Description

Vildagliptin Impurity 6 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Vildagliptin, a medication for type 2 diabetes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Vildagliptin API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to accurately identify and quantify this specific impurity.
• Stability Studies: Employed to monitor the formation and levels of Vildagliptin Impurity 6 in drug substances and products under various storage conditions.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization and qualification data.
• Process Chemistry Research: Used by R&D scientists to understand and optimize synthetic pathways to minimize the formation of this impurity.
• Pharmacopoeial Testing: Serves as a reference material for testing according to pharmacopoeial monographs (e.g., USP, EP) where specified.

Basic Information

Product Name	Vildagliptin Impurity 6
CAS No.	1846606-31-2
Molecular Formula	C17H23N3O2
Molecular Weight	301.39 g/mol
Synonyms	(2S)-1-[(3-Hydroxy-1-adamantyl)amino]acetyl-2-pyrrolidinecarbonitrile; (S)-1-((3-Hydroxyadamantan-1-yl)amino)acetyl-2-cyanopyrrolidine; Vildagliptin Related Compound 6; LAF237 Impurity 6; Galvus Impurity 6; Vildagliptin EP Impurity G; Vildagliptin USP Impurity 6
EINECS	Contact for details

Quality Control

Our Vildagliptin Impurity 6 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile, typically in compliance with ICH Q3A/B guidelines and relevant pharmacopoeial requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% 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.