Description

Vildagliptin Impurity E CAS NO 1789703-37-2 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of specific impurities during the development and manufacturing of the antidiabetic drug Vildagliptin. It is an essential material for analytical laboratories, research institutions, and pharmaceutical companies focused on method validation, regulatory compliance, and ensuring drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for calibrating analytical instruments and validating testing methods in QC/QA laboratories.
• Impurity Profiling & Characterization: Used to study the degradation pathways and stability of Vildagliptin drug substance and finished products.
• Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to separate and quantify Vildagliptin-related impurities.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing definitive impurity identification data.
• Research & Development: Utilized in academic and industrial R&D for studying the chemical and metabolic behavior of Vildagliptin.
• Quality Control Testing: Serves as a system suitability standard in routine batch release testing of Vildagliptin Active Pharmaceutical Ingredient (API).

Basic Information

Product Name	Vildagliptin Impurity E
CAS No.	1789703-37-2
Molecular Formula	C17H23N3O2
Molecular Weight	301.39 g/mol
Synonyms	(S)-1-[2-(3-Hydroxy-1-adamantyl)amino]acetyl]-2-cyano-pyrrolidine; Vildagliptin Related Compound E; LAF237 Impurity E; (2S)-1-({2-[(3S)-3-Hydroxyadamantan-1-yl]amino}acetyl)pyrrolidine-2-carbonitrile; Galvus Impurity E; NVP-LAF-237 Impurity E; Adamantyl Derivative Impurity of Vildagliptin
EINECS	Contact for details

Quality Control

Our Vildagliptin Impurity E is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every 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 light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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