Description

Vildagliptin Impurity 38 is a high-purity chemical reference standard used in the analytical profiling and quality control of the antidiabetic drug Vildagliptin. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is an essential material for method development, validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Vildagliptin Impurity 38 in active pharmaceutical ingredient (API) batches.
• Analytical Method Development: Crucial for developing and validating sensitive HPLC, UPLC, or LC-MS methods for impurity profiling of Vildagliptin.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to monitor impurity levels and ensure they remain within ICH (Q3A, Q3B) and pharmacopeial (USP, EP) specified limits.
• Stability Studies: Employed to track the formation and growth of this specific impurity during forced degradation and long-term stability testing of Vildagliptin drug substance and products.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and marketing authorization applications.
• Research & Development: Facilitates process chemistry research aimed at understanding impurity formation pathways and optimizing synthesis to minimize its presence.

Basic Information

Product Name	Vildagliptin Impurity 38
CAS No.	956508-24-0
Molecular Formula	C17H25N3O2
Molecular Weight	303.40 g/mol
Synonyms	(2S)-1-[2-[(3-Hydroxy-1-adamantyl)amino]acetyl]pyrrolidine-2-carbonitrile; LAF237 Impurity 38; (S)-1-((2-((3-Hydroxyadamantan-1-yl)amino)acetyl)pyrrolidine-2-carbonitrile); Vildagliptin Related Compound 38; Galvus Impurity 38; 2-Pyrrolidinecarbonitrile, 1-[2-[[3-hydroxy-1-adamantyl]amino]acetyl]-, (2S)-; 1-[(2S)-2-Cyanopyrrolidin-1-yl]-2-[(3-hydroxy-1-adamantyl)amino]ethanone
EINECS	Contact for details

Quality Control

Our Vildagliptin Impurity 38 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from multiple orthogonal techniques, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We adhere to ICH guidelines and support compliance with cGMP standards for pharmaceutical impurities.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% 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.