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1 Kilogram |
Negotiable |
Roxithromycin Roxithromycin EP Roxithromycin BP
EP/BP/CP
Roxithromycin
Characteristics |
White or almost white crystalline powder,odorless,bitter,slightly hygroscopicity |
Solubility |
Practically insoluble in water,freely soluble in ethanol or acetone,soluble in methanol |
Specific optical rotation |
-82° to -87° |
Identification |
|
PH |
8.0-10.0 |
Related substances |
Any single impurity≤1.0% Total impurities≤4.0% |
Water |
≤3.0% |
Residue on ignition |
≤0.1% |
Heavy metals |
≤10ppm |
Assay (HPLC) |
≥94.0% of C41H76N2O15 (anhydrous suastance) |
Residual solvents |
Methanol ≤3000ppm |
|
Acetone ≤5000ppm |
|
N,N-Dimethylformamide≤880ppm |
|
Dichloromethane ≤600ppm |
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