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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:

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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