Description

Trelagliptin Impurity CAS NO 77532-85-5 is a high-purity reference standard used in the analytical development and quality control of the antidiabetic drug Trelagliptin. This compound is critical for pharmaceutical manufacturers and research laboratories to identify, quantify, and monitor process-related impurities, ensuring the safety and efficacy of the final drug product. It is an essential material for professionals engaged in method validation, stability studies, and regulatory compliance within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of specific impurities in Trelagliptin active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure Trelagliptin drug substances and products meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Acts as a marker to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug stability and shelf-life determination programs.
• Regulatory Submissions: Provides essential data and characterization for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies for Trelagliptin.
• Research & Development: Utilized in synthetic chemistry research to study impurity formation pathways and to develop optimized, cleaner manufacturing processes for Trelagliptin.

Basic Information

Product Name	Trelagliptin Impurity
CAS No.	77532-85-5
Molecular Formula	C18H20FN5O2
Molecular Weight	365.39 g/mol
Synonyms	(2R)-1-[(3R)-3-Amino-4-(2,4,5-trifluorophenyl)butanoyl]-3-(trifluoromethyl)-5,6-dihydro-1H,3H-pyrrolo[1,2-c][1,3]thiazole-6-carboxylic acid; Trelagliptin Related Compound; Trelagliptin Process Impurity; (6R)-1-[(3R)-3-Amino-4-(2,4,5-trifluorophenyl)butanoyl]-3-(trifluoromethyl)-5,6-dihydro-1H,3H-pyrrolo[1,2-c][1,3]thiazole-6-carboxylic acid; SYR-472 Impurity
EINECS	Contact for details

Quality Control

Every batch of Trelagliptin Impurity (CAS 77532-85-5) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 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 (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
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% w/w

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