Function: | III Antiarrhythmic Drugs |
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Grade Standard: | Medicine Grade |
Type: | Chemical Reagent |
State: | Powder |
Volatile: | Not Volatile |
Standard: | Ep10.0. |
Samples: |
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Items | Specifications | Results |
Appearance | White or almost white,fine,crystalline powder | Almost white,fine, crystalline powder |
Solubility | Practically insoluble in water,freely soluble in methylene chloride,soluble in methanol,sparingly soluble in ethanol (96 percent). | Practically insoluble in water,freely soluble in methylene chloride,soluble in methanol,sparingly soluble in ethanol (96 percent). |
Identification | IR:Conforms to Amiodarone Hydrochloride CRS | Conforms to Amiodarone Hydrochloride CRS |
Chlorides:It gives reaction of chlorides | It gives reaction of chlorides | |
Appearance of Solution | The solution is clear | clear |
Not more than GY5 or BY5 | Less than GY5 | |
pH | 3.2 to 3.8 | 3.4 |
Melting Point | 158ºC~162ºC | 160.2ºC~161.3ºC |
Heavy Metals | Maximum 20ppm | Less than 20 ppm |
Loss on Drying | Maximum 0.5% | 0.05% |
Sulphated Ash | Maximum 0.1% | 0.02% |
Iodides | Maximum 150ppm | Less than 150ppm |
Impurity H | Not more than 0.02% | Less than 0.02% |
Related Substances | Impurity A:Not more than 0.2% | 0.04% |
Impurity B:Not more than 0.2% | 0.03% | |
Impurity C:Not more than 0.2% | 0.02% | |
Impurity D:Not more than 0.2% | ND | |
Impurity E:Not more than 0.2% | 0.03% | |
Impurity F:Not more than 0.2% | 0.006% | |
Impurity G:Not more than 0.2% | ND | |
Unspecified Impurities:Not more than 0.10% | 0.04% | |
Total Impurities:Not more than 0.5% | 0.18% | |
Residual Solvents | Ethanol:Not more than 5000ppm | 582ppm |
Toluene:Not more than 890ppm | 88ppm | |
Assay | 98.5% to 101.0%(dired substance) | 100.0% |
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