Description

Acemetacin Ep Impurity D/6-T-Butyl Acemetacin/[[[1-(4-Chlorobenzoyl)-6-(1,1-Dimethylethyl)-5-Methoxy-2-Methyl-1H-Indol-3-Yl]Acetyl]Oxy]Acetic Acid is a high-purity chemical reference standard and impurity used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the non-steroidal anti-inflammatory drug (NSAID) Acemetacin by serving as a key marker for analytical method development and validation. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for quality control, stability studies, and compliance with stringent pharmacopeial standards like EP and USP.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Acemetacin EP Impurity D in active pharmaceutical ingredient (API) batches.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and other chromatographic methods for impurity profiling of Acemetacin.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with ICH guidelines.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Critical for preparing impurity profiles and supporting documentation for drug master files (DMFs) and regulatory filings with agencies like the FDA and EMA.
• Research & Development: Serves as a tool in metabolic and pharmacokinetic studies to understand the drug's impurity pathways.

Basic Information

Product Name	Acemetacin Ep Impurity D / 6-T-Butyl Acemetacin
CAS No.	76812-64-1
Molecular Formula	C26H28ClNO6
Molecular Weight	485.96 g/mol
Synonyms	6-tert-Butyl Acemetacin; [[[1-(4-Chlorobenzoyl)-6-(1,1-Dimethylethyl)-5-Methoxy-2-Methyl-1H-Indol-3-Yl]Acetyl]Oxy]Acetic Acid; Acemetacin Impurity D (EP); Acemetacin Related Compound D; 1-(4-Chlorobenzoyl)-5-methoxy-2-methyl-6-(tert-butyl)-1H-indole-3-acetic Acid Carboxymethyl Ester; 6-(tert-Butyl)acemetacin; Acemetacin tert-Butyl Impurity.
EINECS	Contact for details

Quality Control

Every batch of Acemetacin EP Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing to ensure compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) are provided, detailing results from advanced analytical techniques such as HPLC, NMR, and MS. We support compliance with ICH Q3A/B, EP, and USP guidelines for impurities in new drug substances.

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 compound is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed and desiccated to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

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)	Total impurities ≤ 2.0% Any individual unknown 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.