Tizanidine HCL - USP

Tests Specification
Description Off White to light yellow crystalline powder
Solubility Soluble in methanol and water
Identification It responds to the following test A and B
A, By IR: The infrared absorption spectrum of the test substance exhibits maximum at the same wave-length as that of a similar preparation of Tizanidine Hydrochloride WRS.
B,The retention time of major peak in the chromatograph of the Assay preparation correspond to that in the chromatograph of the Standard preparation as obtained in the Assay. C, it responds to the test for Chloride
PH PH of 1%w/v solution is 4.3 to 5.3.
Loss on drying Not more than 0.5%
Residue on Ignition Not more than 0.1%
Heavy Metals Not more than 0.002%
Related compounds by HPLC
  1. Individual known impurity :
    1. Tizanidine Related compound A : NMT 0.1%
    2. Tizanidine Related compound B : NMT 0.1%
    3. Tizanidine Related compound C : NMT 0.1%
  2. Individual unknown Impurity : NMT 0.1%
  3. Total Impurity : NMT 0.3%
Assay Not less than 98.0 per cent and not more than 102.0 per cent w/w of C9H8CIN5S. HCL calculated on dried basis.