Description

Gemigliptin is a highly selective and potent dipeptidyl peptidase-4 (DPP-4) inhibitor. This compound is of significant commercial and research interest as the active pharmaceutical ingredient (API) in medications for the treatment of type 2 diabetes. It is primarily required by pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in the development and production of antidiabetic therapeutics.

Application

• Active Pharmaceutical Ingredient (API): Primary use in the formulation of oral antidiabetic medications for managing type 2 diabetes mellitus.
• Pharmaceutical Research & Development: Serves as a critical reference standard and building block in preclinical and clinical studies for new diabetes treatments.
• Generic Drug Manufacturing: Essential for companies producing bioequivalent versions of branded DPP-4 inhibitor drugs.
• Biochemical Research: Used as a selective tool compound to study DPP-4 enzyme kinetics, inhibition mechanisms, and related metabolic pathways in laboratory settings.
• Contract Synthesis: Supplied to CDMOs for scale-up synthesis, process optimization, and custom manufacturing projects.

Basic Information

Product Name	Gemigliptin
CAS No.	1374639-74-3
Molecular Formula	C₁₈H₂₁F₂N₅O₃
Molecular Weight	393.39 g/mol
Synonyms	LC15-0444; Zemiglo; (2R,3S,5R)-2-(2,5-Difluorophenyl)-5-(2-methylsulfonyl-5,6,7,8-tetrahydro-[1,2,4]triazolo[1,5-a]pyrazin-7-yl)tetrahydro-2H-pyran-3-amine; 7-[(3R,5S)-5-Amino-3-(2,5-difluorophenyl)tetrahydro-2H-pyran-2-yl]-2-methylsulfonyl-5,6,7,8-tetrahydro-[1,2,4]triazolo[1,5-a]pyrazine; Gemigliptin base
EINECS	Contact for details

Quality Control

Our Gemigliptin is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. We provide full traceability and support regulatory filings with detailed documentation. Certificates of Analysis (COA) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is light-sensitive and should be handled accordingly to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single unknown impurity ≤ 0.10%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Loss on Drying	≤ 0.5%

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