Description

Vildagliptin Related Compound H is a high-purity chemical reference standard and impurity used in the development and quality control of the antidiabetic drug Vildagliptin. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical products by enabling precise identification and quantification of process-related impurities. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in API synthesis, method validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the identification and quantification of Vildagliptin impurities in drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): A critical tool for in-process testing and release testing of Vildagliptin Active Pharmaceutical Ingredient (API) to meet ICH guidelines.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Process Chemistry Research: Used by R&D chemists to understand and optimize synthesis pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Vildagliptin Related Compound H
CAS No.	2253194-13-5
Molecular Formula	C17H25N3O2
Molecular Weight	303.40 g/mol
Synonyms	(S)-1-[2-(3-Hydroxyadamantan-1-ylamino)acetyl]pyrrolidine-2-carbonitrile; Vildagliptin Impurity H; LAF237 Related Compound H; Galvus Impurity H; (2S)-1-({2-[(3-Hydroxy-1-adamantyl)amino]acetyl})pyrrolidine-2-carbonitrile; NVP-LAF-237 Impurity H; Adamantane derivative impurity of Vildagliptin
EINECS	Contact for details

Quality Control

Our Vildagliptin Related Compound H is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical impurity analysis. Each batch is characterized using advanced techniques including HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) detailing purity, impurity profile, and analytical methods is provided with every shipment to support your regulatory and quality requirements.

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 product 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 (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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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