Description

Trelagliptin Impurity Jyj is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes of the antidiabetic drug Trelagliptin. This impurity is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification, quantification, and monitoring during manufacturing. It is an essential material for analytical laboratories, quality assurance departments, and research institutions focused on method development and regulatory compliance for DPP-4 inhibitor therapeutics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Trelagliptin Impurity Jyj in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in compliance with ICH guidelines.
• Quality Control & Assurance: Used in routine batch release testing to monitor impurity profiles and ensure drug substance and product specifications are met.
• Stability Studies: Employed as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of Trelagliptin.
• Regulatory Submissions: Provides essential data for impurity characterization reports required by regulatory authorities such as the FDA, EMA, and PMDA.
• Research & Development: Supports process chemistry research to understand and minimize the formation of this impurity during synthesis.

Basic Information

Product Name	Trelagliptin Impurity Jyj
CAS No.	2088203-83-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Trelagliptin Related Compound Jyj; Trelagliptin EP Impurity J; Trelagliptin USP Impurity J; Trelagliptin Process 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 Benzoate Impurity Jyj (Note: Verify structural relationship); DPP-4 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Trelagliptin Impurity Jyj is manufactured and handled under strict quality management systems. The product undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on purity, impurities, and chromatographic profiles. Our quality systems are designed to support compliance with cGMP and relevant ICH guidelines for impurities in new drug substances (Q3A(R2)).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing desiccated at 2-8°C. Handle the material under appropriate laboratory conditions to prevent contamination.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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