Description

Vildagliptin Impurity A-F is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the antidiabetic drug Vildagliptin by accurately identifying and quantifying related substances. It is an essential material for analytical chemists and quality assurance professionals working in pharmaceutical R&D, quality control laboratories, and regulatory affairs.

Application

• Pharmaceutical Reference Standard: Primary use 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: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Used in routine QC testing to ensure Vildagliptin batches meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Employed to track the formation of degradation products in Vildagliptin under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A guidelines.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to demonstrate comprehensive impurity control.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Vildagliptin to minimize the formation of this specific impurity.

Basic Information

Product Name	Vildagliptin Impurity A-F
CAS No.	1846606-32-3
Molecular Formula	C17H25N3O2
Molecular Weight	303.40 g/mol
Synonyms	(2S)-1-[2-[(3-Hydroxy-1-adamantyl)amino]acetyl]pyrrolidine-2-carbonitrile; LAF237 Impurity A-F; Galvus Impurity A-F; NVP-LAF-237 Impurity A-F; (S)-1-(2-((3-Hydroxyadamantan-1-yl)amino)acetyl)pyrrolidine-2-carbonitrile; Vildagliptin Related Compound A-F
EINECS	Contact for details

Quality Control

Every batch of Vildagliptin Impurity A-F is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC/UPLC) and spectroscopic (NMR, MS) techniques to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting 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. Due to its hygroscopic nature, the container should be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain 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)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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