Description

Trelagliptin CAS NO 1243378-31-5 is a potent, long-acting dipeptidyl peptidase-4 (DPP-4) inhibitor used as an active pharmaceutical ingredient (API). It is a critical component in the formulation of antidiabetic medications, offering a once-weekly dosing regimen for improved patient compliance. This high-purity compound is essential for pharmaceutical manufacturers and research institutions developing advanced treatments for type 2 diabetes mellitus.

Application

• Pharmaceutical API: Primary use as the active ingredient in once-weekly oral antidiabetic tablets.
• Drug Formulation R&D: Used in the development and optimization of sustained-release and fixed-dose combination drug products.
• Reference Standard: Serves as a high-purity analytical standard for quality control and method validation in pharmaceutical laboratories.
• Clinical Research: Employed in preclinical and clinical studies investigating new diabetes therapies and combination treatments.
• Process Chemistry: Used as a key intermediate or final product in the scale-up and optimization of synthetic routes for DPP-4 inhibitors.

Basic Information

Product Name	Trelagliptin
CAS No.	1243378-31-5
Molecular Formula	C₁₈H₂₀FN₅O₂
Molecular Weight	357.38 g/mol
Synonyms	Trelagliptin; Trelagliptin Succinate; SYR-472; Zafatek; (2R,3S,5R)-2-(2,5-Difluorophenyl)-5-[2-(methylsulfonyl)-2,6-dihydro-4H-pyrrolo[3,4-c]pyrazol-5-yl]tetrahydro-2H-pyran-3-amine; DPP-4 Inhibitor SYR-472; 5-{[(3R)-3-Amino-2-(2,5-difluorophenyl)-3,6-dihydro-2H-pyran-4-yl]methyl}-2-(methylsulfonyl)-2,4,6,7-tetrahydropyrazolo[4,3-c]pyridine
EINECS	Contact for details

Quality Control

Our Trelagliptin is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for pharmaceutical use, including identity, purity, and impurity profile. Certificates of Analysis (COA) are provided, detailing results from tests such as HPLC assay, chiral purity, residual solvents, and heavy metals, in compliance with ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.5%
Chiral Purity (HPLC)	≥ 99.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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