Description

Acemetacin Ep Impurity F/Carboxymethyl Acemetacin/[[[[[1-(4-Chlorobenzoyl)-5-Methoxy-2-Methyl-1H-Indol-3-Yl]Acetyl]Oxy]Acetyl]Oxy]Acetic Acid is a high-purity chemical reference standard and a key process-related impurity of the non-steroidal anti-inflammatory drug (NSAID) Acemetacin. It is critical for pharmaceutical research, development, and quality control, enabling accurate identification, quantification, and monitoring of this specific impurity during drug substance manufacturing. This compound is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable reference materials to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary application as a certified reference material for the identification and quantification of Acemetacin Impurity F in active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Used in developing and validating HPLC, UPLC, and other chromatographic methods for impurity profiling of Acemetacin.
• Quality Control & Assurance (QC/QA): Critical for routine quality control testing to monitor impurity levels and ensure API purity meets pharmacopeial specifications (e.g., EP, USP).
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this impurity under various stress conditions.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Process Chemistry Research: Used by process chemists to understand and optimize synthesis pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Acemetacin Ep Impurity F / Carboxymethyl Acemetacin
CAS No.	76812-49-2
Molecular Formula	C24H20ClNO8
Molecular Weight	485.87 g/mol
Synonyms	Carboxymethyl Acemetacin; Acemetacin Impurity F; Acemetacin Carboxymethyl Ester; [[[[[1-(4-Chlorobenzoyl)-5-Methoxy-2-Methyl-1H-Indol-3-Yl]Acetyl]Oxy]Acetyl]Oxy]Acetic Acid; 1-(4-Chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic Acid Carboxymethyl Ester; Acemetacin Related Compound F; Acemetacin EP Impurity F.
EINECS	Contact for details

Quality Control

Every batch of Acemetacin Ep Impurity F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, NMR, and MS to ensure compliance with pharmacopeial and customer-specific standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting its use in GMP-regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed 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%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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