Description

Vildagliptin Impurity R is a designated impurity associated with the active pharmaceutical ingredient Vildagliptin, a medication used in the treatment of type 2 diabetes. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Vildagliptin-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Vildagliptin drug substance and finished products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Used to track the formation and behavior of this impurity under various stress conditions and over the shelf life of the drug.
• Research & Development: Aids in understanding the degradation pathways and synthesis by-products of Vildagliptin.

Basic Information

Product Name	Vildagliptin Impurity R
CAS No.	1803168-09-3
Molecular Formula	C17H25N3O2
Molecular Weight	303.40 g/mol
Synonyms	(2S)-1-[2-[(3-Hydroxy-1-adamantyl)amino]acetyl]pyrrolidine-2-carbonitrile; Vildagliptin Related Compound R; LAF237 Impurity R; Galvus Impurity R; (S)-1-((3-Hydroxy-1-adamantyl)glycyl)pyrrolidine-2-carbonitrile; NVP-LAF-237 Impurity R; 2-Pyrrolidinecarbonitrile, 1-[2-[(3-hydroxy-1-adamantyl)amino]acetyl]-, (2S)-
EINECS	Contact for details

Quality Control

Our Vildagliptin Impurity R is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide comprehensive Certificates of Analysis (COA) with detailed chromatograms and spectral data, ensuring traceability and compliance with ICH, USP, and EP guidelines for pharmaceutical impurities.

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 should be handled in a dry environment to prevent degradation.

Specification

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

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