Description

Cyclobenzaprine n-Oxide CAS NO 6682-26-4 is a significant pharmaceutical intermediate and metabolite of the muscle relaxant cyclobenzaprine. This compound is essential for research and development in pharmacology and analytical chemistry, serving as a critical reference standard. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories. Its availability supports drug metabolism studies, impurity profiling, and quality control processes in the production of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of cyclobenzaprine and its related substances in drug products and raw materials.
• Metabolite Research: Critical for in-vitro and in-vivo studies investigating the metabolic pathways, pharmacokinetics, and pharmacodynamics of cyclobenzaprine.
• Impurity Profiling: Serves as a known impurity standard to monitor and control the quality of cyclobenzaprine API during manufacturing, ensuring compliance with ICH guidelines.
• Analytical Method Development: Employed in the development and validation of HPLC, LC-MS, and other chromatographic methods for accurate analysis.
• Bioanalytical Studies: Used in the calibration of equipment for detecting and measuring cyclobenzaprine n-Oxide in biological matrices such as plasma and urine.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) requiring detailed characterization of drug substances and their degradation products.

Basic Information

Product Name	Cyclobenzaprine n-Oxide
CAS No.	6682-26-4
Molecular Formula	C20H21NO
Molecular Weight	291.39 g/mol
Synonyms	5-(3-Dibenzocyclohepten-5-ylidene)-1-methyl-2-pyrrolidinone N-oxide; Cyclobenzaprine N-Oxide; Cyclobenzaprine Oxide; 1-Methyl-5-(3H-dibenzo[a,d]cyclohepten-5-ylidene)pyrrolidin-1-ium-1-olate; Cyclobenzaprine Impurity F (N-Oxide); Amrix Metabolite; Fexmid Metabolite
EINECS	Contact for details

Quality Control

Our Cyclobenzaprine n-Oxide is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure high purity and consistency, meeting the stringent requirements for reference standards and pharmaceutical intermediates. Certificates of Analysis (COA) are provided, detailing results from tests including identification, assay, and impurity profile by HPLC. We support compliance with relevant pharmacopeial standards and ICH Q3A/B guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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