Description

Nateglinide is a fast-acting, short-duration insulin secretagogue used for the treatment of type 2 diabetes mellitus. This pharmaceutical active ingredient is valued for its ability to provide rapid postprandial glucose control with a reduced risk of hypoglycemia. It is primarily required by pharmaceutical manufacturers for the formulation of oral anti-diabetic medications and is also utilized in research and development for metabolic studies.

Application

• Pharmaceutical Manufacturing: Primary active ingredient in oral anti-diabetic tablets for the management of type 2 diabetes.
• Research & Development: Used in biochemical and pharmacological studies to investigate insulin secretion mechanisms and glucose metabolism.
• Reference Standard: Serves as a certified reference material (CRM) for quality control and analytical method development in laboratories.
• Drug Formulation Development: Employed in pre-formulation and formulation studies for developing new dosage forms, including combination therapies.

Basic Information

Product Name	Nateglinide
CAS No.	105816-04-4
Molecular Formula	C19H27NO3
Molecular Weight	317.42 g/mol
Synonyms	Nateglinide; (2R)-2-({[trans-4-(1-Methylethyl)cyclohexyl]carbonyl}amino)-3-phenylpropanoic Acid; AY-4166; SDZ DJN 608; Starlix; Fastic; Starsis; N-(trans-4-Isopropylcyclohexanecarbonyl)-D-phenylalanine
EINECS	Contact for details

Quality Control

Our Nateglinide is manufactured and tested to meet stringent pharmaceutical-grade standards. Quality is assured through comprehensive analytical testing, including HPLC for purity and identity confirmation. A Certificate of Analysis (COA) is provided with each batch, detailing compliance with relevant specifications. Our quality management system adheres to cGMP principles to ensure consistency and reliability for our global B2B partners.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any individual impurity ≤ 0.5%
Heavy Metals	≤ 20 ppm

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