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COA:
Name of product |
Pemetrexed Disodium hemipenta hydrate |
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Net weight |
5kg |
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Date of manufacture |
Otc. 20, 2014 |
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Expiry Date |
Otc. 19, 2016 |
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Test Items |
Standard |
Test Results |
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Character |
Almost-white light yellow unfixed powder, smell-less, hygroscopic freely. |
white unfixed powder, smell-less, hygroscopic freely. |
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Solubility |
Soluble in water very freely, hardly soluble in ethanol chloroform ethyl ether. |
Conformed |
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Specific optical rotation |
+10°-+16° |
+12.0° |
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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. |
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PH |
6.5-8.5 |
7.2 |
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Clarity colof solution |
Meet the requirements. |
Conforms |
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Related substance |
Max single impurity≤0.1% |
0.036% |
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Total impurity≤0.5% |
0.17% |
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Purity |
≥99.5% |
99.83% |
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Assay |
Not less than 98.50%, calculated on the anhydrous basis. |
99.10% |
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Storage:Preserve in tight, light-resistant containers, keep from light, in a cold place, under 2-8℃ |
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