Description

Vildagliptin Impurity 2 (Mixture Of Diastereomers) is a critical reference standard used in the analytical profiling and quality control of the antidiabetic active pharmaceutical ingredient (API) Vildagliptin. This compound is essential for pharmaceutical manufacturers and analytical laboratories to identify, quantify, and control this specific impurity, ensuring the final drug product meets stringent purity and safety standards. Its primary application is in the research, development, and quality assurance processes within the pharmaceutical industry, particularly for diabetes medication.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Vildagliptin Impurity 2 in Vildagliptin API and finished dosage forms.
• Method Development and Validation: Critical for developing, optimizing, and validating analytical methods, primarily High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control (QC) & Quality Assurance (QA): Used in routine batch release testing to monitor impurity levels and ensure compliance with International Council for Harmonisation (ICH) guidelines and pharmacopeial monographs (USP, EP).
• Stability Studies: Employed to track the formation of this impurity over time under various stress conditions (heat, light, humidity) to establish drug shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Process Chemistry Research: Aids in understanding and optimizing the Vildagliptin synthesis pathway to minimize the formation of this diastereomeric impurity.

Basic Information

Item	Details
Product Name	Vildagliptin Impurity 2 (Mixture Of Diastereomers)
CAS No.	1036959-23-5
Molecular Formula	C17H25N3O2
Molecular Weight	303.40 g/mol
Synonyms	Vildagliptin Diastereomer Impurity; (S)-1-[2-(3-Hydroxy-1-adamantyl)amino]acetyl]-2-cyano-(S)-pyrrolidine Diastereomer; (S)-1-[2-((3-Hydroxytricyclo[3.3.1.13,7]dec-1-yl)amino)acetyl]pyrrolidine-2-carbonitrile Diastereomer; LAF237 Impurity 2; Galvus Impurity 2; NVP-LAF-237 Impurity 2; 2-Cyano-1-({[(3R)-3-hydroxy-1-adamantyl]amino}acetyl)-(2S)-pyrrolidine Diastereomer
EINECS	Contact for details

Quality Control

Our Vildagliptin Impurity 2 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, aligning with ICH Q3A/B guidelines for impurities in new drug substances and products. Comprehensive characterization is performed using techniques including HPLC, GC, MS, and NMR. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming batch-specific results against established specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing at 2-8°C. Handle and store under an inert atmosphere if specified for the specific grade.

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% (Area Percent)
Diastereomeric Ratio	Specified per batch on COA
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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