Powder: | Yes |
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Customized: | Non-Customized |
Certification: | GMP, ISO 9001, USP, BP |
Suitable for: | Elderly, Children, Adult |
State: | Solid |
Purity: | >99% |
Customization: |
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Item | Acceptance criteria | Result |
Appearance | White or almost white powder | White powder |
Solubility | Freely soluble in anhydrous ethanol and in methanol, slightly soluble in acetone, very slightly or slightly soluble in water. | Conforms |
Identification | IR absorption spectrum of sample should be consistent with spectrum of standard | Consistent with spectrum of standard |
It gives reaction (a) of chlorides using anhydrous ethanol as solvent | Forward reaction | |
Related substances |
B (Impurity B) W0. 15% | N.D |
E (Impurity E) W0. 05% | N.D | |
(Unspecified impurity) W0. 10% | 0.03% | |
(Total impurities) W0. 3% | 0.09% | |
Loss on drying | W0. 5% | 0.08% |
Sulfated ash | W0. 1% | 0.04% |
Residual solvents | (Isopropyl alcohol) W5000ppm | 94ppm |
(Ethyl acetate) W5000ppm | 116ppm | |
(Trichloromethane) W60ppm | 20ppm | |
Assay | 99.0%-101.0% (Calculated on the dried basis) | 99.70% |
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