Description

Vildagliptin Impurity 1 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes for the antidiabetic drug Vildagliptin. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification during analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on method development and validation for Vildagliptin and its related substances.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of Vildagliptin Impurity 1 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Used to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity profiling of Vildagliptin.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical QC laboratories to monitor impurity levels and ensure they remain within ICH (International Council for Harmonisation) guidelines.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to track the formation of this specific impurity over time and under various stress conditions.
• Research & Development: Utilized in pharmaceutical R&D to study the degradation pathways, synthesis impurities, and metabolic byproducts of Vildagliptin.

Basic Information

Product Name	Vildagliptin Impurity 1
CAS No.	1710765-32-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vildagliptin Related Compound 1; Vildagliptin EP Impurity 1; Vildagliptin USP Impurity 1; (S)-1-[2-(3-Hydroxyadamantan-1-yl)amino]acetyl]pyrrolidine-2-carbonitrile impurity; LAF237 Impurity 1; Galvus Impurity 1; NVP-LAF-237 Impurity 1
EINECS	Contact for details

Quality Control

Our Vildagliptin Impurity 1 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and related substances. Our quality protocols are designed to support compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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