Item | Standard | Test Results |
Appearance | Light-yellow to white crystalline powder | Off-white crystalline powder |
Specific Rotation (on dried basis, 5% solution in methanol) | +4.0°~+8.0° | +7.42° |
Identification | HPLC/UV | Complies |
Related Substances | Total impurities: NMT 1.0% Maximum single impurity: NMT 0.5% | 0.93% 0.47% |
Loss on Drying (Dry it at 105°C in an electric air blowing dryer till a constant weight) | Not more than 1.0% | 0.14% |
Residue on Ignition | Not more than 0.1% | 0.07% |
Heavy Metal | Not more than 20ppm | Less than 20ppm |
Assay(on dried basis) | Not less than 98.5% | 99.49% |
Function
Bepotastine besilate is an inhibitor of Histamine H1 Receptor
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