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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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