Description

Nateglinide Acyl--D-Glucuronide is a key metabolite of the anti-diabetic drug nateglinide, formed via the glucuronidation metabolic pathway. This compound is of significant importance for pharmaceutical research and development, particularly in the fields of drug metabolism and pharmacokinetics (DMPK) studies. It serves as a critical reference standard for analytical method development, bioanalytical testing, and regulatory compliance in the pharmaceutical industry. Researchers and quality control laboratories in pharmaceutical companies and contract research organizations (CROs) require this high-purity metabolite for accurate quantification and characterization of nateglinide's metabolic profile.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantification of nateglinide and its metabolites in biological matrices during clinical and non-clinical studies.
• Drug Metabolism and Pharmacokinetics (DMPK) Research: Essential for studying the metabolic pathways, clearance mechanisms, and bioavailability of the parent drug nateglinide.
• Bioanalytical Method Development and Validation: Serves as a critical component in developing and validating sensitive HPLC, LC-MS, or LC-MS/MS methods for pharmacokinetic analysis.
• Impurity Profiling and Characterization: Used to identify and quantify process-related or degradation impurities in nateglinide drug substance and finished dosage forms.
• Toxicology and Safety Assessment: Employed in studies to understand the safety profile and potential toxicity of nateglinide metabolites.
• Regulatory Submission Support: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough understanding of a drug's metabolic fate.

Basic Information

Product Name	Nateglinide Acyl--D-Glucuronide
CAS No.	183996-85-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nateglinide Glucuronide; Nateglinide Acyl Glucuronide; Nateglinide Metabolite; (2R)-2-({4-[(1R)-1-Cyclohexyl-3-[(1R,2R)-2-hydroxy-1-methylpropyl]amino]-3-oxopropyl}phenyl)acetic acid β-D-Glucopyranosiduronic acid; STARLIX Metabolite; AY 4166 Metabolite
EINECS	Contact for details

Quality Control

Our Nateglinide Acyl--D-Glucuronide is manufactured under strict quality control protocols to ensure the high purity and consistency required for research and analytical applications. Each batch is thoroughly characterized and tested using advanced analytical techniques such as HPLC, LC-MS, and NMR. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profiles. We adhere to relevant industry standards to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Water Content	≤ 5.0%
Residual Solvents	Meets ICH guidelines

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