Description

Ticagrelor Related Compound 8 is a high-purity chemical reference standard, essential for pharmaceutical research and development. This compound serves as a critical impurity marker and analytical standard for ensuring the quality and safety of the antiplatelet drug Ticagrelor. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control processes. The availability of this well-characterized standard is fundamental for maintaining compliance with stringent pharmacopeial requirements.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Ticagrelor active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure drug substance and product specifications are met.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of Ticagrelor.
• Research & Development: Utilized in synthetic chemistry research for process optimization and impurity synthesis studies related to Ticagrelor manufacturing.

Basic Information

Product Name	Ticagrelor Related Compound 8
CAS No.	378236-67-0
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 8; Ticagrelor Related Substance 8; Ticagrelor EP Impurity H; BRILINTA Impurity 8; AZD6140 Related Compound 8
EINECS	Contact for details

Quality Control

Our Ticagrelor Related Compound 8 is manufactured under strict quality systems and undergoes rigorous analytical testing. Each batch is characterized and released with a comprehensive Certificate of Analysis (COA) that includes data for identity, purity, and impurity profile. The quality standards are designed to meet the requirements for pharmaceutical reference standards, supporting compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines (USP, EP). Certificates of Analysis are available for every lot upon request.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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 unknown impurity ≤ 0.10% Total impurities ≤ 1.0%
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.