Description

Vildagliptin Impurity 25 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Vildagliptin. This compound is critical for ensuring the safety and efficacy of antidiabetic medications by enabling the accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory affairs teams focused on method development, validation, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Vildagliptin Impurity 25 in API and finished drug product testing.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC/UPLC methods in accordance with ICH Q2(R1) guidelines.
• Quality Control & Batch Release: Used in routine QA/QC testing to monitor impurity levels and ensure Vildagliptin API meets pharmacopeial (USP, EP) and internal specification limits.
• Stability Studies: Employed in forced degradation and long-term stability studies to track impurity formation and establish shelf-life for drug products.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to support drug approval.
• Research on Degradation Pathways: Facilitates research into the synthesis, formation mechanisms, and toxicological profiling of Vildagliptin-related impurities.

Basic Information

Product Name	Vildagliptin Impurity 25
CAS No.	1563006-28-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(2S)-1-[2-[(3-Hydroxy-1-adamantyl)amino]acetyl]pyrrolidine-2-carbonitrile; LAF237 Impurity 25; Galvus Impurity 25; (S)-1-(2-((3-Hydroxyadamantan-1-yl)amino)acetyl)pyrrolidine-2-carbonitrile; Vildagliptin Related Compound 25
EINECS	Contact for details

Quality Control

Our Vildagliptin Impurity 25 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 it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) with batch-specific data 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 (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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