Description

Cyclobenzaprine Hydrochloride is a centrally-acting skeletal muscle relaxant, chemically classified as a tricyclic amine. Its primary commercial value lies in its critical role as the active pharmaceutical ingredient (API) in formulations used to treat acute, painful musculoskeletal conditions. This compound is essential for pharmaceutical manufacturers developing generic and branded muscle relaxant medications. Rigorous quality control ensures it meets the stringent purity and safety standards required for human therapeutic use.

Application

• Pharmaceutical API: Primary use as the active ingredient in oral tablets and capsules for the relief of muscle spasms associated with acute, painful musculoskeletal conditions.
• Generic Drug Manufacturing: Sourcing for the production of bioequivalent generic versions of cyclobenzaprine hydrochloride medications.
• Branded Pharmaceutical Formulations: Utilization in the development and production of proprietary branded muscle relaxant drugs.
• Clinical Research Materials: Supply of high-purity material for preclinical studies and clinical trials investigating musculoskeletal therapies.
• Reference Standard: Use as a certified reference standard in analytical laboratories for quality control and method validation.
• Contract Manufacturing: Provision to CDMOs (Contract Development and Manufacturing Organizations) for finished dosage form production.

Basic Information

Product Name	Cyclobenzaprine Hydrochloride
CAS No.	6202-23-9
Molecular Formula	C₂₀H₂₁N•HCl
Molecular Weight	311.85 g/mol
Synonyms	Cyclobenzaprine HCl; 5-(3-Dimethylaminopropylidene)-10,11-dihydro-5H-dibenzo[a,d]cycloheptene Hydrochloride; 3-(5H-Dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine Hydrochloride; Flexeril (brand name active ingredient); Amrix (brand name active ingredient); Fexmid (brand name active ingredient); 1-Propanamine, 3-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-, hydrochloride
EINECS	228-268-7

Quality Control

Our Cyclobenzaprine Hydrochloride is manufactured under strict quality management systems. It is typically tested to meet or exceed relevant pharmacopeial standards such as USP (United States Pharmacopeia) and EP (European Pharmacopoeia) monographs. Each batch undergoes comprehensive analytical testing including identification, assay, impurity profiling, and residual solvent analysis. Certificates of Analysis (COA) documenting full compliance with specifications are provided with every shipment.

Storage

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

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (KF Titration)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Microbial Enumeration	Complies with EP/USP <61> for non-sterile substances

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