China Clarithromycin API with GMP CAS No 81103-11-9

Clarithromycin is an acid stable macrolide antibiotic indicated for use in the treatment of skin, urinary and respiratory tract infections. Compared to erythromycin, clarithromycin exhibits the same in vitro activity against conventional pathogens, but is better tolerated by generating less gastrointestinal problems.

The items and results of InspectionItemsSpecificationTest resultsAppearance

White to off-white, crystalline powder.

Soluble in acetone;

slightly soluble indehydrated alcohol,

in methanol, and inacetonitrile,

and in phosphate buffer at pH values of 2 to 5;

practically insoluble in water.

ConformsSolubilityConformsIdentification Infrared absorptionCorresponds to RS.ConformsOptical rotation-94°~-102°-98°CrystallinityMeets the requirementConformspH8.0- 10.09Water≤2.0%1.1%Related substances (HPLC) Clarithromycin impurity I≤1.0%N.D.Clarithromycin impurity A≤1.0%N.D.Clarithromycin impurity J≤1.0%N.D.Clarithromycin impurity L≤1.0%N.D.Clarithromycin impurity B≤1.0%N.D.Clarithromycin impurity M≤1.0%N.D.Clarithromycin impurity C≤1.0%N.D.Clarithromycin impurity D≤1.0%0.2%Clarithromycin impurity N≤1.0%N.D.Clarithromycin related compound A≤1.0%0.7%Clarithromycin impurity F≤1.0%0.4%Clarithromycin impurity P≤1.0%N.D.Clarithromycin impurity O≤1.0%N.D.Clarithromycin impurity K≤1.0%N.D.Clarithromycin impurity G≤1.0%0.09%Clarithromycin impurity H≤1.0%N.D.Impurities exceed 0.4%≤42Total impurity≤3.5%3.1%Residue on ignition≤0.2%0.04%Assay (HPLC, on anhydrous basis)96.0~ 102.0%98.4%Additional test: Residual solvent (GC)-Ethanol≤5000 ppm744 ppm