Description

Vildagliptin Amino Adamantane Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of the antidiabetic drug Vildagliptin. This impurity, with CAS NO 875311-29-8, is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification, quantification, and control of process-related impurities. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, purification, and batch release of Vildagliptin and its formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of the Amino Adamantane-related impurity in Vildagliptin active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate high-performance liquid chromatography (HPLC), UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine quality control (QC) testing to ensure impurity levels are within International Council for Harmonisation (ICH) guidelines and drug substance specifications.
• Regulatory Compliance & Filings: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for Drug Master Files (DMFs) and New Drug Applications (NDAs).
• Process Chemistry Research: Aids in understanding and optimizing the Vildagliptin synthesis pathway to minimize the formation of this specific impurity.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to monitor impurity formation over time under various storage conditions.

Basic Information

Product Name	Vildagliptin Amino Adamantane Impurity
CAS No.	875311-29-8
Molecular Formula	C17H25N3O2
Molecular Weight	303.40 g/mol
Synonyms	(1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxy-1-adamantyl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile; Adamantane Impurity of Vildagliptin; Vildagliptin Adamantylamine Impurity; Vildagliptin Impurity A (Adamantane); Vildagliptin Related Compound A; LAF237 Impurity; Galvus Impurity
EINECS	Contact for details

Quality Control

Our Vildagliptin Amino Adamantane Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure high purity and accurate identification, meeting the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided, detailing results for identity, purity (by HPLC), and related substances. Our quality commitment aligns with cGMP principles to support your regulatory and compliance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
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%
Residue on Ignition	≤ 0.1%

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