Description

Trelagliptin CAS NO 865759-25-7 is a high-purity, small-molecule active pharmaceutical ingredient (API) belonging to the dipeptidyl peptidase-4 (DPP-4) inhibitor class. It is a critical component in the formulation of advanced oral anti-diabetic medications for the management of type 2 diabetes. This compound is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of novel therapeutics. Its consistent quality and reliable supply are essential for ensuring the efficacy and safety of the final drug product.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of anti-diabetic drugs for the treatment of type 2 diabetes mellitus.
• Drug Formulation R&D: Used in research and development for creating new sustained-release or fixed-dose combination tablets.
• Reference Standard: Serves as a certified reference material (CRM) for quality control and analytical method validation in pharmaceutical laboratories.
• Clinical Trial Material: Supplied as a key component for the production of investigational medicinal products (IMPs) in clinical studies.
• Biochemical Research: Utilized in pharmacological studies to investigate DPP-4 enzyme inhibition mechanisms and metabolic pathways.
• Generic Drug Manufacturing: Essential for companies producing generic versions of DPP-4 inhibitor medications post-patent expiry.

Basic Information

Product Name	Trelagliptin
CAS No.	865759-25-7
Molecular Formula	C₁₈H₂₀FN₅O₂
Molecular Weight	357.38 g/mol
Synonyms	2-({6-[(3R)-3-Aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl}methyl)-4-fluorobenzonitrile; Trelagliptin Succinate; SYR-472; Zafatek; Alogliptin analogue; DPP-4 Inhibitor; (R)-2-((6-(3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)-4-fluorobenzonitrile
EINECS	Contact for details

Quality Control

Our Trelagliptin is manufactured under strict quality management systems, ensuring it meets the stringent requirements for pharmaceutical actives. Each batch is subjected to comprehensive analytical testing, including HPLC for purity, residual solvent analysis, and control of related substances. A Certificate of Analysis (COA) is provided with every shipment, detailing compliance with in-house specifications aligned with ICH guidelines. We support our partners with full traceability and documentation for regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a 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 crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single unknown impurity ≤ 0.2%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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