Description

Gemigliptin is a highly selective and potent dipeptidyl peptidase-4 (DPP-4) inhibitor, a key class of active pharmaceutical ingredients (APIs) for managing type 2 diabetes. Its primary value lies in its ability to enhance glycemic control by increasing the levels of incretin hormones, offering a targeted therapeutic approach. This compound is essential for pharmaceutical manufacturers and research institutions engaged in the development and production of innovative antidiabetic medications. Gemigliptin CAS NO 911637-19-9 represents a critical component in the formulation of advanced oral hypoglycemic drugs.

Application

• Active Pharmaceutical Ingredient (API) in oral antidiabetic medications for type 2 diabetes mellitus.
• Pharmaceutical Research & Development for studying DPP-4 inhibition mechanisms and metabolic pathways.
• Formulation Development for creating fixed-dose combination therapies with other antidiabetic agents.
• Reference Standard in analytical laboratories for quality control and method validation.
• Preclinical and Clinical Studies investigating new therapeutic regimens for diabetes management.
• Bulk Drug Substance for contract manufacturing organizations (CMOs) producing finished dosage forms.

Basic Information

Product Name	Gemigliptin
CAS No.	911637-19-9
Molecular Formula	C₁₈H₂₁F₂N₅O₂
Molecular Weight	377.39 g/mol
Synonyms	LC15-0444; Zemiglo; (2R,3S,5R)-2-(2,5-Difluorophenyl)-5-(2-methylsulfonyl-5-pyrimidinyl)-3,4,5,6-tetrahydro-2H-pyran-3-amine; 5-[(3-Amino-6-[(2,5-difluorophenyl)methyl]-2,3,4,5-tetrahydro-2H-pyran-2-yl)methyl]-2-methylsulfonylpyrimidine; DPP-4 Inhibitor LC15-0444
EINECS	Contact for details

Quality Control

Our Gemigliptin is manufactured under strict quality management systems to ensure it meets the stringent requirements for pharmaceutical actives. Each batch is tested against comprehensive specifications, including identity, purity, and impurity profiles, aligning with ICH guidelines. Certificates of Analysis (COA) are provided with every shipment, detailing results from advanced analytical techniques like HPLC and NMR. We support compliance with cGMP, FDA, and other major pharmacopoeial standards (USP/EP) upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The product is hygroscopic (moisture-sensitive) and should be handled under conditions that minimize exposure to atmospheric humidity.

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% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Heavy Metals	≤ 20 ppm

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