Description

Vildagliptin CAS NO 1147403-03-9 is a potent and selective dipeptidyl peptidase-4 (DPP-4) inhibitor, representing a critical active pharmaceutical ingredient (API) in the treatment of type 2 diabetes. Its primary value lies in its ability to enhance glycemic control by increasing the levels of incretin hormones, which stimulate insulin release in a glucose-dependent manner. This compound is essential for pharmaceutical manufacturers engaged in the development and production of antidiabetic medications, particularly for formulating oral tablets.

Application

• Pharmaceutical API: Primary use as the active ingredient in oral antidiabetic drugs for managing type 2 diabetes mellitus.
• Fixed-Dose Combination Therapies: Used in combination with other antidiabetic agents like metformin for enhanced therapeutic efficacy.
• Drug Development & Research: Serves as a key reference standard and intermediate in pharmacological research and new drug development projects.
• Formulation Development: Critical for R&D and pilot-scale production of various solid dosage forms, including film-coated tablets.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for the production of generic and branded pharmaceuticals.
• Clinical Trial Material: Used in the manufacturing of drug products for Phase I-III clinical studies.

Basic Information

Product Name	Vildagliptin
CAS No.	1147403-03-9
Molecular Formula	C17H25N3O2
Molecular Weight	303.40 g/mol
Synonyms	(2S)-1-[(3-Hydroxy-1-adamantyl)amino]acetyl-2-pyrrolidinecarbonitrile; LAF237; NVP-LAF 237; Galvus (brand name); Zomelis (brand name); DPP-4 Inhibitor LAF237; 1-[[(3-Hydroxy-1-adamantyl)amino]acetyl]-2-cyano-(S)-pyrrolidine
EINECS	Contact for details

Quality Control

Our Vildagliptin is manufactured under strict quality management systems, targeting specifications suitable for pharmaceutical applications. Quality is assured through rigorous analytical testing, including HPLC for assay and impurity profiling. While we offer various grades, our standard product aligns with common pharmacopeial expectations for APIs. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing purity, identity, and impurity limits to ensure compliance with your project requirements.

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. For long-term storage, consider using desiccants.

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%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single unknown impurity ≤ 0.10%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%

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