Description

Vildagliptin I Impurity is a high-purity chemical reference standard used in the analytical characterization and quality control of the antidiabetic active pharmaceutical ingredient, Vildagliptin. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by monitoring and controlling its presence during synthesis and formulation. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance, and analytical chemistry for method development and validation.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Vildagliptin drug substance and finished products.
• Method Development & Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, in compliance with ICH guidelines.
• Quality Control & Assurance: Used in routine QC testing to monitor impurity profiles, establish specification limits, and ensure batch-to-batch consistency.
• Regulatory Submission & Compliance: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files and investigational new drug applications.
• Stability Studies: Employed to identify and quantify degradation products formed under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Process Chemistry Research: Aids in understanding the synthetic pathway of Vildagliptin, helping to optimize processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Vildagliptin I Impurity
CAS No.	1811569-16-0
Molecular Formula	C17H23N3O2
Molecular Weight	301.39 g/mol
Synonyms	Vildagliptin Impurity I; (S)-1-[2-(3-Hydroxyadamantan-1-ylamino)acetyl]pyrrolidine-2-carbonitrile; LAF237 Impurity I; Galvus Impurity I; NVP-LAF-237 Impurity I; 2-Pyrrolidinecarbonitrile, 1-[2-[(3-hydroxy-1-adamantyl)amino]acetyl]-, (2S)-; UNII-7V8A4U6785; Adamantane derivative impurity of Vildagliptin
EINECS	Contact for details

Quality Control

Our Vildagliptin I Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, impurity profile, and analytical results, supporting compliance with ICH Q3A/B and USP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white solid
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)	≤ 0.5% w/w

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