, slightly soluable in Methanol;
Identification: (1)flame reaction with sodium salt;(2)The reaction time in the chromatogram of the assay preparation coorresponds to that in the chromatogram of the standard preparation, as obtained in the assay;(3)IR: should conform to the standard;PH: 6.5-8.0;Clear and color of solution:should conform to standard;
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Test Items
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Standard
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Test Results
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Character
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Almost-white or light yellow unfixed powder, smell-less, hygroscopic freely.
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white unfixed powder, smell-less, hygroscopic freely.
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Solubility
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Soluble in water very freely, in ethanol or chloroform or ethyl ether hardly.
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Conforms
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Specific optical rotation
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+10°－+16°
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+11.6°
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Identification
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(1)The product appears flame reaction of sodium salt.
(2)UV:Max absorption at 225nm wavelength.
(3)IR:Meet the requirements.
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Conform
Conform
Meet the requirements.
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PH
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6.5－8.0
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7.6
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Clarity and color of solution
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Meet the requirements.
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Conforms
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Related substance
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Max single impurity≤0.1%
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0.08%
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Total impurity≤0.5%
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0.30%
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Optical isomer
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≤0.500%
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0.12%
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Heavy Metal
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<20ppm
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Conforms
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ethanol
Dichloromethane ethyl acetate
DMF
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≤0.500%
≤0.060%
≤0.500%
≤0.088%
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0.005%
0.003%
0.001%
0.004%
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Water
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7.2%－10.2%
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9.5%
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Assay
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Not less than 98.50%, calculated on the anhydrous basis.
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99.70%
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