Description

Vildagliptin Impurity O is a specified impurity and degradation product of the active pharmaceutical ingredient Vildagliptin, an oral anti-diabetic drug. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality control laboratories in the pharmaceutical industry who require reliable materials for ensuring drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Vildagliptin Impurity O in drug substances and finished products.
• Analytical Method Development: Used in developing and optimizing chromatographic methods (HPLC, UPLC) for impurity profiling of Vildagliptin.
• Quality Control & Assurance: Critical for routine batch testing in API and formulation manufacturing to monitor impurity levels against ICH guidelines.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) as per regulatory requirements.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data.
• Research & Development: Used in studies to understand the degradation pathways and chemistry of Vildagliptin.

Basic Information

Product Name	Vildagliptin Impurity O
CAS No.	2253194-12-4
Molecular Formula	C17H23N3O2
Molecular Weight	301.39 g/mol
Synonyms	(S)-1-[2-(3-Hydroxyadamantan-1-ylamino)acetyl]pyrrolidine-2-carbonitrile; LAF237 Impurity O; Galvus Impurity O; NVP-LAF-237 Impurity O; 1-[(2S)-2-Cyanopyrrolidin-1-yl]-2-[(3S)-3-hydroxyadamantan-1-ylamino]ethanone
EINECS	Contact for details

Quality Control

Every batch of Vildagliptin Impurity O is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with each shipment.

Storage

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

Specification

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

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