Description

Trelagliptin Impurity 20 is a high-purity chemical reference standard used for the analytical profiling and quality control of the antidiabetic active pharmaceutical ingredient, Trelagliptin. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure drug safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance, and analytical chemistry for method development and validation.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Trelagliptin drug substance and drug products.
• Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) to separate and detect impurities.
• Quality Control (QC) Testing: Used in routine QC laboratories to monitor impurity levels against International Council for Harmonisation (ICH) guidelines in finished APIs and formulations.
• Stability Studies: Employed to identify and track degradation products that may form under various stress conditions during drug shelf-life studies.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity profiles and justify specification limits.
• Research & Development: Aids in understanding the degradation pathways and chemical behavior of Trelagliptin during synthesis and formulation processes.

Basic Information

Product Name	Trelagliptin Impurity 20
CAS No.	1821520-42-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Trelagliptin Related Compound 20; Trelagliptin Impurity; SYR-472 Impurity; 2-({6-[(3R)-3-Aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl}methyl)-4-fluorobenzonitrile; Alogliptin Impurity 20 (Note: Verify structural identity); DPP-4 Inhibitor Impurity; 1-[(4-Fluoro-2-cyanophenyl)methyl]-3-methyl-6-[(3R)-3-aminopiperidin-1-yl]pyrimidine-2,4(1H,3H)-dione
EINECS	Contact for details

Quality Control

Our Trelagliptin Impurity 20 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality 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. The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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