Description

Ticagrelor Related Compound 65 is a high-purity chemical reference standard, specifically identified as a process-related impurity or degradation product of the antiplatelet drug Ticagrelor. This compound is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of impurities to ensure drug safety and efficacy. It is primarily required by analytical laboratories, quality control units, and R&D departments within the pharmaceutical and fine chemical industries for method development, validation, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ticagrelor impurities in active pharmaceutical ingredient (API) and finished drug product testing.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor process-related impurities.
• Quality Control & Assurance: Serves as a critical benchmark in QC laboratories to ensure Ticagrelor batches meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity profiles.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of specific degradation products over time.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive understanding and control of the drug substance's impurity profile.
• Research on Degradation Pathways: Used in academic and industrial research to elucidate the chemical degradation pathways of Ticagrelor.

Basic Information

Product Name	Ticagrelor Related Compound 65
CAS No.	2205903-72-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ticagrelor Impurity 65; Ticagrelor Related Substance 65; Ticagrelor Degradant 65; (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 Related Compound 65; Brilinta Impurity 65; (1S,2S,3R,5S)-3-[7-[[(1R,2S)-2-(3,4-Difluorophenyl)cyclopropyl]amino]-5-(propylthio)-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol
EINECS	Contact for details

Quality Control

Our Ticagrelor Related Compound 65 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, impurity profile, and analytical data, supporting compliance with ICH Q3A/B and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccants or inert atmosphere.

Specification

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