Description

Vildagliptin Impurity 20 is a high-purity chemical reference standard used in the analytical profiling and quality control of the antidiabetic drug Vildagliptin. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure drug safety, efficacy, and regulatory compliance by monitoring and controlling related substances. It is essential for method development, validation, and routine testing in the production of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Vildagliptin API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Used to track the formation and level of this specific impurity during forced degradation and long-term stability studies of Vildagliptin.
• Process Chemistry Research: Aids in the optimization of synthesis and purification processes to minimize the formation of this impurity.
• Quality Assurance/Quality Control (QA/QC): Serves as an in-house working standard for routine batch release testing of Vildagliptin.

Basic Information

Product Name	Vildagliptin Impurity 20
CAS No.	1262802-99-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vildagliptin Related Compound 20; LAF237 Impurity 20; (S)-1-[2-(3-Hydroxyadamantan-1-ylamino)acetyl]pyrrolidine-2-carbonitrile Impurity; Galvus Impurity 20; NVP-LAF-237 Impurity 20; 2-Pyrrolidinecarbonitrile, 1-[2-[[3-hydroxy-1-adamantyl]amino]acetyl]-, (2S)-, Impurity
EINECS	Contact for details

Quality Control

Our Vildagliptin Impurity 20 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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