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Rimantadine 1-(1-Adamantyl)ethanamine alpha-Methyladamantanemethylamine
Item | Standard | |||||
Description | Yellowish crystalline powder | |||||
Identification | Corresponds to the IR spectrum of standard | |||||
Specific Rotation | -92°~-99° | |||||
Clarity of solution |
Clear or its opalescence is not more pronounced than that of reference suspension
|
|||||
UV absorbance | Not more than 0.05 | |||||
Heavy metals | Not more than 20ppm | |||||
Water | 2.0-3.0% | |||||
Residue on ignition | Not more than 0.1% | |||||
PH | 6.8-7.6 | |||||
Related substance | ||||||
Impurity B | Not more than 0.2% | |||||
Impurity C | Not more than 0.2% | |||||
Sum of impurities | Not more than 1.0% | |||||
R-ofloxacin | Not more than 1.0% | |||||
Assay | 98.0%~102.0% | |||||
Conclusion: Conform. |
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