Tolperisone hydrochloride

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

Specification:A: In accordance with Chinese National standard WS-10001-(HD-1072)-2002Appearance:  A white crystalline powder.Melting point: 174～178℃pH: 4.5～5.5Loss on drying: ≤0.5%Residue on ignition: ≤0.1%Heavy Metal: ≤10ppmAssay: ≥99.0%B: In accordance with Japanese PharmacopeiaAppearance: A white crystalline powder.Melting point: 167～174℃Absorbance: 555～585pH: 4.5～5.5Sulfate: ≤0.005%Piperidine hydrochloride: ≤0.1%Loss on drying: ≤0.5%Residue on ignition: ≤0.1%Heavy Metal: ≤20ppmAssay: Not less than 98.5% of C₁₆H₂₃NO·HCl on the dried basis.C: Registration Specification in RussiaAppearance: White or off-white crystalline powderSolubility: 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: ≤20ppmAssay: 98.5%～101.5% of C₁₆H₂₃NO·HCl calculated on dried basis.Total aerobic microbial count: ≤100 cfu /gTotal yeast and mold count: ≤10 cfu /gStaphylococcus aureus: Should be absent in 1g.Pseudomonas aeruginosa: Should be absent in 1g.Bile-resistant Enterobacteriaceae: Should be absent in 1g.Packing size: 20Kg/drumAuthentication code: Guo Yao Zhun Zi H37023404Indications: A medicine for central muscle relaxant. It dilates blood vessels.