Description

Acemetacin Impurity 4 is a specified impurity and degradation product of the non-steroidal anti-inflammatory drug (NSAID) Acemetacin. 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 ensuring the purity, safety, and efficacy of Acemetacin active pharmaceutical ingredients (APIs) and finished drug products. This high-purity material is primarily used by analytical chemists, quality assurance professionals, and researchers in pharmaceutical manufacturing and regulatory compliance laboratories.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Acemetacin Impurity 4 in drug substances and products.
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing and validating stability-indicating methods to monitor impurities during stability studies and release testing.
• Quality Control & Assurance: Employed in routine QC testing to ensure Acemetacin API and formulations meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles and justify specification limits.
• Research on Degradation Pathways: Facilitates studies to understand the chemical degradation mechanisms of Acemetacin.

Basic Information

Item	Details
Product Name	Acemetacin Impurity 4
CAS No.	53164-08-2
Molecular Formula	C21H18ClNO6
Molecular Weight	415.82 g/mol
Synonyms	1-(4-Chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid; Acemetacin Related Compound D; Acemetacin Degradant; Acemetacin EP Impurity D; Acemetacin USP Impurity; [[1-(4-Chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetic acid]; 2-[1-(4-Chlorobenzoyl)-5-methoxy-2-methylindol-3-yl]acetic acid
EINECS	Contact for details

Quality Control

Every batch of Acemetacin Impurity 4 is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC purity assay, related substance analysis, and structural confirmation (IR, MS, NMR) to ensure identity, strength, and purity. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific results. Our quality standards are designed to meet the requirements for use as a pharmaceutical reference standard in regulated environments.

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); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. 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 standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
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.