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      Tolperisone hydrochloride

      Chemical name: 2-Methyl-1-(4-methylphenyl)-3-piperidin-1-ylpropan-1-one monohydrochloride
      Molecular formula:C16H23NO•HCl
      Molecular weight: 281.83
      CAS: 3644-61-9
      Structural formula:

      Specification:
      A: In accordance with Chinese National standard WS-10001-(HD-1072)-2002
      Appearance:  A white crystalline powder.
      Melting point: 174~178℃
      pH: 4.5~5.5
      Loss on drying: ≤0.5%
      Residue on ignition: ≤0.1%
      Heavy Metal: ≤10ppm
      Assay: ≥99.0%
      B: In accordance with Japanese Pharmacopeia
      Appearance: A white crystalline powder.
      Melting point: 167~174℃
      Absorbance: 555~585
      pH: 4.5~5.5
      Sulfate: ≤0.005%
      Piperidine hydrochloride: ≤0.1%
      Loss on drying: ≤0.5%
      Residue on ignition: ≤0.1%
      Heavy Metal: ≤20ppm
      Assay: Not less than 98.5% of C16H23NO·HCl on the dried basis.
      C: Registration Specification in Russia
      Appearance: White or off-white crystalline powder
      Solubility: Freely soluble in water, ethanol 96%, slightly soluble or very slightly soluble in acetone.
      Melting point: 167~174℃(with decomposition)
      Absorbance: 555-585(at 257nm calculated on dried basis)
      pH: 4.5~5.5(5% Water solution)
      Sulfate: ≤0.005%
      Piperidine hydrochloride: ≤0.1%(optical density of the solution not more than 0.500)
      Loss on drying: ≤0.5%
      Sulfated ash: ≤0.1%
      Heavy Metal: ≤20ppm
      Assay: 98.5%~101.5% of C16H23NO·HCl calculated on dried basis.
      Total aerobic microbial count: ≤100 cfu /g
      Total yeast and mold count: ≤10 cfu /g
      Staphylococcus aureus: Should be absent in 1g.
      Pseudomonas aeruginosa: Should be absent in 1g.
      Bile-resistant Enterobacteriaceae: Should be absent in 1g.
       
      Packing size: 20Kg/drum
      Authentication code: Guo Yao Zhun Zi H37023404
      Indications: A medicine for central muscle relaxant. It dilates blood vessels.

       
       
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