Description

Indomethacin Impurity 2 is a specified impurity of the non-steroidal anti-inflammatory drug (NSAID) Indomethacin, identified by CAS NO 72155-33-0. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in ensuring the purity, safety, and efficacy of Indomethacin API and its formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Indomethacin Active Pharmaceutical Ingredient (API).
• Analytical Method Development: Crucial for developing and validating HPLC, UPLC, and GC methods to monitor impurity profiles in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch testing of Indomethacin to ensure it meets pharmacopeial specifications (USP, EP, BP).
• Stability Studies: Employed to track the formation of degradation products in Indomethacin drug products under various stress conditions.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings.
• Research & Development: Supports studies on the metabolism, degradation pathways, and synthesis of Indomethacin and related compounds.

Basic Information

Product Name	Indomethacin Impurity 2
CAS No.	72155-33-0
Molecular Formula	C19H16ClNO4
Molecular Weight	357.79 g/mol
Synonyms	1-(4-Chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid; Indomethacin Impurity B; Indomethacin Related Compound B; 2-[1-(4-Chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetic acid; Indomethacin EP Impurity B; Indomethacin USP Related Compound B; 5-Methoxy-2-methyl-1-(p-chlorobenzoyl)indole-3-acetic acid
EINECS	Contact for details

Quality Control

Every batch of Indomethacin Impurity 2 is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis, to ensure it meets the high standards required for use as a reference standard. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with each shipment.

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 light-sensitive; therefore, containers must be kept tightly sealed and stored in a desiccated environment away from direct light exposure to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 0.5%
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.