Description

Cyclobenzaprine Impurity 3 CAS NO 24167-44-0 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Cyclobenzaprine HCl. This compound is critical for ensuring the purity, safety, and efficacy of the final pharmaceutical product by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Cyclobenzaprine HCl API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles.
• Quality Control & Batch Release: A critical component in the QC testing of raw materials and finished products to ensure compliance with pharmacopeial limits (e.g., USP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), New Drug Applications (NDAs), and Abbreviated New Drug Applications (ANDAs).
• Research & Development: Supports synthetic route optimization and impurity fate and tolerance studies during API process development.

Basic Information

Item	Details
Product Name	Cyclobenzaprine Impurity 3
CAS No.	24167-44-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cyclobenzaprine Related Compound C; Cyclobenzaprine Impurity C; 5-(3-Dimethylaminopropylidene)-10,11-dihydro-5H-dibenzo[a,d]cycloheptene; 10,11-Dihydro-5-(3-dimethylaminopropylidene)-5H-dibenzo[a,d]cycloheptene; Cyclobenzaprine Desmethyl Impurity; Cyclobenzaprine N-Desmethyl Impurity; Cyclobenzaprine USP Related Compound C
EINECS	Contact for details

Quality Control

Our Cyclobenzaprine Impurity 3 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC purity determination, identity confirmation (IR, NMR), and residual solvent analysis to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. Certificates of Analysis (COA) with detailed chromatographic data and traceability are provided and are available upon request.

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 desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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