Description

Bisegliptin CAS NO 862501-61-9 is a high-purity pharmaceutical intermediate and active pharmaceutical ingredient (API) belonging to the dipeptidyl peptidase-4 (DPP-4) inhibitor class. It serves as a critical building block in the synthesis of advanced antidiabetic medications, offering researchers and manufacturers a reliable component for drug development and production. This compound is essential for pharmaceutical companies, R&D laboratories, and fine chemical suppliers focused on metabolic disorder therapeutics.

Application

• Pharmaceutical API Synthesis: Primary use as an active ingredient in the manufacture of novel antidiabetic drugs.
• DPP-4 Inhibitor Research: A key reference standard and intermediate in the research and development of new glucose-lowering agents.
• Metabolic Disorder Studies: Used in preclinical and clinical studies targeting type 2 diabetes mellitus.
• Fine Chemical Intermediate: Serves as a sophisticated building block for further chemical derivatization and process optimization.
• Analytical Reference Standard: Employed in quality control laboratories for HPLC, LC-MS, and NMR method development and validation.
• Regulatory Submission Batches: Sourced for the production of material used in stability studies and regulatory filing dossiers (e.g., for FDA, EMA).

Basic Information

Product Name	Bisegliptin
CAS No.	862501-61-9
Molecular Formula	C₁₉H₂₀N₈O₂
Molecular Weight	392.42 g/mol
Synonyms	Bisegliptin; 2-[[6-[(3R)-3-Amino-1-piperidinyl]-3,4-dihydro-3-methyl-2,4-dioxo-1(2H)-pyrimidinyl]methyl]-4-fluorobenzonitrile; (R)-2-((6-(3-Aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)-4-fluorobenzonitrile; Bisegliptin (API); DPP-4 Inhibitor Bisegliptin
EINECS	Contact for details

Quality Control

Our Bisegliptin is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure it meets high-purity standards suitable for pharmaceutical R&D and API synthesis. We provide comprehensive Certificates of Analysis (COA) detailing purity, identity, and impurity profiles, supporting compliance with ICH guidelines and customer-specific requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed under inert atmosphere or with appropriate desiccants to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0%
Any single unknown impurity	≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤1.0%
Heavy Metals	≤20 ppm

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