Description

Nateglinide CAS NO 491828-09-2 is a potent, fast-acting insulin secretagogue belonging to the meglitinide class of anti-diabetic agents. It is a critical active pharmaceutical ingredient (API) used in the management of type 2 diabetes mellitus. This compound is primarily required by pharmaceutical manufacturers for the formulation of oral anti-diabetic medications. Its mechanism of action involves stimulating rapid, short-lived insulin secretion from pancreatic beta cells, making it particularly effective for controlling postprandial blood glucose spikes.

Application

• Pharmaceutical API: Primary use as the active ingredient in oral anti-diabetic tablets for type 2 diabetes treatment.
• Clinical Research: Utilized in preclinical and clinical studies for investigating new diabetes therapies and combination treatments.
• Drug Formulation Development: Serves as a reference standard and key component in the R&D of novel dosage forms and controlled-release systems.
• Generic Drug Manufacturing: Essential for the production of bioequivalent generic versions of branded nateglinide medications.
• Metabolic Disorder Research: Used in laboratory studies to understand insulin secretion pathways and pancreatic β-cell function.

Basic Information

Product Name	Nateglinide
CAS No.	491828-09-2
Molecular Formula	C19H27NO3
Molecular Weight	317.42 g/mol
Synonyms	Nateglinide; (2R,3R)-N-(trans-4-Isopropylcyclohexylcarbonyl)-D-phenylalanine; AY 4166; SDZ DJN 608; Starlix; Fastic; Starsis; DJN 608; N-(trans-4-Isopropylcyclohexylcarbonyl)-D-phenylalanine
EINECS	Contact for details

Quality Control

Our Nateglinide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. We provide full traceability and Certificates of Analysis (COA) that detail purity, identity, and impurity profiles. Our quality commitment aligns with ICH guidelines and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after opening to prevent degradation from atmospheric moisture. Store away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Optical Rotation	Specific range provided on COA

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