Description

Ticagrelor Related Compound 4 is a high-purity chemical reference standard, essential for analytical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Ticagrelor through precise impurity profiling. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance testing.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Ticagrelor drug substance and finished products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for purity analysis.
• Quality Control (QC) & Quality Assurance (QA): Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency in API manufacturing.
• Stability Studies: Used to track the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and ICH guidelines.
• Research & Development: Facilitates process chemistry research to understand and minimize impurity formation during Ticagrelor synthesis.

Basic Information

Product Name	Ticagrelor Related Compound 4
CAS No.	1446475-48-4
Molecular Formula	C23H28F2N6O4S
Molecular Weight	522.57 g/mol
Synonyms	1,2,3,5-Tetrahydro-3-[7-[[(1R,2S)-2-(3,4-difluorophenyl)cyclopropyl]amino]-5-(propylthio)-3H-1,2,3-triazolo[4,5-d]pyrimidin-3-yl]-4-(2-hydroxyethoxy)cyclopentane-1,2-diol; Ticagrelor Impurity 4; Ticagrelor Related Substance 4; Ticagrelor EP Impurity D; Ticagrelor USP Related Compound D; BRILINTA Impurity D; AZD6140 Related Compound 4
EINECS	Contact for details

Quality Control

Our Ticagrelor Related Compound 4 is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR, MS), and residual solvent analysis, to ensure compliance with ICH Q3A, Q3B, and relevant pharmacopoeial standards (USP, EP). A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

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: ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.