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Specification of Tizanidine HydroChloride

Tests

Specification

Description

Off white to light yellow color powder

Solubility

Soluble in Methanol and water

Identification By IR
Melting Point 285oC to 290oC
Acidity pH of 5% w/v solution is 3.5 to 5.0
Heavy Metals Not more than 20PPM
Loss on drying Not more than 0.5%
Sulphate Ash Not more than 0.2%
Clarity & Color of Solution A5% w/v solution in water is clear and free from visible foreign particles and absorbance at 420nm is not more than 0.25
Related substances By HPLC [1] Individual impurity  : Not more than 0.2 %
[2] Total Impurities     : Not more than 1.0 %
Assay by HPCL  Not less than 98.0 % and not more than 102.0 % w/w of C9H8CIN5S.  HCL
 calculated on dried basis.

 

 

Ornidazole          |     Fluconazole      |      Tizanidine HCL      |      Fluxetine HCL