Description

Ticagrelor Impurity 155 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the purity, safety, and efficacy of the antiplatelet drug Ticagrelor during its development and manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and quality control laboratories for method validation, stability studies, and regulatory compliance. The availability of a well-characterized impurity standard is essential for maintaining the highest quality standards in active pharmaceutical ingredient (API) production.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material to identify and quantify this specific impurity in Ticagrelor API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for Ticagrelor analysis.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to monitor impurity levels against International Council for Harmonisation (ICH) guidelines to ensure batch-to-batch consistency.
• Stability Studies: Used to track the formation of this impurity under various stress conditions (heat, light, humidity) to establish shelf-life and proper storage conditions for the drug substance.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to demonstrate comprehensive impurity control.
• Research and Development: Facilitates studies on the degradation pathways and chemical behavior of Ticagrelor during synthesis and formulation processes.

Basic Information

Product Name	Ticagrelor Impurity 155
CAS No.	1391594-37-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ticagrelor Related Compound 155; Ticagrelor Impurity; AZD6140 Impurity 155; (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 Degradant; Ticagrelor Process Impurity; Ticagrelor Specified Impurity
EINECS	Contact for details

Quality Control

Our Ticagrelor Impurity 155 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced chromatographic and spectroscopic methods. We support compliance with ICH Q3A, Q3B, and Q6A guidelines, and our quality commitment aligns with cGMP standards for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
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.