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Clarithromycin - Antibiotics - 鹽城鳴遠藥業有限公司、鳴遠藥業、鳴遠藥業有限公司、鹽城鳴遠藥業
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      Clarithromycin

      CAS number: 81103-11-9

      Molecular formula: C38H69NO13

      molecular weight: 747.9534

      Chemical structure:

      Details

      PRODUCT NAME CLARITHROMYCIN
      Shelf Life
      4 years
      ITEMS SPECIFICATIONS RESULTS
      APPEARANCE WHITE TO ALMOST WHITE,CRYSTALLINE POWDER COMPLIES
      SPECIFIC ROTATION -94° TO -102°(20) -96.9°
      IDENTIFICATION IR SPECTRUM CORRESPONDS TO COMPLIES
      CRYSTALLINITY MEETS THE REQUIREMENTS COMPLIES
      PH 8.0-10.0 8.4
      WATER NOT MORE THAN 2.0% 0.3%
      RESIDUE ON IGNITION NOT MORE THAN 0.2% 0.02%
      HEAVY METALS NOT MORE THAN 20UG/G COMPLIES
      PARTICLE SIZE 40MESHES COMPLIES
      RESIDUAL SOLVENTS ETHANOL NOT MORE THAN 5000PPM 300PPM
      PYRIDINE HYDROCHLORIDE SHOULD NOT DETECTED ND
      RELATED SUBSTANCES IMPURITY I NOT MORE THAN 1.0% 
      ND
      IMPURITY A NOT MORE THAN 1.0% 
      ND
      IMPURITY J NOT MORE THAN 1.0% ND
      IMPURITY L NOT MORE THAN 1.0% ND
      IMPURITY B NOT MORE THAN 1.0% ND
      IMPURITY M NOT MORE THAN 1.0% 0.06%
      IMPURITY C NOT MORE THAN 1.0% ND
      IMPURITY D NOT MORE THAN 1.0% ND
      IMPURITY N NOT MORE THAN 1.0% ND
      RELATED COMPOUND A NOT MORE THAN 1.0%
      ND
      IMPURITY F NOT MORE THAN 1.0% 0.27%
      IMPURITY P NOT MORE THAN 1.0% ND
      IMPURITY O NOT MORE THAN 1.0% ND
      IMPURITY K NOT MORE THAN 1.0% ND
      IMPURITY G NOT MORE THAN 1.0% ND
      IMPURITY H NOT MORE THAN 1.0% ND
      Any individual impurity not more than 1.0% 0.6%
      Impurity exceed 0.4% not more than 4
      2
      Total impurities not more than 3.5%
      2.8%
      ASSAY 96.0---102.0% ON ANHYDROUS BASIS 97.7%
      CONCLUSION THIS BATCH OF PRODUCT IS IN CONFORMANCE WITH USP38