Darunavir API
≥98.0%
Darunavir
Appearance |
White to off-white crystalline powder |
|
Identification |
||
a. IR spectrometry |
Corresponds to the standard spectrum |
|
b. 1H NMR |
Corresponds to the standard spectrum |
|
Related Substances |
Max single impurity ≤ 0.5% Total impurities ≤ 1.0% |
|
Residue on ignition |
≤ 0.1% |
|
Heavy metals |
≤10ppm |
|
Water Value |
≤1.0% |
|
Optical rotation |
-5.0°~ 0° |
|
Assay |
≥98.5% ( on dry basis) |
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