Description

Trelagliptin Impurity 5 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the antidiabetic drug Trelagliptin. This impurity is critical for ensuring drug safety and efficacy by enabling accurate identification, quantification, and monitoring during the manufacturing process. It is an essential material for analytical laboratories, regulatory affairs, and R&D departments within the global pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for method development and validation in HPLC and LC-MS analysis.
• Quality Control & Assurance: Critical for establishing impurity profiles, setting specifications, and ensuring batch-to-batch consistency of Trelagliptin API (Active Pharmaceutical Ingredient).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Used to monitor the formation and growth of this specific impurity under various stress conditions to determine drug shelf life.
• Process Chemistry R&D: Aids in the identification and control of this impurity during the optimization of Trelagliptin synthesis and purification processes.
• Pharmacopoeial Testing: Employed in testing to comply with pharmacopoeial monographs (e.g., USP, EP) that specify impurity limits for Trelagliptin.

Basic Information

Product Name	Trelagliptin Impurity 5
CAS No.	2087874-92-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	UNII-6H7K2F6P3T; Trelagliptin Related Compound 5; (2R,3S,5R)-2-(2,5-Difluorophenyl)-5-(2-methylsulfonyl-5,6,7,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrazin-7-yl)tetrahydro-2H-pyran-3-amine; Trelagliptin EP Impurity D; Trelagliptin USP Impurity D; SYR-472 Impurity 5; Zafatek Impurity 5
EINECS	Contact for details

Quality Control

Our Trelagliptin Impurity 5 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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