Tizanidine HCl BP/USP

Tizanidine is a drug that is used as a muscle relaxant. It is a centrally acting α2 adrenergic agonist. It is used to treat the spasms, cramping, and tightness of muscles caused by medical problems such as multiple sclerosis, ALS, spastic diplegia, back pain, or certain other injuries to the spine or central nervous system. It is also prescribed off-label for migraine headaches, as a sleep aid, and as an anticonvulsant. It is also prescribed for some symptoms of fibromyalgia. Specification - 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 NMT 0.5% Residue on Ignition NMT 0.1% Heavy Metals NMT 0.002% Related compounds by HPLC 1. Individual known impurity : 2. Tizanidine Related compound A : NMT 0.1% 3. Tizanidine Related compound B : NMT 0.1% 4. Tizanidine Related compound C : NMT 0.1% 5. Individual unknown Impurity : NMT 0.1% 6. Total Impurity : NMT 0.3% Assay NLT 98.0 per cent and NMT 102.0 per cent w/w of C9H8CIN5S. HCL calculated on dried basis. Packaging details: 25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. About the Company GST Registration Date: 2017 Legal Status of Firm: Partnership Number of Employees: Upto 10 People Annual Turnover: 1.5 - 5 Cr