Description

Ticagrelor Related Compound 93 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of Ticagrelor, a key antiplatelet medication, by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control processes.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Ticagrelor active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Essential for developing and validating High-Performance Liquid Chromatography (HPLC) and Ultra-High-Performance Liquid Chromatography (UHPLC) methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity profiles and stability data for drug master files (DMFs).
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor the formation of related substances in Ticagrelor formulations.
• Pharmacopoeial Testing: Used to comply with monograph specifications in pharmacopoeias such as USP (United States Pharmacopeia) and EP (European Pharmacopoeia).
• Research & Development: Serves as a critical tool in synthetic chemistry R&D for route scouting, process optimization, and impurity characterization.

Basic Information

Item	Details
Product Name	Ticagrelor Related Compound 93
CAS No.	2207528-55-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ticagrelor Impurity 93; Ticagrelor Related Substance 93; Ticagrelor EP Impurity J; Ticagrelor USP Related Compound; (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 (Related Compound); AZD6140 Related Compound 93; Brilinta Impurity 93
EINECS	Contact for details

Quality Control

Every batch of Ticagrelor Related Compound 93 is manufactured under strict quality management systems and undergoes comprehensive analytical testing. Our quality control protocols are designed to meet the stringent requirements of pharmaceutical reference standards, ensuring high purity, accurate identification, and precise quantification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis. We support compliance with cGMP, ICH Q3A/B guidelines, and major pharmacopoeial standards (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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