Description

Indometacin Impurity 17 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the non-steroidal anti-inflammatory drug (NSAID) Indomethacin. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions involved in method development, impurity profiling, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Indomethacin Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurities during drug manufacturing.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure analytical procedures are performing as intended for impurity detection.
• Stability Studies: Employed to track the formation of degradation products in Indomethacin under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities, as required in drug master files (DMFs).
• Research & Development: Utilized in pharmacokinetic and metabolic studies to understand the degradation pathways and safety profile of Indomethacin.

Basic Information

Product Name	Indometacin Impurity 17
CAS No.	10414-67-2
Molecular Formula	C19H16ClNO4
Molecular Weight	357.79 g/mol
Synonyms	1-(4-Chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid; Indomethacin Impurity 17; Indomethacin Related Compound 17; 5-Methoxy-2-methyl-1-(4-chlorobenzoyl)indole-3-acetic acid; 1-(p-Chlorobenzoyl)-5-methoxy-2-methylindole-3-acetic acid; 3-Acetyl-1-(4-chlorobenzoyl)-5-methoxy-2-methylindole; Indometacin EP Impurity C
EINECS	Contact for details

Quality Control

Every batch of Indometacin Impurity 17 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards (USP, EP, ICH). A comprehensive Certificate of Analysis (COA) detailing batch-specific results 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). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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 ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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