Description

Trelagliptin Impurity 17 is a designated impurity standard used in the pharmaceutical development and quality control of Trelagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves 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 as a critical component in developing and validating chromatographic methods for impurity profiling.
• Quality Control & Batch Release: Essential for establishing impurity limits and ensuring batch-to-batch consistency in commercial manufacturing.
• Stability Studies: Employed to monitor the formation and levels of this specific impurity under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and optimize synthesis processes for Trelagliptin.

Basic Information

Product Name	Trelagliptin Impurity 17
CAS No.	865759-02-0
Molecular Formula	C18H20FN5O2
Molecular Weight	365.39 g/mol
Synonyms	(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)-3,6-dihydro-2H-pyran; Trelagliptin Related Compound 17; SYR-472 Impurity 17; 7-[(3R,5S)-5-(2,5-Difluorophenyl)-3,6-dihydro-2H-pyran-2-yl]-2-methylsulfonyl-5,6,7,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrazine; Trelagliptin EP Impurity G; Trelagliptin USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Trelagliptin Impurity 17 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests such as HPLC purity, NMR, and mass spectrometry for full traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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