Description

Ticagrelor Related Compound 85 is a high-purity chemical reference standard, identified by CAS No. 1628340-74-8. This compound is critically important 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 research, method development, and stringent quality control processes.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material to identify, quantify, and monitor this specific related substance in Ticagrelor API and finished drug products.
• Analytical Method Development and Validation: Essential for developing and validating precise HPLC, UPLC, or LC-MS methods to meet ICH Q3A(R2) and Q3B(R2) guidelines for impurities.
• Quality Control and Batch Release Testing: Serves as a system suitability standard and for preparing calibration curves in routine QC testing to ensure product specifications are met.
• Stability Studies: Employed to track the formation and levels of this impurity during forced degradation and long-term stability studies of Ticagrelor formulations.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Pharmacopoeial Testing: Supports testing against monographs in pharmacopoeias such as USP or EP where control of related compounds is specified.

Basic Information

Product Name	Ticagrelor Related Compound 85
CAS No.	1628340-74-8
Molecular Formula	C23H28F2N6O4S
Molecular Weight	522.57 g/mol
Synonyms	(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 Impurity 85; Ticagrelor Related Substance 85; BRILINTA Impurity 85; AZD6140 Related Compound 85
EINECS	Contact for details

Quality Control

Every batch of Ticagrelor Related Compound 85 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including chromatographic purity and structural confirmation data, is provided with each shipment.

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) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

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 ≤ 0.5% 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.