Description

Ticagrelor Imp.J CAS NO 2248538-63-6 is a high-purity impurity standard, specifically identified as a known process-related impurity of the antiplatelet drug Ticagrelor. This compound is critical for pharmaceutical research and development, serving as a key reference material for analytical method development, validation, and quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Ticagrelor active pharmaceutical ingredients (APIs) and finished drug products.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference standard to identify and quantify Impurity J in Ticagrelor drug substances and products.
• Analytical Method Development and Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating stability-indicating chromatographic methods for Ticagrelor.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to monitor impurity levels against established specifications to ensure compliance with ICH guidelines.
• Stability Studies and Forced Degradation Studies: Acts as a marker to understand the degradation pathways and stability profile of Ticagrelor formulations.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control.
• Research and Development: Supports synthetic chemistry research aimed at optimizing the Ticagrelor manufacturing process to minimize this impurity.

Basic Information

Item	Detail
Product Name	Ticagrelor Impurity J
CAS No.	2248538-63-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ticagrelor Impurity J; Ticagrelor Related Compound J; Ticagrelor EP Impurity J; Ticagrelor USP Impurity J; (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 (Impurity J); AZD6140 Impurity J; Brilinta Impurity J
EINECS	Contact for details

Quality Control

Every batch of Ticagrelor Impurity J (CAS 2248538-63-6) is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is supplied with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles and relevant pharmacopeial guidelines (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. For long-term storage, consider storing desiccated at -20°C. Handle the material carefully to prevent contamination.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 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.