Description

Sulindac Acyl-β-D-Glucuronide is a key metabolite of the non-steroidal anti-inflammatory drug (NSAID) sulindac. This compound is of significant interest in pharmaceutical research and development, particularly for studying drug metabolism, pharmacokinetics, and the pharmacological activity of sulindac derivatives. It serves as a critical reference standard and intermediate for researchers and manufacturers in the pharmaceutical and biotechnology sectors, enabling precise analytical work and the development of advanced therapeutic agents.

Application

• Pharmaceutical Reference Standard: Primary use as a high-purity certified reference material (CRM) for quantitative and qualitative analysis in drug metabolism and pharmacokinetic (DMPK) studies.
• Metabolite Research: Essential for investigating the metabolic pathways, bioactivation, and detoxification mechanisms of the parent drug Sulindac.
• Analytical Method Development: Used to develop, validate, and calibrate sensitive analytical methods such as LC-MS/MS and HPLC for bioanalysis in preclinical and clinical studies.
• Impurity Profiling: Serves as a known impurity or degradation product standard to ensure the purity and safety of Sulindac-based pharmaceutical formulations.
• Biochemical Research: Tool for in vitro and in vivo studies aimed at understanding the role of glucuronidation in drug efficacy and toxicity.
• Regulatory Submissions: Critical component in regulatory documentation (e.g., for FDA, EMA) to characterize the drug's metabolic profile.

Basic Information

Product Name	Sulindac Acyl-β-D-Glucuronide
CAS No.	60018-36-2
Molecular Formula	C25H25NO9S
Molecular Weight	515.53 g/mol
Synonyms	Sulindac Acyl Glucuronide; (Z)-5-Fluoro-2-methyl-1-[[4-(methylsulfinyl)phenyl]methylene]-1H-indene-3-acetic acid β-D-glucopyranosiduronic acid; Sulindac β-D-Glucuronide; 1-[[(Z)-5-Fluoro-2-methyl-1-[[4-(methylsulfinyl)phenyl]methylene]-1H-inden-3-yl]acetyl]-β-D-glucopyranuronic acid; Acyl Glucuronide of Sulindac; Sulindac Metabolite
EINECS	Contact for details

Quality Control

Every batch of Sulindac Acyl-β-D-Glucuronide is manufactured and tested under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including characterization by HPLC, MS, and NMR. A detailed Certificate of Analysis (COA) is supplied with each shipment, confirming identity, purity, and strength. Our quality protocols are designed to meet the stringent requirements of pharmaceutical research and development.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability. For long-term storage, consider desiccants and inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
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.