Description

Trelagliptin Impurity X CAS NO 1938080-44-4 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the antidiabetic drug Trelagliptin. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Trelagliptin active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure Trelagliptin meets stringent pharmacopeial (e.g., USP, EP, ICH) specifications for impurity limits.
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Essential for preparing compliant documentation for regulatory agencies (FDA, EMA, etc.), including drug master files (DMFs) and investigational new drug (IND) applications.
• Research and Development (R&D): Utilized in synthetic chemistry research to understand impurity formation pathways and to develop robust purification processes.

Basic Information

Product Name	Trelagliptin Impurity X
CAS No.	1938080-44-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Trelagliptin Related Compound X, Trelagliptin EP Impurity X, Trelagliptin USP Impurity X, SYR-472 Impurity X, (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)-3-(trifluoromethyl)-3,4-dihydro-2H-pyrano[2,3-b]pyridine, Alogliptin Impurity X (Note: Trelagliptin is also known as SYR-472, a close analog of Alogliptin), DPP-4 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Trelagliptin Impurity X is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (NMR, MS). We provide comprehensive Certificates of Analysis (COA) with batch-specific data, ensuring traceability and compliance with ICH Q3A/B and current pharmacopeial guidelines. Our quality commitment supports your regulatory and research requirements.

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. For long-term storage, consider storing desiccated at -20°C. Handle with appropriate personal protective equipment in a well-ventilated laboratory setting.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (NMR/MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% 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.