Description

Vildagliptin Dione Impurity is a high-purity chemical reference standard used in the analytical profiling of the antidiabetic drug Vildagliptin. This compound is critical for pharmaceutical research and development, enabling the identification, quantification, and control of process-related impurities to ensure drug safety and efficacy. It is an essential material for quality control laboratories, regulatory affairs, and analytical scientists working in pharmaceutical manufacturing and API development.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for method development and validation in HPLC and LC-MS analysis.
• Drug Substance Impurity Profiling: Critical for identifying and quantifying specific degradants or process-related impurities in Vildagliptin active pharmaceutical ingredient (API) batches.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized impurity data for drug master files.
• Stability Studies: Used as a marker to monitor the formation of specific degradation products under various stress conditions (e.g., heat, light, humidity).
• Quality Control & Release Testing: Enables in-house QC laboratories to perform accurate assay and impurity testing against a qualified reference standard.
• Research & Development: Facilitates synthetic route optimization and process chemistry studies by tracking the formation and purge of this specific impurity.

Basic Information

Product Name	Vildagliptin Dione Impurity
CAS No.	1844894-70-7
Molecular Formula	C17H23N3O2
Molecular Weight	301.39 g/mol
Synonyms	(S)-1-[2-(3-Hydroxy-1-adamantyl)amino]acetyl]-2-cyano-pyrrolidine Dione Impurity; LAF237 Dione Impurity; Galvus Dione Impurity; Vildagliptin Adamantyl Dione Impurity; Vildagliptin Related Compound Dione; 2-[[(1S)-2-Cyano-1-(2,4-dioxopyrrolidin-3-yl)ethyl]amino]acetic Acid Adamantyl Derivative; 1844894-70-7
EINECS	Contact for details

Quality Control

Every batch of Vildagliptin Dione Impurity CAS 1844894-70-7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (HPLC, LC-MS, NMR) to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

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)	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.