Description

Vildagliptin Related Compound A 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) for type 2 diabetes treatment. It is essential for analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical industry to ensure product purity, safety, 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: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods in QC laboratories.
• Stability Studies: Employed to monitor degradation pathways and establish impurity limits during forced degradation and long-term stability testing of Vildagliptin formulations.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Pharmacopoeial Testing: Supports testing in compliance with monographs from pharmacopoeias such as USP, EP, or JP that specify impurity limits.
• In-House Quality Control: Used by API manufacturers and finished dosage form producers for routine batch release testing and specification adherence.

Basic Information

Product Name	Vildagliptin Related Compound A
CAS No.	741657-02-3
Molecular Formula	C17H25N3O2
Molecular Weight	303.40 g/mol
Synonyms	(2S)-1-[2-[(3-Hydroxy-1-adamantyl)amino]acetyl]pyrrolidine-2-carbonitrile; LAF237 Related Compound A; Galvus Impurity A; (S)-1-((3-Hydroxyadamantan-1-yl)amino)acetyl-2-cyanopyrrolidine; NVP-LAF-237 Related Substance A; Adamantyl derivative of Vildagliptin; DPP-4 Inhibitor Related Compound A
EINECS	Contact for details

Quality Control

Our Vildagliptin Related Compound A is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity determination, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccant in the container.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
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%
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.