Description

Vildagliptin Impurity 30 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Vildagliptin. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug safety, efficacy, and regulatory compliance by monitoring and controlling its presence. It is essential for research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Vildagliptin API and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing to ensure Vildagliptin meets stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to monitor the formation and levels of this specific degradation product under various stress conditions over time.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Supports synthetic route optimization and process chemistry studies to understand and minimize impurity formation.

Basic Information

Item	Details
Product Name	Vildagliptin Impurity 30
CAS No.	918830-94-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vildagliptin Related Compound 30; Vildagliptin EP Impurity G; Vildagliptin USP Impurity; (S)-1-[2-(3-Hydroxyadamantan-1-yl)amino]acetyl]pyrrolidine-2-carbonitrile Impurity; LAF237 Impurity; Galvus Impurity; NVP-LAF-237 Impurity
EINECS	Contact for details

Quality Control

Our Vildagliptin Impurity 30 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	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.