Description

Chlorpheniramine Impurity CAS NO 55486-47-0 is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of Chlorpheniramine maleate, a widely used antihistamine, by enabling the accurate identification and quantification of related substances. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical companies, contract research organizations (CROs), and regulatory testing laboratories focused on method validation and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for identifying and quantifying specific impurities in Chlorpheniramine maleate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation (HPLC/GC): Used as a critical component in developing, optimizing, and validating chromatographic methods for impurity separation and analysis.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine batch testing within pharmaceutical QC laboratories to ensure API and drug product purity meets pharmacopeial standards (USP, EP, BP).
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to monitor the formation of degradation products in Chlorpheniramine formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control and characterization.
• Research and Development (R&D): Used in synthetic chemistry R&D to study impurity formation pathways and to develop purer synthetic routes for Chlorpheniramine.

Basic Information

Product Name	Chlorpheniramine Impurity
CAS No.	55486-47-0
Molecular Formula	C16H19ClN2
Molecular Weight	274.79 g/mol
Synonyms	1-(4-Chlorophenyl)-1-(2-pyridinyl)-3-pyrrolidinopropane; Chlorpheniramine Related Compound; Chlorphenamine Impurity; 4-Chloro-α-(2-pyridyl)-N,N-dimethylbenzenepropanamine impurity; γ-(4-Chlorophenyl)-N-methyl-2-pyridinepropanamine impurity; Chlor-Trimeton Impurity; Pheniramine Impurity Derivative
EINECS	Contact for details

Quality Control

Our Chlorpheniramine Impurity is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting the batch-specific results. Our quality commitment aligns with the requirements for chemical reference standards as outlined in major pharmacopeias.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); ensure the container is kept tightly sealed in a low-humidity environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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 single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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