Description

Trelagliptin Impurity Sj CAS NO 2087874-94-8 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of specific impurities in Trelagliptin drug substances and products. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical development and manufacturing, ensuring product safety and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of Trelagliptin Impurity Sj in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control and Release Testing: Employed in routine QC laboratories to ensure Trelagliptin batches meet stringent purity specifications set by pharmacopeias (e.g., USP, EP) and regulatory filings.
• Stability Studies: Used to monitor the formation and levels of this specific impurity during forced degradation and long-term stability studies of Trelagliptin formulations.
• Regulatory Submissions: Provides essential data and reference material for regulatory documentation required by agencies such as the FDA, EMA, and PMDA.
• Research and Development: Facilitates research into the degradation pathways, synthesis, and chemical behavior of Trelagliptin and related compounds.

Basic Information

Product Name	Trelagliptin Impurity Sj
CAS No.	2087874-94-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Trelagliptin Related Compound Sj; Trelagliptin Impurity J; Trelagliptin EP Impurity Sj; Trelagliptin USP Impurity Sj; (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; UNII-7F8Q6J7J4R; 2087874-94-8; Trelagliptin Degradant Sj
EINECS	Contact for details

Quality Control

Every batch of Trelagliptin Impurity Sj is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, LC-MS, NMR, and IR to ensure compliance with high-purity reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
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.