Description

n-Desmethylchlorpheniramine is a key pharmaceutical intermediate and metabolite of the widely used antihistamine chlorpheniramine. Its primary commercial value lies in its critical role in the research, development, and quality control of active pharmaceutical ingredients (APIs) and finished drug products. This compound is essential for pharmaceutical manufacturers, analytical laboratories, and research institutions focused on pharmacokinetic studies, impurity profiling, and reference standard preparation. Ensuring a reliable supply of high-purity material is fundamental for maintaining drug safety and efficacy standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of chlorpheniramine maleate and related drug formulations.
• Metabolite Studies: Critical for in-vitro and in-vivo pharmacokinetic research to understand the metabolic pathway and bioavailability of chlorpheniramine.
• Impurity Profiling: Serves as a specified impurity marker in the quality control testing of chlorpheniramine API to ensure compliance with pharmacopeial limits (e.g., USP, EP).
• Analytical Method Development: Employed in the validation and calibration of HPLC, LC-MS, and other chromatographic methods for antihistamine analysis.
• Biomedical Research: Utilized in biochemical studies to investigate the structure-activity relationship (SAR) and mechanism of action of H1-antihistamines.
• Drug Synthesis Intermediate: Acts as a precursor in the synthetic pathway for novel antihistamine derivatives and related therapeutic compounds.

Basic Information

Product Name	n-Desmethylchlorpheniramine
CAS No.	20619-12-9
Molecular Formula	C15H17ClN2
Molecular Weight	260.76 g/mol
Synonyms	Norchlorpheniramine; Deschlorpheniramine; 2-[p-Chloro-α-(2-pyridyl)benzyl]amino]ethanol; 1-(4-Chlorophenyl)-1-(2-pyridinyl)-3-(methylamino)propane (related base structure); Chlorpheniramine Impurity C (EP); Chlorpheniramine Related Compound C (USP); Chlorpheniramine N-Desmethyl Metabolite
EINECS	Contact for details

Quality Control

Our n-Desmethylchlorpheniramine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to meet the stringent requirements for pharmaceutical reference standards and intermediates. We provide full traceability and detailed Certificates of Analysis (COA) that include data for identity, purity, and specified impurities, aligning with relevant pharmacopeial guidelines (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The material is hygroscopic (moisture-sensitive); ensure the container is kept tightly sealed in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single impurity ≤1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤0.5%

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