Description

Chlorphenamine Impurity 16 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 antihistamine drug Chlorphenamine (Chlorpheniramine). It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and impurity profiling in quality control processes.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Chlorphenamine (Chlorpheniramine) active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, and GC analytical methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to ensure products meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing definitive impurity characterization data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation of degradation products in Chlorphenamine formulations under various stress conditions.
• Research & Development: Used in academic and industrial R&D to study the metabolism, degradation pathways, and synthesis of Chlorphenamine and related compounds.

Basic Information

Item	Details
Product Name	Chlorphenamine Impurity 16
CAS No.	78180-89-9
Molecular Formula	C16H19ClN2
Molecular Weight	274.79 g/mol
Synonyms	Chlorpheniramine Impurity 16; 2-[4-Chlorophenyl(pyridin-2-yl)methyl]-1H-isoindole-1,3(2H)-dione; Chlorphenamine Related Compound 16; Chlorpheniramine Maleate Impurity 16; 4-Chloro-α-(2-pyridyl)benzenemethanol Phthalimide; Phthalimide derivative of Chlorpheniramine; N-(4-Chloro-α-pyrid-2-ylbenzyl)phthalimide
EINECS	Contact for details

Quality Control

Every batch of Chlorphenamine Impurity 16 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques (HPLC, GC-MS, NMR) to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant guidelines.

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 desiccated conditions.

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 ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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