Description

Aceclofenac-D4,13C2 is a stable isotope-labeled analog of the non-steroidal anti-inflammatory drug (NSAID) aceclofenac, specifically designed for use as an internal standard in quantitative analytical methods. This high-purity reference material is essential for ensuring accuracy and reliability in mass spectrometry-based analyses, such as LC-MS/MS, by correcting for variations in sample preparation and instrument response. It is a critical tool for pharmaceutical researchers, contract research organizations (CROs), and analytical laboratories engaged in drug metabolism and pharmacokinetics (DMPK) studies, bioequivalence testing, and therapeutic drug monitoring.

Application

• Internal Standard for Quantitative Bioanalysis: Primary use as a deuterated and carbon-13 labeled internal standard in LC-MS/MS methods for the precise quantification of aceclofenac and its metabolites in biological matrices (plasma, serum, urine).
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical research.
• Bioequivalence and Biosimilarity Testing: Supports high-accuracy comparative analysis of generic and innovator drug formulations in regulatory submissions.
• Therapeutic Drug Monitoring (TDM): Facilitates the development of robust clinical assays to monitor patient drug levels for optimal dosing and safety.
• Pharmaceutical Impurity Profiling: Used in method development to identify and quantify potential deuterated impurities or related substances in active pharmaceutical ingredient (API) batches.
• Forensic and Anti-Doping Analysis: Serves as a reference compound in confirmatory methods for detecting NSAID misuse in sports or forensic toxicology.

Basic Information

Product Name	Aceclofenac-D4,13C2
CAS No.	1795019-63-4
Molecular Formula	C14H9D413C2Cl2NO4
Molecular Weight	~ 359.19 g/mol (Calculated for labeled form)
Synonyms	2-[(2,6-Dichlorophenyl)amino]benzeneacetic acid carboxymethyl ester-D4,13C2; [[(2,6-Dichlorophenyl)amino]phenyl-13C2-D4]acetic acid carboxymethyl ester; Aceclofenac-13C2,D4; Deuterated Aceclofenac Internal Standard; Aceclofenac (phenyl-13C2,D4); Stable Isotope Labeled Aceclofenac
EINECS	Contact for details

Quality Control

Every batch of Aceclofenac-D4,13C2 is manufactured and analyzed under strict quality management systems. We guarantee high chemical and isotopic purity to meet the exacting demands of analytical reference standards. Comprehensive testing includes identification, assay (HPLC), isotopic enrichment (MS), and control of related substances and residual solvents. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results. Our quality commitment ensures compliance with the standards expected in pharmaceutical R&D and regulatory analysis.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C (refrigerated) for long-term stability. This compound is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to minimize exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to expected mass spectrum
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment	≥ 99 atom % D, ≥ 99 atom % 13C (on labeled positions)
Chemical Purity (by HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%, Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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