Description

Rac Etodolac Acyl-β-D-Glucuronide is a key metabolite and reference standard of the non-steroidal anti-inflammatory drug (NSAID) etodolac. This compound is critical for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and bioanalytical method validation. It is primarily utilized by analytical laboratories, contract research organizations (CROs), and pharmaceutical companies engaged in drug discovery and regulatory compliance activities.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the quantitative and qualitative analysis of etodolac and its metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used to investigate the metabolic pathways, clearance mechanisms, and pharmacokinetic profile of etodolac.
• Bioanalytical Method Development & Validation: Essential for developing and validating sensitive HPLC, LC-MS, or LC-MS/MS methods for therapeutic drug monitoring and clinical studies.
• Impurity Profiling and Characterization: Employed to identify and quantify glucuronide conjugate impurities in active pharmaceutical ingredient (API) batches.
• Toxicology and Safety Assessment: Used in studies to understand the safety profile and potential toxicity of etodolac metabolites.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with the FDA, EMA) requiring detailed metabolite identification and quantification.

Basic Information

Product Name	Rac Etodolac Acyl-β-D-Glucuronide
CAS No.	79541-43-8
Molecular Formula	C23H29NO10
Molecular Weight	479.48 g/mol
Synonyms	1,8-Diethyl-1,3,4,9-tetrahydropyrano[3,4-b]indole-1-acetic acid β-D-glucopyranosiduronic acid; (±)-Etodolac Acyl Glucuronide; Etodolac 1-O-β-Acyl Glucuronide; rac Etodolac Acylglucuronide; Etodolac Glucuronide Metabolite; Etodolac Acyl-β-D-Glucuronide; DL-Etodolac Acyl-β-D-Glucuronide
EINECS	Contact for details

Quality Control

Our Rac Etodolac Acyl-β-D-Glucuronide is manufactured under strict quality control protocols suitable for research and analytical applications. Each batch is characterized using advanced spectroscopic and chromatographic techniques to ensure identity, purity, and stability. Certificates of Analysis (COA) detailing lot-specific results for assay, purity, and identification are provided and available upon request to support your quality assurance and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, moisture-free environment. For long-term storage under inert atmosphere, sealing under argon or nitrogen is recommended. Allow the product to equilibrate to room temperature in a desiccator before opening to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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