Description

4-Desisopropyl-4-Ethyl Nateglinide-D5 is a high-purity, stable isotope-labeled analog of a key pharmaceutical intermediate, specifically designed for use in advanced analytical and research applications. This deuterated compound is essential for ensuring the accuracy and reliability of quantitative mass spectrometry analyses, particularly in pharmacokinetic and metabolic studies. It serves as a critical reference standard for scientists and quality control professionals in the pharmaceutical development and manufacturing sectors who require precise internal standards for method validation and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified internal standard for the accurate quantification of nateglinide and related metabolites in biological matrices via LC-MS/MS and GC-MS.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Bioanalytical Method Development: Critical for developing and validating robust, sensitive, and specific analytical methods in compliance with FDA, EMA, and ICH guidelines.
• Impurity Profiling and Characterization: Used as a marker in the identification and quantification of process-related impurities and degradation products in active pharmaceutical ingredient (API) batches.
• Clinical Research: Supports therapeutic drug monitoring and bioavailability/bioequivalence studies for antidiabetic medications.
• Academic and Industrial Research: A vital tool for investigating the metabolic pathways and stability of sulfonylurea receptor ligands.

Basic Information

Product Name	4-Desisopropyl-4-Ethyl Nateglinide-D5
CAS No.	1356011-67-0
Molecular Formula	C19H20D5NO3
Molecular Weight	318.44 g/mol (for deuterated form)
Synonyms	Nateglinide D5 (4-Desisopropyl-4-Ethyl); Nateglinide-4-Ethyl-d5; N-[(trans-4-Ethyl-1-d5)cyclohexylcarbonyl]-D-phenylalanine; (2S)-2-Benzyl-3-[(trans-4-ethyl-1,2,2,3,3-d5)cyclohexanecarbonyl]propanoic Acid; Deuterated Nateglinide Impurity; Stable Isotope-Labeled Nateglinide Derivative; ATC Code A10BX03 Related Compound
EINECS	Contact for details

Quality Control

Every batch of 4-Desisopropyl-4-Ethyl Nateglinide-D5 is manufactured and analyzed under strict quality management systems. We guarantee high chemical and isotopic purity, with comprehensive testing performed using advanced techniques including NMR, HPLC, and mass spectrometry. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific data for identity, purity (HPLC assay), isotopic enrichment, and residual solvents, ensuring traceability and compliance with research and regulatory standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert atmosphere (e.g., nitrogen or argon) after opening to maintain stability and prevent degradation. For long-term storage, desiccants are recommended.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98 atom % D
Chemical Purity (NMR)	Conforms
Residual Solvents (GC)	Meets ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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