Description

Vildagliptin Dihydrate is a high-purity active pharmaceutical ingredient (API) used in the treatment of type 2 diabetes. This compound matters as a potent and selective dipeptidyl peptidase-4 (DPP-4) inhibitor, which enhances the body's natural ability to control blood glucose levels. Pharmaceutical manufacturers and research organizations need this API for the formulation of solid oral dosage forms, such as tablets, and for advanced clinical research into diabetes management.

Application

• Primary Active Pharmaceutical Ingredient (API) in anti-diabetic medications.
• Formulation of solid oral dosage forms, primarily film-coated tablets.
• Research and development of novel DPP-4 inhibitor-based therapies.
• Reference standard for analytical method development and quality control in pharmaceutical labs.
• Use in preclinical and clinical studies for metabolic disorder research.
• Manufacturing of generic pharmaceutical products following patent expiry.

Basic Information

Product Name	Vildagliptin Dihydrate
CAS No.	2133364-01-7
Molecular Formula	C17H27N3O2 · 2H2O
Molecular Weight	341.42 g/mol (anhydrous basis)
Synonyms	LAF237 Dihydrate; (2S)-1-[[(3-Hydroxy-1-adamantyl)amino]acetyl]-2-pyrrolidinecarbonitrile Dihydrate; NVP-LAF-237 Dihydrate; Galvus API; Vildagliptin Hydrate; DPP-4 Inhibitor Vildagliptin Dihydrate; 1-[[(3-Hydroxy-1-adamantyl)amino]acetyl]-2-cyano-(S)-pyrrolidine Dihydrate
EINECS	Contact for details

Quality Control

Our Vildagliptin Dihydrate is manufactured under strict quality management systems, targeting compliance with ICH Q7 guidelines and current Good Manufacturing Practices (cGMP). Each batch undergoes comprehensive analytical testing, including identification, assay, impurity profiling, and residual solvent analysis. A Certificate of Analysis (COA) detailing all test results against predefined specifications is provided with every shipment to ensure full traceability and regulatory support.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under conditions of low humidity to prevent degradation or clumping.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	9.0% - 11.0%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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