Description

Tolperisone Hydrochloride is a centrally acting muscle relaxant belonging to the piperidine class of compounds. It is a critical active pharmaceutical ingredient (API) valued for its efficacy in reducing muscle tone and treating spasticity associated with neurological conditions. This high-purity compound is essential for pharmaceutical manufacturers developing formulations for the treatment of musculoskeletal disorders and related conditions.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription muscle relaxant medications.
• Tablet Formulation: Used in the production of solid oral dosage forms for systemic delivery.
• Capsule Manufacturing: Incorporated into capsule formulations for controlled or immediate release.
• Neurological Disorder Treatment: Key component in drugs targeting spasticity from multiple sclerosis, stroke, or spinal cord injuries.
• Musculoskeletal Pain Management: Used in medications for pain relief associated with muscle spasms and tension.
• Generic Drug Production: Serves as the core API for generic versions of branded tolperisone medications.
• Clinical Research: Utilized as a reference standard or raw material in pharmacological studies and clinical trials.
• Veterinary Pharmaceuticals: Potential application in veterinary medicine for animal muscle relaxation.

Basic Information

Product Name	Tolperisone Hydrochloride
CAS No.	3644-61-9
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-piperidinopropanamide Hydrochloride; Tolperison Hydrochloride; CAS 3644-61-9
EINECS	222-883-4

Quality Control

Our Tolperisone Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity pharmaceutical standards, including identity, assay, and impurity profile verification. We provide full traceability and support regulatory submissions. Certificates of Analysis (COA) documenting compliance with specifications are available upon request.

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). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after opening to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.5% - 101.0% (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%
Specific Rotation	-0.10° to +0.10° (c=1 in water)

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