Description

Vildagliptin Impurity 31 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the antidiabetic drug Vildagliptin. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) by serving as a benchmark for analytical methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method validation, stability studies, and impurity profiling to meet stringent pharmacopeial standards such as ICH Q3A and Q3B.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Vildagliptin Impurity 31 in drug substance and drug product analysis.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity detection and separation.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure the final API meets predefined specification limits.
• Stability Studies: Acts as a marker to track impurity formation and degradation pathways of Vildagliptin under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Essential for preparing impurity profiles and supporting documentation required for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Research & Development: Utilized in synthetic chemistry research to understand the formation mechanism and to develop purification processes to minimize this impurity.

Basic Information

Product Name	Vildagliptin Impurity 31
CAS No.	119694-48-3
Molecular Formula	C17H23N3O2
Molecular Weight	301.39 g/mol
Synonyms	(S)-1-[2-(3-Hydroxyadamantan-1-yl)amino]acetyl]pyrrolidine-2-carbonitrile; LAF237 Impurity 31; Galvus Impurity 31; (2S)-1-({2-[(3-Hydroxytricyclo[3.3.1.13,7]dec-1-yl)amino]-2-oxoethyl})pyrrolidine-2-carbonitrile; Vildagliptin Related Compound 31; Vildagliptin EP Impurity I; Vildagliptin USP Impurity; NVP-LAF-237 Impurity 31
EINECS	Contact for details

Quality Control

Our Vildagliptin Impurity 31 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with high-grade reference standard specifications. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with every shipment. Our quality commitment aligns with the standards expected for pharmaceutical impurities as outlined in ICH guidelines.

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 under inert atmosphere at -20°C to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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