Description

Tolperisone Hydrochloride is a centrally acting muscle relaxant, widely recognized for its efficacy in treating spasticity and muscle spasms associated with various neurological and musculoskeletal conditions. Its primary value lies in its ability to reduce muscle tone without causing significant sedation, making it a preferred choice in therapeutic regimens. This active pharmaceutical ingredient (API) is essential for manufacturers in the global pharmaceutical industry developing formulations for muscle relaxation and pain management.

Application

• Primary use as an Active Pharmaceutical Ingredient (API) in the manufacture of prescription muscle relaxant medications.
• Formulation of tablets, capsules, and other oral dosage forms for the treatment of muscle spasticity.
• Indicated for conditions such as low back pain, cervical syndrome, and other painful musculoskeletal disorders.
• Used in therapy for spasticity related to multiple sclerosis, cerebral palsy, and spinal cord injuries.
• Research and development of novel drug delivery systems and combination therapies.
• Reference standard in analytical laboratories for quality control and method validation.

Basic Information

Product Name	Tolperisone Hydrochloride
CAS No.	67499-62-1
Molecular Formula	C16H23NO • HCl
Molecular Weight	281.82 g/mol
Synonyms	2,4'-Dimethyl-3-piperidinopropiophenone Hydrochloride; Mydocalm; Mydetone; E-064; N-(2,6-Dimethylphenyl)-2-methyl-3-piperidin-1-ylpropanamide Hydrochloride; Tolperison Hydrochloride; Casfentanyl
EINECS	Contact for details

Quality Control

Our Tolperisone Hydrochloride is manufactured under strict quality management systems. It undergoes comprehensive analytical testing to ensure it meets pharmaceutical-grade specifications, including identity, purity, and impurity profile verification. Certificates of Analysis (COA) are provided with each batch, confirming compliance with relevant pharmacopoeial standards. Our commitment to cGMP principles ensures consistent quality and traceability for our global pharmaceutical partners.

Storage

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

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 (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Microbial Limits	Meets EP/USP requirements

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