Description

Tizanidine Hydrochloride CAS NO 64461-82-1 is a centrally acting muscle relaxant belonging to the imidazoline chemical class. It is a critical active pharmaceutical ingredient (API) valued for its efficacy in managing spasticity associated with neurological conditions. This high-purity compound is essential for pharmaceutical manufacturers developing generic and branded formulations, including tablets and capsules, for the global healthcare market.

Application

• Primary use as an Active Pharmaceutical Ingredient (API) in the manufacture of generic and branded muscle relaxant medications.
• Formulation into solid oral dosage forms such as tablets and capsules for the treatment of muscle spasticity.
• Indicated for the management of spasticity resulting from multiple sclerosis, spinal cord injuries, and other neurological disorders.
• Used in clinical research and development for exploring new therapeutic applications and delivery mechanisms.
• Serving as a reference standard in analytical laboratories for quality control and method validation.
• Potential use in compounding pharmacies for tailored patient-specific therapies.

Basic Information

Product Name	Tizanidine Hydrochloride
CAS No.	64461-82-1
Molecular Formula	C9H8ClN5S • HCl
Molecular Weight	290.16 g/mol
Synonyms	5-Chloro-N-(4,5-dihydro-1H-imidazol-2-yl)-2,1,3-benzothiadiazol-4-amine hydrochloride; Tizanidine HCl; Sirdalud; Zanaflex; DS 103-282; 4-(2-Benzothiazolylamino)-2-imidazoline hydrochloride
EINECS	Contact for details

Quality Control

Our Tizanidine Hydrochloride is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical use. A Certificate of Analysis (COA) detailing purity, identity, and impurity profiles is provided with every shipment, confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. Ensure the storage area is well-ventilated.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Microbial Limits	Conforms to EP/USP requirements

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.