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Product name | Tenofovir Alafenamide fumarate | |
CAS No.: | 1392275-56-7 | |
Items | Specifications | |
Description | Appearance | A white to off-white or tan, slightly hygroscopic powder |
Solubility | In aqueous media, it is soluble at low pH(pH 2.0),sparingly soluble at pH 3.8, and slightly soluble at pH values up to 8.0. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in isopropanol and slightly soluble in acetone. | |
Identification | IR: | The IR absorption spectrum of the sample must be concordant with Test Standard |
HPLC: | The retention time of the major peak in the chromatogram conforms to the characteristic peak of R.S. | |
Loss On Drying | Not more than 1.0% 0.35% | |
Related Substances | Any other impurity: | Not more than 0.3% |
Total impurities: | Not more than 1.0% | |
Residual Solvents | Meets current ICH requirements | |
Assay (on anhydrous basis) | 98.0%-102.0% |
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