Description

Trelagliptin Impurity Y CAS NO 1938080-42-2 is a high-purity chemical reference standard used in the analytical profiling of the antidiabetic drug Trelagliptin. This compound is critical for pharmaceutical research and development, serving as a key marker for monitoring and controlling the quality and purity of the active pharmaceutical ingredient (API). It is an essential tool for analytical chemists and quality control laboratories in the pharmaceutical industry, enabling precise method development, validation, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quantitative and qualitative analysis of Trelagliptin API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to establish, optimize, and validate chromatographic methods for impurity profiling and stability studies.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure drug substance and product meet stringent purity specifications per ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing definitive identification and quantification of specified impurities.
• Stability Studies: Acts as a benchmark to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Pharmacopoeial Testing: Used for compliance testing against monographs in pharmacopoeias such as USP, EP, or JP where Trelagliptin is listed.

Basic Information

Product Name	Trelagliptin Impurity Y
CAS No.	1938080-42-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(2R)-2-[(6-Chloro-3-methyl-2,4-dioxo-3,4-dihydro-2H-pyrimidin-1-yl)methyl]-4-fluoro-benzonitrile; Trelagliptin Related Compound Y; Trelagliptin Impurity 2; Alogliptin Impurity Y; 1-[(2R)-2-(4-Fluoro-2-cyanophenyl)methyl]-6-chloro-3-methylpyrimidine-2,4-dione; SYR-472 Impurity Y; 1938080-42-2
EINECS	Contact for details

Quality Control

Our Trelagliptin Impurity Y is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination, spectroscopic identification (IR, NMR, MS), and residual solvent analysis to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided, confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines.

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 Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere if the compound is determined to be easily oxidized.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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