Description

Ticagrelor Impurity 15 is a designated impurity reference standard used in the analytical profiling and quality control of the antiplatelet drug Ticagrelor. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product by accurately identifying and quantifying process-related impurities. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance, and regulatory compliance to meet stringent pharmacopeial standards for drug substance characterization.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Ticagrelor Impurity 15 in active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling of Ticagrelor.
• Quality Control & Assurance (QC/QA): Essential for routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency in Ticagrelor manufacturing.
• Stability Studies: Employed to track the formation of this specific impurity during forced degradation and long-term stability studies of Ticagrelor drug substance and products.
• Regulatory Compliance & Filings: Provides necessary data for regulatory submissions (e.g., to FDA, EMA) to establish impurity thresholds and control strategies as per ICH guidelines.
• Research & Development: Used in process chemistry research to understand and optimize synthesis pathways to minimize the formation of this impurity.

Basic Information

Product Name	Ticagrelor Impurity 15
CAS No.	1643378-48-6
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 15; Ticagrelor EP Impurity G; Ticagrelor USP Impurity; AZD6140 Impurity 15
EINECS	Contact for details

Quality Control

Every batch of Ticagrelor Impurity 15 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure high purity and identity confirmation, aligning with standards relevant for pharmaceutical impurity reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for purity (HPLC), identity (IR, MS), and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity. Keep the container tightly sealed in a cool, dry, and well-ventilated place.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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