Current API product portfolio
AciclovirSpecification:
|
|
| chemical name: | 2-amino-9-[(2-hydroxyethoxy)methyl]-1,9-dihydro-6H-purin-6-one |
| molecular formula: | C8H11N5O3 |
| molecular weight: | 225.2 |
| CAS Registery number: | 59277-89-3 |
General information: White to off-white, crystalline powder. Melts at temperatures higher than 250 °C, with decomposition. Soluble in diluted hydrochloric acid; slightly soluble in water; insoluble in alcohol. |
|
| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| Identification: A. IR spectrum B. HPLC |
corresponds to reference substance spectrum retention time of mean peak in the test solution chromatogram correspond to retention time of mean peak in the reference solution chromatogram |
USP |
| Water | not more than 6.0% | USP |
| Related substances: - sum of impurities |
not more than 1% | USP |
| Residual solvents: - toluen - methanol - ethanol |
not more than 200 ppm not more than 600 ppm not more than 1000 ppm |
USP |
| Content of guanine | not more than 0.7% | USP |
| Content of acyclovir calculated on anhydrous substance | 98.0% - 101.0% | USP |
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