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Ceftriaxone Sodium - 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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      Ceftriaxone Sodium

      CAS number: 74578-69-1

      Molecular formula: C18H16N8Na2O7S3

      molecular weight: 598.5436

      Chemical structure:

      Details

      Product Name PHARMACEUTICAL ALLOPATHIC RAW MATERIAL FOR INDUSTRY Ceftriaxone Sodium Sterile USP 
      Shelf life
      3 years
      TEST ITEMS SPECIFICATION RESULT
      Description white to yellowish-organge crystlline powder. Almost white crystalline powder
      Identification

      By IR Meets the requirements. Complies
      By HPLC Meets the requirements. Complies
      Tests for sodium It gives reaction of sodium Positive
      Test

      Crystallinity Meets the requirements. Complies
      pH 6.0~8.0 6.5
      Impurity A Deacetylcetotaxime lactone≤0.5% Not Detected
      Impurity B,C 7-Aminocephalosporanic acid≤0.5% 0.01%
      Impurity D Ceftriaxone triazine analog≤1.0% 0.09%
      Impurity E Ceftriaxone benzathiazoly oxime≤0.2% Not Detected
      Impurity F Deacyl ceftriaxone≤0.5% 0.07%
      Impurity G Ceftriaxone 3-ene isomer≤0.3% Not Detected
      Impurity H Ceftriaxone E-isomer≤0.5% 0.02%
      Any individual ≤0.2% 0.04%
      Unknown impurity

      Total impurities ≤2.5% 0.3%
      Water(By KF) 8.0%~11.0% 9.3%
      Methanol ≤0.3% Not Detected
      ≤0.5% Not Detected
      ≤0.041% Not Detected
      ≤0.5% Not Detected
      ≤0.06% Not Detected
      ≤0.5% Not Detected

      Partieless≥10μg/mg:NMT 6000 part/g

      660
      Partieless≥25μg/mg:NMT 600 part/g
      <0.20EU/mg Complies
      It complies with the test for sterlity Complies
      Informative 0.54g/ml
      Informative 0.72g/ml
      ASSAY

      Ceftriaxone on anhydrous basis 795μg/mg 932μg/mg
      Storage Condition Preserve in airtight,tamper-proof container;in a dry place at a temperature not exceeding 20℃.
      RESULT: THE RESULT CONFORMS TO USP38、QS-CO11014(USP)-01.