[Offer to Sell] sell Epirubicin HCL |
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| Appearance Orange-red powder Solubility Soluble in water and in methanol, slightly soluble in ethanol, and practically insoluble in acetone Identification A. IR spectrum concordant with standard reference spectrum B. Retention time of principle peak in the HPLC chromatogram, similar to that obtained with stander. C. Test for Chloride PH 4.0-5.5 w/w(0.5% w/v solution) Related Substances(HPLC) doxorubicinone ≤1.0%(IMP.A) doxorubicin hydrochloride ≤1.0%(IMP.C) Any other impurity ≤0.5% Total impurities ≤2.0% Acetone ≤ 1.5% w/w Water ≤4.0% w/w Assay(HPLC) 97% ~ 102% ( on anhybrous and solvent free basis) Residue solvent Methanol: max.3000ppm Ethanol:max.5000ppm Acetone: max 5000ppm Acetondride: max410ppm Dichloromethane: max.500ppm a-heonene:max.20ppm Diseropyl ether: max.5000ppm Ethyl acetate: max.5000ppm Chloroform: max.50ppm Bencone: max 2ppm 1.4-dioxare: max.380ppm Total: max.5000ppm |
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