Description

Chlorpheniramine Impurity CAS NO 872811-44-4 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 Chlorpheniramine Maleate, a widely used antihistamine API. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in drug production.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific impurities in Chlorpheniramine Maleate Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (HPLC, UPLC, GC) for accurate impurity detection.
• Quality Control and Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with pharmacopeial standards (USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation of degradation products during forced degradation and long-term stability studies of Chlorpheniramine formulations.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over the manufacturing process.
• Research and Development: Facilitates studies on the synthesis pathway, degradation mechanisms, and metabolic pathways of Chlorpheniramine and related compounds.

Basic Information

Product Name	Chlorpheniramine Impurity
CAS No.	872811-44-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Chlorpheniramine Related Compound; Chlorpheniramine Maleate Impurity; Chlorpheniramine Degradation Product; 2-[4-Chlorophenyl(pyridin-2-yl)methoxy]-N,N-dimethylethanamine Impurity; (4-Chlorophenyl)(2-pyridinyl)methoxy-N,N-dimethylethanamine Impurity; Chlorphenamine Impurity; Chlor-Trimeton Impurity
EINECS	Contact for details

Quality Control

Our Chlorpheniramine Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your quality and regulatory documentation.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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