| Product description : |
Items Specifications Results
Characters
Appearance White or almost white, fine crystalline powder conforms
Solubility Very slightly soluble in water, freely soluble in methylene chloride, soluble methanol, sparingly soluble in ethanol(96%) conforms
Identification
A) IR Conforms to Amiodarone Hydrochloride CRS Conforms
B) Chlorides It gives reactions of chlorides Conforms
Appearance of solution clear, NMT GY5 Conforms
Melting Range 159~163°C 159.0~160.0°C
pH 3.2~3.8 3.63
Impurity H (by TLC) NMT 0.02% <0.02%
Related Substance (by HPLC )
Impurity A NMT 0.20% 0.07%
Impurity B NMT 0.20% 0.10%
Impurity C NMT 0.20% conforms
Impurity D NMT 0.20% 0.05%
Impurity E NMT 0.20% 0.03%
Impurity F NMT 0.20% conforms
Impurity G NMT 0.20% 0.01%
Unspecified impurities NMT 0.20% 0.02%
Total impurities NMT 0.20% 0.34%
Iodides NMT 150ppm <150ppm
Heavy metals NMT 20ppm <20ppm
Loss on drying NMT 0.5% 0.08%
Sulphated ash NMT 0.1% 0.02%
Assay 98.5%~101.0% 100.00%
Residual Solvents
Ethanol NMT5000ppm 782ppm
Toluene NMT890ppm 94ppm
Conclusion The results can conforms with the EP6 |
