Description

Vildagliptin Impurity 19 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 analytical laboratories to ensure drug safety, efficacy, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies for the production of Vildagliptin and its related pharmaceutical formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Vildagliptin active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles during drug synthesis and manufacturing.
• Quality Control & Assurance (QC/QA): Serves as a critical benchmark in routine QC testing to ensure batch-to-batch consistency and adherence to strict pharmacopeial specifications (e.g., ICH Q3A/B).
• Stability Studies: Employed to track the formation and levels of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as per ICH guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Vildagliptin to minimize the formation of this impurity.

Basic Information

Item	Details
Product Name	Vildagliptin Impurity 19
CAS No.	243145-00-8
Molecular Formula	C17H25N3O2
Molecular Weight	303.40 g/mol
Synonyms	1-[[(3-Hydroxy-1-adamantyl)amino]acetyl]-2-cyano-(S)-pyrrolidine; (2S)-1-[(3-Hydroxyadamantan-1-yl)glycyl]pyrrolidine-2-carbonitrile; Vildagliptin Related Compound 19; LAF237 Impurity 19; Galvus Impurity 19; NVP-LAF-237 Impurity; 1-(((3-Hydroxyadamantan-1-yl)amino)acetyl)pyrrolidine-2-carbonitrile
EINECS	Contact for details

Quality Control

Every batch of Vildagliptin Impurity 19 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous testing to ensure identity, purity, and consistency, meeting the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC purity assay, related substance analysis, and structural confirmation (e.g., by NMR and MS). We support compliance with ICH, USP, and EP guidelines.

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. This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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