Description

Indomethacin Impurity CAS NO 5354-81-4 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 active pharmaceutical ingredient (API) indomethacin. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, stability studies, and impurity profiling. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in drug production.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity in Indomethacin API and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to ensure accurate detection and quantification limits.
• Stability Studies and Forced Degradation: Employed in stability-indicating assays to understand the degradation pathways of Indomethacin and establish shelf-life specifications.
• Quality Control and Batch Release Testing: Essential for routine QC testing in pharmaceutical manufacturing to ensure batches meet pharmacopeial (USP, EP) impurity limits.
• Regulatory Submissions and Compliance: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and ICH guidelines.
• Research and Development: Used in academic and industrial R&D to study the chemical behavior, synthesis pathways, and toxicological profile of Indomethacin-related substances.

Basic Information

Product Name	Indomethacin Impurity
CAS No.	5354-81-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-(4-Chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid; 4-Chlorodesmethylindomethacin; 4-Chlorodesmethoxyindomethacin; Indomethacin Impurity C (EP); Indomethacin Related Compound C (USP); 4-Chloroindomethacin; 1-(p-Chlorobenzoyl)-5-methoxy-2-methylindole-3-acetic acid
EINECS	Contact for details

Quality Control

Our Indomethacin Impurity is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, identity, and other critical parameters. Our quality commitment aligns with the needs of cGMP-compliant environments and supports compliance with ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment. For long-term storage, consider storing under an inert atmosphere to ensure optimal stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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