Description

Cyclobenzaprine Impurity CAS NO 1971-54-6 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Cyclobenzaprine HCl. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is fundamental for maintaining the highest standards in pharmaceutical quality control.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity in Cyclobenzaprine HCl API and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or GC methods to ensure accurate impurity detection.
• Stability Studies and Forced Degradation: Employed in stability-indicating assays to understand degradation pathways and establish shelf-life for Cyclobenzaprine-containing products.
• Quality Control and Batch Release Testing: Essential for routine QC testing in pharmaceutical manufacturing to ensure batches meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Used in R&D to study the chemical and toxicological properties of this impurity, supporting risk assessment and process optimization.

Basic Information

Product Name	Cyclobenzaprine Impurity
CAS No.	1971-54-6
Molecular Formula	C20H21N
Molecular Weight	275.39 g/mol
Synonyms	10,11-Dihydro-5H-dibenzo[a,d]cyclohepten-5-one, 10,11-Dihydro-5H-dibenzo[a,d]cyclohepten-5-one imine, 5H-Dibenzo[a,d]cyclohepten-5-one, 10,11-dihydro-, imine, Cyclobenzaprine Related Compound, Cyclobenzaprine Ketimine Impurity
EINECS	Contact for details

Quality Control

Every batch of Cyclobenzaprine Impurity (CAS 1971-54-6) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting traceability and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, well-ventilated area. Keep the container sealed to protect the material from moisture and atmospheric contaminants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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