Description

Nateglinide-D5 is a deuterated internal standard of the anti-diabetic drug Nateglinide, essential for ensuring analytical accuracy in quantitative bioanalysis. This high-purity, isotopically labeled compound is critical for pharmaceutical research and development, particularly in pharmacokinetic and metabolic studies. It is primarily used by analytical laboratories, CROs, and pharmaceutical manufacturers engaged in method development and quality control for diabetes therapeutics.

Application

• Internal Standard for LC-MS/MS: Used as a stable, isotopically labeled internal standard for the precise quantification of Nateglinide in biological matrices (e.g., plasma, serum) via liquid chromatography-tandem mass spectrometry (LC-MS/MS).
• Pharmacokinetic (PK) Studies: Enables accurate measurement of drug absorption, distribution, metabolism, and excretion (ADME) profiles in clinical and pre-clinical research.
• Bioanalytical Method Development & Validation: Serves as a critical reference material for developing, optimizing, and validating robust analytical methods compliant with FDA, EMA, and ICH guidelines.
• Drug Metabolism Research: Facilitates the study of Nateglinide's metabolic pathways and the identification of its metabolites.
• Quality Control in Pharmaceutical Manufacturing: Supports impurity profiling and assay validation for Nateglinide active pharmaceutical ingredient (API) and finished dosage forms.
• Forensic and Doping Analysis: Applied in specialized testing where accurate quantification of Nateglinide is required.

Basic Information

Product Name	Nateglinide-D5
CAS No.	1227666-13-8
Molecular Formula	C19H22D5NO3
Molecular Weight	329.44 g/mol (approximate)
Synonyms	Nateglinide-d5; (2R)-2-[(4-Isopropylcyclohexyl)carbonyl]amino-3-phenyl-d5-propanoic Acid; N-[(trans-4-Isopropylcyclohexyl)carbonyl]-D-phenylalanine-d5; Starlix-d5; Fastic-d5; Starsis-d5; A-4166-d5; Deuterated Nateglinide
EINECS	Contact for details

Quality Control

Our Nateglinide-D5 is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing parameters such as isotopic enrichment (D-content), chemical purity (by HPLC), and identity confirmation (by NMR and MS). We adhere to relevant industry standards for reference materials. COAs are available upon request.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98.0 atom % D
Chemical Purity (by HPLC)	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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