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_Paracetamol - Antibiotics - 鹽城鳴遠藥業(yè)有限公司、鳴遠藥業(yè)、鳴遠藥業(yè)有限公司、鹽城鳴遠藥業(yè)
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      Paracetamol

      CAS number: 103-90-2

      Molecular formula:

      molecular weight:

      Chemical structure:

      Details

      Product Name Paracetamol  
      Shel Life 3 years  
      Tests Specification Results
      Appearance White or almost free flowing granules White free flowing granules
      Identification
      A:The IR spectra of the sample compares to that of the standard
      Positive
      B:The retention times of the major peaks from the sample solution correspond to those from the standard solution, as obtained in the Assay Positive
      Water 0.6%-1.5% 0.72%
      Bulk density 0.40-0.60 g/ml 0.48g/ml
      Tapped density 0.50-0.69g/ml 0.59g/ml
      Organic impurities Related compound B N- (4-HydroxyphenyI) propanamide not more than 0.05% 0.02%
      Related compound C N- (2-HydroxyphenyI)  acetamide not more than 0.05% 0.004%
      Related compound D (N-Phenylacetamide) not more than 0.05% 0.0003%
      Related compound J N-(4-ChlorophenyI) acetamide (p-chloroacetanilide) not more than 0.001% Not detected
      Individual unspecified impurity not more than 0.05% 0.007%
      Total impurities not more than 0.1% 0.04%
      Free p-aminophenol Not more than 0.005% 0.0003%
      Particle size(sieve) Retained on US No.60: NMT 25.0% 22.8%
      Retained on US No.100: NMT 70.0% 57.5%
      Retained on US No.200: NMT 95.0% 84.3%
      Retained on US No.325: NLT 80.0% 95.6%
      Residue on ignition Not more than 0.14% 0.07%
      Heavy metals Not more than 0.001% Less than 0.001%
      Assay(anhydrous basis) 87.5%92.5% 90.0%
      Microbial limits Total aerobic microbial count not more than 1000cfu/g Less than 10cfu/g
      Total combined molds and yeasts count not more than 100cfu/g Less than 10cfu/g
      Escherichia coli should be absent Not detected
      Salmonella should be abent
      Not detected
      Residual solvents Not applicable as no solvents are used in the manufacturing process of PARACETAMOL ( ACETAMINOPHEN) DC 90%
      CONCLUSION:   The product conforms to the above specifications