Description

Vildagliptin Related Compound F is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a key impurity marker and analytical standard in the quality control of Vildagliptin, an important active pharmaceutical ingredient (API) used in the treatment of type 2 diabetes. It is essential for laboratories and manufacturers requiring precise analytical methods to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Vildagliptin API and finished drug products.
• Analytical Method Development & Validation: A critical component for developing, calibrating, and validating HPLC, UPLC, and other chromatographic methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data required for drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies: Employed in forced degradation and long-term stability studies of Vildagliptin to monitor impurity formation over time and under various stress conditions.
• Process Chemistry & Optimization: Aids in monitoring and controlling impurity levels during the synthesis and purification stages of Vildagliptin manufacturing.
• Pharmacopoeial Standards: Serves as a potential impurity standard for compliance with pharmacopoeial monographs (e.g., USP, EP, JP) for Vildagliptin.

Basic Information

Product Name	Vildagliptin Related Compound F
CAS No.	1789703-36-1
Molecular Formula	C17H25N3O2
Molecular Weight	303.40 g/mol
Synonyms	(2S)-1-[2-[(3-Hydroxy-1-adamantyl)amino]acetyl]pyrrolidine-2-carbonitrile; (S)-1-(2-((3-Hydroxyadamantan-1-yl)amino)acetyl)pyrrolidine-2-carbonitrile; Vildagliptin Impurity F; Vildagliptin EP Impurity F; Vildagliptin Related Substance F; LAF237 Related Compound F; Galvus Impurity F; Adamantyl derivative of Vildagliptin
EINECS	Contact for details

Quality Control

Our Vildagliptin Related Compound F is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical analysis. Each batch undergoes comprehensive testing, including identity confirmation by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines.

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. For long-term storage, consider desiccated conditions.

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, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.