Description

Trelagliptin Impurity F is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Trelagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of Trelagliptin Impurity F in drug substance and finished product analysis.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing in pharmaceutical manufacturing to monitor and control impurity levels as per ICH guidelines.
• Regulatory Compliance & Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Employed to track the formation and behavior of this specific impurity under various stress conditions and over the product's shelf life.
• Research & Development (R&D): Used in synthetic chemistry and process research to understand impurity formation pathways and optimize synthesis routes.

Basic Information

Product Name	Trelagliptin Impurity F
CAS No.	1917324-14-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(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; Trelagliptin Related Compound F; SYR-472 Impurity F; Alogliptin Impurity F (related); DPP-4 Inhibitor Impurity Standard
EINECS	Contact for details

Quality Control

Our Trelagliptin Impurity F is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization via NMR and MS, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and chromatographic data is provided with every shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The product should be kept in a dry environment and handled with appropriate laboratory safety practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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