Description

Diacetic Aceclofenac is a key pharmaceutical intermediate and impurity standard used in the synthesis and quality control of the non-steroidal anti-inflammatory drug (NSAID) Aceclofenac. Its primary value lies in enabling the production of high-purity active pharmaceutical ingredients (APIs) and serving as a critical reference material for analytical method development and validation. This compound is essential for manufacturers and quality control laboratories in the global pharmaceutical industry who require reliable, high-quality raw materials to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Intermediate: A crucial building block in the multi-step synthesis of the API Aceclofenac.
• Reference Standard: Used as an impurity or degradation product standard in HPLC, LC-MS, and other chromatographic methods for quality control of Aceclofenac batches.
• Analytical Research: Employed in method development and validation studies to establish specificity, accuracy, and detection limits for Aceclofenac analysis.
• Process Chemistry: Utilized in research and development to study and optimize synthetic pathways for Aceclofenac production.
• Regulatory Compliance: Serves as a qualified standard for generating data required for regulatory filings (e.g., ANDA, DMF) with agencies like the US FDA and EMA.

Basic Information

Product Name	Diacetic Aceclofenac
CAS No.	1216495-92-9
Molecular Formula	C18H16Cl2NO6
Molecular Weight	413.23 g/mol
Synonyms	2-[(2,6-Dichlorophenyl)amino]benzeneacetic acid, 2-(acetyloxy)ethyl ester; Aceclofenac Diacetate; Aceclofenac Impurity; Aceclofenac Related Compound; [[(2,6-Dichlorophenyl)amino]phenyl]acetic acid 2-(acetyloxy)ethyl ester; Diacetyl Aceclofenac; 2-(2,6-Dichlorophenyl)aminophenylacetic acid carboxymethyl ester acetate
EINECS	Contact for details

Quality Control

Our Diacetic Aceclofenac is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR), purity assessment by HPLC, and control of specified impurities. We provide full traceability and Certificates of Analysis (COA) are available for all shipments, detailing the results against our stringent internal specifications. Our quality commitment supports compliance with cGMP and ICH Q7 guidelines for pharmaceutical intermediates.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed to minimize exposure to atmospheric moisture. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 1.0%

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