DESCRIPTION:
Tolperisone hydrochloride is white crystal powder with foreign odor, easily soluble in water and ethanol, slightly soluble in acetone, almost insoluble in benzene or aether.
Molecular formula: C16H23NO·HCL
Molecular weight: 281.83
SPECIFICATION
A:
|
Properties
|
National drug standard WS-10001-(HD-1072)-2002
|
|
Appearance
|
white or similar to white crystal powder
|
|
Assay
|
Not less than 99.0%
|
|
Melting point
|
174-178
|
|
Loss on drying
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Not more than 0.5%
|
|
Residue on ignition
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Not more than 0.1%
|
|
Acidity
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4.5-5.5
|
|
Heavy metals
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Not more than 10ppm
|
|
Clarity
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Clear
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B:
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Properties
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Accord with Japan Pharmaceopoeia 14th edition
|
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Appearance
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A white crystalline powder
|
|
Assay
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Not less than 98.5
|
|
Ph
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4.5-5.5
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|
Melting point
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167-174
|
|
Reidue on ignition
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Not more than 0.1%
|
|
Loss on drying
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Not more than 0.5%
|
|
Sulphated ash
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Not more than 0.1%
|
USE: It is a central muscle relaxant suitable for cerebral artriosclerosis,
cerebrovascular accident.
Registered number of approval: National drug standard H37023404
