Фармацевтическая компания Pemetrexed поставщик порошка динатрия

Test Items

Standard

Test Results

Character

Almost-white or light yellow unfixed powder,smell-less,hygroscopic freely.

white unfixed powder,smell-less,hygroscopic freely.

Solubility

Soluble in water very freely,in ethanol or chloroform or ethyl ether hardly.

Conform

Specific optical rotation

+10°-+16°

+11.4°

Identification

(1)The product appears flame reaction of sodium salt.

(2)UV:Max absorption at 225nm wavelength.

(3)IR:Meet the requirements.

Conform

Conform

Meet the requirements.

PH value

6.5-8.0

7.78

Clarity and color of solution

Meet the requirements.

Conform

Related substance

Max single impurity≤0.1%

0.08%

Total impurity≤1.0%

0.3%

Optical isomer

≤0.500%

0.13%

Heavy Metal

<20ppm

Conforms

ethanol

Dichloromethane ethyl acetate

DMF

≤0.500%

≤0.060%

≤0.500%

≤0.088%

0.005%

0.003%

0.001%

0.004%

Water

19.5%~22.5%

20.5%

Assay

Not less than 98.50%,calculated on the anhydrous basis.

99.7%