Description

Vildagliptin (2R)-Isomer is the pharmacologically active enantiomer of the dipeptidyl peptidase-4 (DPP-4) inhibitor, Vildagliptin. This high-purity chiral intermediate is critical for the synthesis of advanced antidiabetic pharmaceuticals, ensuring the efficacy and safety of the final drug product. It is an essential building block for pharmaceutical manufacturers and research institutions developing or producing novel therapies for Type 2 diabetes mellitus.

Application

• Active Pharmaceutical Ingredient (API) Intermediate: Primary use as a key chiral synthon in the commercial synthesis of Vildagliptin API.
• Pharmaceutical Research & Development: Serves as a critical reference standard and starting material in metabolic disease drug discovery programs.
• Process Chemistry & Scale-Up: Used in the development and optimization of enantioselective synthetic routes for GMP manufacturing.
• Analytical Method Development: Employed as a high-purity standard for HPLC, LC-MS, and chiral assay validation in quality control laboratories.
• Regulatory Submissions: Provides the necessary certified material for impurity profiling and stability studies required by FDA, EMA, and other global health authorities.

Basic Information

Product Name	Vildagliptin (2R)-Isomer
CAS No.	1036959-27-9
Molecular Formula	C17H25N3O2
Molecular Weight	303.40 g/mol
Synonyms	(2R)-1-[2-[(3-Hydroxy-1-adamantyl)amino]acetyl]pyrrolidine-2-carbonitrile; (R)-Vildagliptin; LAF237 Isomer; (R)-NVP-LAF-237; (2R)-Vildagliptin; Galvus Impurity; DPP-4 Inhibitor Intermediate
EINECS	Contact for details

Quality Control

Our Vildagliptin (2R)-Isomer is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including chiral purity determination, to ensure it meets the stringent requirements for pharmaceutical intermediates. Certificates of Analysis (COA) with detailed chromatographic data (HPLC, Chiral HPLC) are provided and can be tailored to support regulatory filings.

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 nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.5%
Chiral Purity (Chiral HPLC)	≥99.0%
Related Substances (HPLC)	Total impurities ≤1.0%
Single Maximum Impurity	≤0.5%
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.