Description

Ent-Nateglinide Acyl-β-D-Glucuronide Benzyl Ester is a high-purity, non-natural stereoisomer metabolite reference standard of the anti-diabetic drug nateglinide. This compound is of critical importance for pharmaceutical research and development, specifically in the study of drug metabolism, pharmacokinetics, and the analytical validation of bioassays. It serves as an essential analytical standard for laboratories engaged in method development, quality control, and regulatory compliance testing within the pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the quantification and identification of nateglinide metabolites in biological matrices.
• Drug Metabolism & Pharmacokinetics (DMPK) Studies: Critical for investigating the metabolic pathways, clearance mechanisms, and stereoselective disposition of nateglinide.
• Bioanalytical Method Development & Validation: Used to develop, calibrate, and validate sensitive analytical methods such as LC-MS/MS and HPLC for clinical and pre-clinical studies.
• Quality Control & Assurance: Ensures the accuracy and reliability of analytical data in pharmaceutical quality control laboratories for batch release and stability testing.
• Impurity Profiling: Aids in the identification and characterization of process-related impurities and degradation products in nateglinide API and finished dosage forms.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for drug metabolites required in Investigational New Drug (IND) and New Drug Application (NDA) dossiers.

Basic Information

Product Name	Ent-Nateglinide Acyl-β-D-Glucuronide Benzyl Ester
CAS No.	1357003-01-0
Molecular Formula	C33H38N2O10
Molecular Weight	622.66 g/mol
Synonyms	Benzyl (2R,3S,4S,5R,6S)-3,4,5-trihydroxy-6-((((2R,3R)-4-((trans-4-isopropylcyclohexyl)carbonyl)-2-(4-methoxyphenyl)-1,2,3,4-tetrahydroisoquinolin-3-yl)oxy)carbonyl)oxy)tetrahydro-2H-pyran-2-carboxylate; (2R,3R)-N-((trans-4-Isopropylcyclohexyl)carbonyl)-N-(4-methoxyphenyl)-1,2,3,4-tetrahydro-3-isoquinolinyl β-D-Glucopyranosiduronic Acid Benzyl Ester; Ent-Nateglinide Acyl Glucuronide Benzyl Ester; Nateglinide Ent-Acyl-β-D-Glucuronide Benzyl Ester; Benzyl Ent-Nateglinide Acylglucuronide
EINECS	Contact for details

Quality Control

Our Ent-Nateglinide Acyl-β-D-Glucuronide Benzyl Ester is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data and spectroscopic evidence. Our quality commitment aligns with the standards expected for pharmaceutical reference materials, supporting GLP and GMP compliant research.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below for long-term stability. For short-term use, the material may be stored at 2-8°C. Allow the vial to equilibrate to room temperature in a desiccator before opening to prevent condensation. The compound is hygroscopic (moisture-sensitive).

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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