Description

Clonixin Impurity 2 CAS NO 36752-40-6 is a specified impurity of the non-steroidal anti-inflammatory drug (NSAID) Clonixin. This compound is critical for pharmaceutical research and development, serving as a key reference standard in analytical method development and validation. It is essential for quality control laboratories and API manufacturers to ensure the purity, safety, and efficacy of Clonixin-based drug substances and products. Professionals in pharmaceutical analysis and regulatory affairs rely on this high-purity impurity for precise identification and quantification.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Clonixin Impurity 2 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Crucial for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurities during drug stability studies.
• Quality Control & Assurance: Used in routine QC testing to ensure Clonixin batches meet stringent pharmacopeial (e.g., USP, EP) or internal purity specifications.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (light, heat, humidity).
• Process Chemistry Research: Aids chemists in understanding and optimizing synthetic pathways to minimize the formation of this impurity.

Basic Information

Product Name	Clonixin Impurity 2
CAS No.	36752-40-6
Molecular Formula	C13H11ClN2O2
Molecular Weight	262.69 g/mol
Synonyms	2-[(2,6-Dichlorophenyl)amino]nicotinic Acid; 2-[(2,6-Dichloroanilino)]nicotinic Acid; Clonixin Impurity B; Clonixin Related Compound B; 2-(2,6-Dichloroanilino)pyridine-3-carboxylic Acid; LONIXIN Impurity 2; 3-Pyridinecarboxylic acid, 2-[(2,6-dichlorophenyl)amino]-
EINECS	Contact for details

Quality Control

Every batch of Clonixin Impurity 2 is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request, detailing purity, identity confirmation, and impurity profile as determined by advanced chromatographic techniques.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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