Description

Ticagrelor Impurity E is a specified impurity of the antiplatelet drug Ticagrelor, a critical component for ensuring the quality and safety of the active pharmaceutical ingredient (API). This compound is essential for pharmaceutical research, development, and quality control laboratories to monitor, identify, and quantify impurities during drug substance manufacturing. It is primarily used by analytical chemists and quality assurance professionals in the pharmaceutical industry for method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the qualitative and quantitative analysis of Ticagrelor.
• Method Development and Validation: Used to develop, optimize, and validate analytical methods, particularly HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): A critical tool for in-process testing and release testing of Ticagrelor API batches to ensure compliance with ICH guidelines.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and control strategies.
• Research and Development: Used in synthetic chemistry research to understand impurity formation pathways and optimize purification processes.

Basic Information

Product Name	Ticagrelor Impurity E
CAS No.	1402150-34-8
Molecular Formula	C23H28F2N6O4S
Molecular Weight	522.57 g/mol
Synonyms	(1S,2S,3R,5S)-3-[7-[[(1R,2S)-2-(3,4-Difluorophenyl)cyclopropyl]amino]-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol; Ticagrelor Related Compound E; Ticagrelor EP Impurity E; Ticagrelor USP Impurity E; BRILINTA Impurity E; AZD6140 Impurity E
EINECS	Contact for details

Quality Control

Every batch of Ticagrelor Impurity E is manufactured under strict quality management systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality control protocols are designed to meet the stringent requirements of pharmaceutical impurity standards, with testing typically including HPLC purity, related substances, residual solvents, and confirmation of structure by spectroscopic methods. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with each shipment.

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
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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