Description

Trelagliptin Impurity 1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for quality control and regulatory compliance in the development and manufacturing of the antidiabetic drug Trelagliptin. It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and contract research organizations (CROs) for method validation, impurity profiling, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Trelagliptin Impurity 1 in active pharmaceutical ingredient (API) and finished drug product batches.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor this specific impurity.
• Impurity Profiling and Characterization: Supports comprehensive impurity identification studies required for regulatory filings (e.g., ICH guidelines Q3A(R2) and Q3B(R2)).
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to track the formation of this impurity under various stress conditions.
• Quality Control & Batch Release Testing: Serves as a system suitability standard in routine QC testing to ensure Trelagliptin API meets stringent purity specifications.
• Pharmacopeial Standards: Supports compliance with pharmacopeial monographs where this impurity is specified and controlled.

Basic Information

Product Name	Trelagliptin Impurity 1
CAS No.	1821400-07-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	SYR-472 Impurity 1; Trelagliptin Related Compound 1; (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 Impurity; Trelagliptin EP Impurity A; Trelagliptin USP Impurity; Alogliptin Impurity (structural analog); DPP-4 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Trelagliptin Impurity 1 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis to ensure compliance with ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing all test results, methods, and acceptance criteria is provided with every shipment to support your regulatory and quality requirements.

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 under inert atmosphere or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.