Description

Vildagliptin Carboxy Acid Metabolite Trifluoroacetate is a key chemical reference standard and synthetic intermediate, primarily associated with the active pharmaceutical ingredient Vildagliptin. This compound is essential for analytical research, method development, and quality control processes in pharmaceutical manufacturing and regulatory compliance. It is critically needed by pharmaceutical R&D laboratories, quality assurance departments, and contract research organizations (CROs) involved in the development, validation, and monitoring of antidiabetic drugs.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the quantitative and qualitative analysis of Vildagliptin and its metabolites in drug substances and finished products.
• Metabolite Studies: Critical for pharmacokinetic and pharmacodynamic research to understand the drug's metabolic pathway and profile.
• Impurity Profiling: Serves as a known impurity or degradation product marker in the stability testing and specification setting for Vildagliptin API.
• Method Development & Validation: Employed in developing and validating analytical methods, particularly HPLC, LC-MS, and related chromatographic techniques.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough characterization and control of the drug product.
• Synthetic Intermediate: Can be utilized in the research-scale synthesis of novel analogs or derivatives for further biological evaluation.

Basic Information

Product Name	Vildagliptin Carboxy Acid Metabolite Trifluoroacetate
CAS No.	565453-41-0
Molecular Formula	C19H27F3N4O6
Molecular Weight	464.44 g/mol
Synonyms	(2S)-1-[2-[(3-Hydroxy-1-adamantyl)amino]acetyl]pyrrolidine-2-carboxylic acid trifluoroacetate; LAF237 carboxylic acid metabolite TFA salt; (S)-1-((3-Hydroxy-1-adamantyl)glycyl)pyrrolidine-2-carboxylic acid trifluoroacetate; Vildagliptin M20.9 Trifluoroacetate; Vildagliptin acid metabolite TFA salt; Vildagliptin metabolite LAF237 TFA; Adamantylglycylproline carboxylic acid TFA
EINECS	Contact for details

Quality Control

Our Vildagliptin Carboxy Acid Metabolite Trifluoroacetate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and consistency, meeting the stringent requirements for pharmaceutical reference materials. Certificates of Analysis (COA) detailing results from HPLC, NMR, and MS are provided to guarantee compliance with your research and regulatory standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH limits

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