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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