Description

Ticagrelor Related Compound 44 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 quality control testing. The availability of a well-characterized related compound is essential for maintaining stringent pharmacopeial compliance and product integrity.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Ticagrelor API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for stability-indicating assays.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and pharmacopeial monographs (USP, EP).
• 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), and New Drug Application (NDA) filings to health authorities like the FDA and EMA.
• Research & Development: Facilitates studies on the metabolism, degradation pathways, and synthesis of Ticagrelor and its analogs.

Basic Information

Product Name	Ticagrelor Related Compound 44
CAS No.	1431867-40-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ticagrelor Impurity 44; Ticagrelor Related Substance 44; Ticagrelor EP Impurity C; Ticagrelor USP Related Compound C; (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 Isomer); BRILINTA Related Compound 44; AZD6140 Related Compound 44
EINECS	Contact for details

Quality Control

Our Ticagrelor Related Compound 44 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results and confirming compliance with relevant standards. Our quality commitment ensures material suitable for the most demanding pharmaceutical and regulatory applications.

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 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 (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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