Description

Dexchlorpheniramine Impurity CAS NO 73775-50-5 is a high-purity reference standard critical for analytical and regulatory purposes in pharmaceutical development. This compound is essential for ensuring the quality, safety, and efficacy of the antihistamine drug Dexchlorpheniramine Maleate by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Dexchlorpheniramine Maleate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating chromatographic methods (HPLC, UPLC, GC) to ensure specificity, accuracy, and precision in impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A(R2), Q3B(R2), and pharmacopeial specifications (USP, EP, JP).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (heat, light, humidity) as part of ICH stability-indicating methods.
• 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 & Development: Supports synthetic route optimization and process chemistry research to understand and minimize impurity formation during API synthesis.

Basic Information

Product Name	Dexchlorpheniramine Impurity
CAS No.	73775-50-5
Molecular Formula	C16H19ClN2
Molecular Weight	274.79 g/mol
Synonyms	Dexchlorpheniramine Related Compound; (+)-Chlorpheniramine Impurity; (S)-Chlorpheniramine Impurity; Dexchlorpheniramine Maleate Impurity; 2-[p-Chloro-α-[(2-dimethylaminoethyl)benzyl]pyridine Impurity; (S)-1-(4-Chlorophenyl)-1-(2-pyridyl)-3-dimethylaminopropane; Dexchlorpheniramine Free Base Impurity
EINECS	Contact for details

Quality Control

Every batch of Dexchlorpheniramine Impurity CAS 73775-50-5 is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity, purity, and assay testing using validated analytical methods (including HPLC, GC, NMR, and MS) to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your regulatory and quality requirements.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white solid
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 impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w
Assay (HPLC)	97.0% - 103.0% (on anhydrous basis)

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