Roxithromycin EP/BP /CPsupplier Pharmaceutical API Antibiotic CAS NO.80214-83-1

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 

1. HPLC：similar in rotation time to the principal peak of the reference
2. IR: conforms to the reference spectrum

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