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Test Item | Analysis Specification | Result |
Description | An orange yellow or yellow, | Conforms |
crystalline powder. | ||
Solubility | Insoluble in water, very soluble | Conforms |
in methanol, chloroform, freely | ||
soluble in anhydrous alcohol | ||
and ethyl acetate. | ||
E1%1cm | 458~486 | 460 |
Melting Range: | 52~55°C | 53.2-53.5°C |
Loss on drying | No more than 0.1% | 0.0003 |
Residue on ignition: | No more than 0.1% | 0.0003 |
Heavy metals | No more than 10ppm | Conforms |
Impurities(HPLC) | No more than 0.8% | 0.006 |
Residue Solvents (GC) | Hexane ≤ 0.029% | Conforms |
Methanol ≤ 0.3% | Conforms | |
Toluene ≤ 0.089% | Conforms | |
Assay(HPLC) | No less than 98.5% | 0.996 |
(on the dried Basis) | ||
Conclusion | Conform to Enterprise Standard |