Description

Cyclobenzaprine Hcl CAS NO 303-53-7 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 medications prescribed for the relief of muscle spasms associated with acute, painful musculoskeletal conditions. This compound is essential for pharmaceutical manufacturers producing generic and branded muscle relaxant formulations, serving the global healthcare and contract manufacturing sectors.

Application

• Pharmaceutical API: The primary application is as the active ingredient in oral tablet formulations for the treatment of muscle spasms.
• Generic Drug Manufacturing: Serves as a key raw material for producers of bioequivalent generic cyclobenzaprine hydrochloride medications.
• Contract Research & Development: Used in R&D laboratories for formulation studies, stability testing, and the development of new drug delivery systems.
• Analytical Reference Standard: High-purity grades are utilized as reference standards in quality control laboratories for HPLC, UV, and other analytical methods.
• Clinical Trial Material: Supplied under current Good Manufacturing Practice (cGMP) for use in clinical studies and trials.

Basic Information

Product Name	Cyclobenzaprine Hydrochloride
CAS No.	303-53-7
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; Amrix (brand name); Flexeril (brand name); Fexmid (brand name); Cyclobenzaprine Hydrochloride USP
EINECS	206-146-5

Quality Control

Our Cyclobenzaprine Hydrochloride is manufactured and tested to meet stringent pharmacopeial standards, including USP monograph requirements. Every batch undergoes comprehensive analytical testing for identity, purity, potency, and specified impurities. A Certificate of Analysis (COA) documenting results for assay, related substances, residual solvents, heavy metals, and microbiological attributes is provided with each shipment. We support regulatory filings with cGMP-compliant documentation and stability data.

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. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference standard
Assay (on dried basis)	98.0% - 102.0%
Loss on Drying	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Heavy Metals	≤ 20 ppm
Residual Solvents	Complies with ICH Q3C
Microbiological Enumeration	Complies with USP <61>

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