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Ibuprofen - 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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      Ibuprofen

      CAS number: 15687-27-1;58560-75-1

      Molecular formula: C13H18O2

      molecular weight: 206.2734

      Chemical structure:

      Details

      Product Name: Ibuprofen
      Shelf Life: 4 years
      Items Specifications Results
      Description White or off-white powder Conforms
      Identification a)IR Spectrum :Must Comply Conforms
      b)HPLC: Retention Time Must Comply Conforms
      Optical Rotation -0.10o— +0.10o +0.00o
      Clarity of Solution a)1% Solution in water: Clear Conforms
      b)1% Solution in methanol: Clear Conforms

       

      Ibuprofen Related  Substances(by HPLC) a) 2-(4-butylphenyl) propionic acid: Not detected
      Not More Than 0.1%(area%)
      b) Any other individual Impurity: 0.04%
      Not More Than 0.1%(area%)
      c)Total Impurity: 0.07%
      Not More Than 0.3%(area%)
      Lysine Related Substances(by TLC) Any maximum impurity: Not more than0.1% Conforms
      pH pH of 1% aqueous solution:6.2-7.0 6.59
      Heavy Metals Not More Than 10ppm <10ppm
      Residue on ignition Not More Than 0.1% 0.01%

       

      Water Not More Than 0.5% 0.16%
      Assay a)Lysine content (by titration): 100%
      98.5-101.5%
      b) Ibuprofen content (by HPLC): 100.3%
      98.5-101.5%
      Residual Solvents(by GC) Ethanol: Not More Than 1000ppm 22ppm
      Conclusion: The product meets the above specifications.