Customization: | Available |
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Function: | Cardiovascular Agents |
Certification: | GMP |
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Check Item | Standard Regulation | |
Appearance | Appearance | White or almost white crystalline powder. |
Solubility | Very soluble in water and ethanol, soluble in chloroform, insoluble in ether. | |
Identification | Color reaction | To about 5mg add 0.5ml of fuming nitric acid. Evaporate to dryness on a water-bath, cool and dissolve the residue in 5ml of acetone add 0.2ml of alcoholic potassium hydroxide solution a green colour is produced. |
Infrared Absorption |
The infrared absorption spectrum of the sample shall be consistent with that of the reference substance. |
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Chloride Identification |
Conforms of Chloride reaction | |
Analysis | Sulfate | Not more than 0.1% |
Water | 5.0%-7.0% | |
Sulfated ash | Not more than 0.1% | |
Organic impurities |
Impurity A: not more than 0.01% | |
Impurity H: not more than 0.1% | ||
Unspecified single impurity: not more than 0.10% | ||
Total impurities: not more than 0.5% | ||
Bacterial Endotoxin | Less than 0.5EU/mg | |
Assay | NLT 97.5% and NMT 102.5%, calculated on the anhydrous basis. |