Description

(R,S)-Naproxen Acyl-β-D-Glucuronide, Min. 98% is a high-purity metabolite and reference standard of the non-steroidal anti-inflammatory drug (NSAID) naproxen. This compound is essential for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and bioanalytical method validation. It is primarily used by analytical laboratories, contract research organizations (CROs), and pharmaceutical companies engaged in drug discovery and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantitative and qualitative analysis of naproxen and its metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used to investigate the metabolic pathways, clearance rates, and bioavailability of naproxen in preclinical and clinical research.
• Bioanalytical Method Development: A critical component for developing and validating sensitive HPLC, LC-MS, or LC-MS/MS assays for therapeutic drug monitoring (TDM) and toxicology studies.
• Impurity Profiling and Characterization: Employed to identify and quantify glucuronidated impurities or degradants in naproxen drug substance and finished dosage forms.
• Enzyme Activity Assays: Acts as a substrate for studying the activity of UDP-glucuronosyltransferase (UGT) enzymes involved in Phase II drug conjugation.
• Regulatory Submissions: Provides essential data to support Investigational New Drug (IND) and New Drug Application (NDA) filings with agencies like the FDA and EMA.

Basic Information

Product Name	(R,S)-Naproxen Acyl-β-D-Glucuronide, Min. 98%
CAS No.	120143-21-7
Molecular Formula	C23H24O10
Molecular Weight	460.43 g/mol
Synonyms	Naproxen Acyl Glucuronide; Naproxen 1-O-β-Acyl Glucuronide; Naproxen β-D-Glucopyranosiduronic Acid; (RS)-Naproxen Acyl-β-D-Glucuronide; (±)-Naproxen Acyl Glucuronide; Naproxen Glucuronide Metabolite; 2-(6-Methoxy-2-naphthyl)propionic acid 1-(β-D-glucopyranuronosyl) ester
EINECS	Contact for details

Quality Control

Every batch of (R,S)-Naproxen Acyl-β-D-Glucuronide is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality assurance protocol includes advanced chromatographic and spectroscopic methods. A comprehensive Certificate of Analysis (COA) detailing purity (HPLC), identity (NMR, IR), and impurity profile is provided with each shipment, supporting compliance with cGMP and ICH guidelines for reference standards.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store at -20°C or below. Allow the container to reach room temperature in a dry environment before opening to prevent condensation. The material is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	Min. 98.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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