Description

Ticagrelor Impurity 154 is a designated chemical reference standard used in the pharmaceutical development and quality control of the antiplatelet drug Ticagrelor. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. 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 qualitative and quantitative analysis of Ticagrelor drug substance and drug products.
• Method Development and Validation: Essential for developing and validating robust analytical methods, such as HPLC and UPLC, to monitor impurities.
• Quality Control (QC) Testing: Used in routine QC laboratories to assess the purity of Ticagrelor batches against established specifications.
• Stability Studies: Employed to track the formation of this specific impurity over time under various storage conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity profiling.
• Research and Development: Utilized in R&D to understand the degradation pathways and synthesis by-products of Ticagrelor.

Basic Information

Product Name	Ticagrelor Impurity 154
CAS No.	1643413-85-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ticagrelor Related Compound 154; Ticagrelor Impurity 154; Ticagrelor EP Impurity G; Ticagrelor USP Impurity; (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; AZD6140 Impurity 154
EINECS	Contact for details

Quality Control

Our Ticagrelor Impurity 154 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality requirements.

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 COA. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with specification
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 5.0%

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