Description

Trelagliptin Impurity Yyj is a high-purity reference standard used in the analytical profiling and quality control of the antidiabetic drug Trelagliptin. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety and regulatory compliance by accurately identifying and quantifying related substances. It serves as an essential tool for method development, validation, and stability studies within the pharmaceutical industry.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Trelagliptin API and finished dosage forms.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for pharmaceutical quality control laboratories.
• Used in stability studies and forced degradation studies to monitor impurity profiles over time.
• Essential for regulatory submissions (e.g., ANDA, NDA) to demonstrate thorough impurity characterization as per ICH guidelines.
• Supports research and development of Trelagliptin synthesis processes and purification strategies.
• Utilized by contract research organizations (CROs) and testing laboratories offering analytical services.

Basic Information

Product Name	Trelagliptin Impurity Yyj
CAS No.	1938080-43-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Trelagliptin Related Compound Yyj; Trelagliptin Impurity; (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; UNII-YYJ; Trelagliptin EP Impurity Y; Trelagliptin USP Impurity; Trelagliptin Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Trelagliptin Impurity Yyj is manufactured and handled under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Comprehensive characterization is performed using advanced analytical techniques, and a Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment to support your regulatory and research needs.

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 must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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