Description

Ticagrelor Related Compound 71 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Ticagrelor, a key antiplatelet medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of this well-characterized related compound is essential for maintaining strict compliance with Good Manufacturing Practice (GMP) and pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling and Control: Serves as a certified reference material for the identification and quantification of specific impurities in Ticagrelor drug substance and finished products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for Ticagrelor analysis.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine QC testing within pharmaceutical manufacturing to monitor batch-to-batch consistency and ensure impurity levels remain within specified limits.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough characterization and control of potential impurities.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies of Ticagrelor to understand its degradation pathways.
• Research and Development (R&D): Facilitates chemical and pharmacological research into the metabolism, synthesis, and properties of Ticagrelor and its related substances.

Basic Information

Product Name	Ticagrelor Related Compound 71
CAS No.	1548397-10-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ticagrelor Impurity 71; Ticagrelor Related Substance 71; Ticagrelor EP Impurity G; Ticagrelor USP Related Compound 71; (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 71
EINECS	Contact for details

Quality Control

Every batch of Ticagrelor Related Compound 71 is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including potential alignment with USP, EP, and ICH guidelines. Comprehensive characterization is performed using advanced analytical techniques. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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