Description

L-Nateglinide is a potent, fast-acting insulin secretagogue belonging to the meglitinide class of oral anti-diabetic agents. This high-purity active pharmaceutical ingredient (API) is critical for the development and manufacturing of effective type 2 diabetes treatments. It is primarily utilized by pharmaceutical companies and research institutions focused on metabolic disorders and drug formulation.

Application

• Pharmaceutical API: Core active ingredient in the manufacture of oral anti-diabetic medications for the management of type 2 diabetes mellitus.
• Drug Formulation R&D: Used in research and development for creating immediate-release tablets, capsules, and other dosage forms designed for prandial glucose control.
• Clinical Research: Serves as a reference standard and raw material in preclinical and clinical studies investigating new diabetes therapies or combination treatments.
• Generic Drug Manufacturing: Essential for producing bioequivalent generic versions of nateglinide-based drugs, ensuring cost-effective treatment options.
• Biochemical Research: Employed in laboratory studies to investigate pancreatic β-cell function, insulin secretion pathways, and the pharmacodynamics of meglitinides.

Basic Information

Product Name	L-Nateglinide
CAS No.	105816-05-5
Molecular Formula	C19H27NO3
Molecular Weight	317.42 g/mol
Synonyms	Nateglinide; (S)-N-[(trans-4-isopropylcyclohexyl)carbonyl]-D-phenylalanine; (-)-N-[(trans-4-Isopropylcyclohexyl)carbonyl]-D-phenylalanine; SDZ DJN 608; AY 4166; Starlix (Brand Name); Fastic (Brand Name); Starsis (Brand Name)
EINECS	Contact for details

Quality Control

Our L-Nateglinide is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, suitable for pharmaceutical applications. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with relevant pharmacopeial standards (e.g., USP, EP) and in-house specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Specific Rotation	-10.0° to -14.0° (c=1 in methanol)
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Loss on Drying	≤ 1.0%
Sulfated Ash	≤ 0.1%

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