Description

Vildagliptin Impurity K CAS NO 565453-39-6 is a specified impurity of the active pharmaceutical ingredient Vildagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor used in the treatment of type 2 diabetes. This high-purity reference standard is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require reliable materials to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Vildagliptin Impurity K in drug substances and finished products.
• Analytical Method Development: Used to develop and optimize chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Critical for routine batch testing in API and finished drug product manufacturing to monitor impurity levels against ICH guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Employed as a marker to track the formation of degradation products under various stress conditions.
• Research & Development: Facilitates studies on the degradation pathways and pharmacokinetics of Vildagliptin.

Basic Information

Product Name	Vildagliptin Impurity K
CAS No.	565453-39-6
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; LAF237 Impurity K; Galvus Impurity K; NVP-LAF-237 Impurity K; 1-(((3-Hydroxy-1-adamantyl)amino)acetyl)-2(S)-cyanopyrrolidine
EINECS	Contact for details

Quality Control

Every batch of Vildagliptin Impurity K is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with each shipment to support your regulatory and quality requirements.

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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