Description

Vildagliptin Impurity Q is a high-purity reference standard used for analytical and research purposes in the pharmaceutical industry. This compound is critical for ensuring the quality, safety, and efficacy of the antidiabetic drug Vildagliptin by serving as a key marker for impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on drug development and compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Vildagliptin active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor process-related impurities.
• Quality Control & Assurance: Used in routine batch release testing to ensure Vildagliptin drug substances and products meet stringent pharmacopeial (USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Employed as a marker to track impurity formation and degradation pathways during forced degradation and long-term stability studies of Vildagliptin formulations.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Process Chemistry Research: Aids in the investigation and control of impurity formation during the synthesis and purification of Vildagliptin, helping to optimize manufacturing processes.

Basic Information

Item	Details
Product Name	Vildagliptin Impurity Q
CAS No.	1803168-08-2
Molecular Formula	C17H25N3O2
Molecular Weight	303.40 g/mol
Synonyms	(2S)-1-[2-[(3-Hydroxy-1-adamantyl)amino]acetyl]pyrrolidine-2-carbonitrile; LAF237 Impurity Q; Galvus Impurity Q; (S)-1-((3-Hydroxyadamantan-1-yl)amino)acetyl-2-cyanopyrrolidine; NVP-LAF-237 Impurity Q; 2-Cyanopyrrolidine, 1-[2-[[3-hydroxy-1-adamantyl]amino]acetyl]-, (2S)-; UNII-7Q6K5P8F2F
EINECS	Contact for details

Quality Control

Every batch of Vildagliptin Impurity Q is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the exacting standards of pharmaceutical reference material users. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including identification (IR, NMR), assay (HPLC), and related substance analysis. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed and stored in a desiccator or under inert atmosphere to prevent degradation upon exposure to moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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