Description

Repaglinide is a potent, fast-acting oral hypoglycemic agent belonging to the meglitinide class, used in the management of type 2 diabetes mellitus. Its primary value lies in its ability to stimulate rapid, short-duration insulin secretion from pancreatic beta cells, offering precise postprandial glucose control. This active pharmaceutical ingredient (API) is essential for manufacturers of finished dosage forms, particularly in the production of anti-diabetic medications. Repaglinide CAS NO 108157-52-4 is a critical component for pharmaceutical companies focused on metabolic disorder therapeutics.

Application

• Primary use as an Active Pharmaceutical Ingredient (API) in the formulation of oral anti-diabetic tablets.
• Manufacturing of generic and branded medications for the treatment of type 2 diabetes mellitus.
• Used in combination therapy research and development with other anti-diabetic agents like metformin.
• Critical raw material in pharmaceutical R&D for studying insulin secretion mechanisms.
• Reference standard in analytical laboratories for quality control and method validation.
• Key component in clinical trial materials for new diabetes treatment formulations.

Basic Information

Product Name	Repaglinide
CAS No.	108157-52-4
Molecular Formula	C27H36N2O4
Molecular Weight	452.59 g/mol
Synonyms	Repaglinide; (S)-(+)-2-Ethoxy-4-[2-[[3-methyl-1-[2-(1-piperidinyl)phenyl]butyl]amino]-2-oxoethyl]benzoic Acid; AG-EE 623 ZW; NovoNorm; Prandin; Eurepa; Surepost; Gluconorm
EINECS	Contact for details

Quality Control

Our Repaglinide is manufactured under strict quality management systems, ensuring it meets the stringent requirements for pharmaceutical actives. Each batch undergoes comprehensive analytical testing, including identification, assay, and impurity profiling via validated methods such as HPLC. We provide full traceability and support regulatory submissions with comprehensive documentation. Certificates of Analysis (COA) are available upon request, confirming compliance with relevant pharmacopeial standards (e.g., USP, EP).

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 light-sensitive; therefore, containers must be kept tightly sealed in a dry environment away from direct light exposure to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Water (KF Titration)	NMT 1.0%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm
Specific Optical Rotation	+7.0° to +9.0° (c=1 in methanol)

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