Description

Ticagrelor Related Compound 46 is a high-purity chemical reference standard, identified by CAS NO 2205903-73-5. This compound is critical for ensuring the quality, safety, and efficacy of the antiplatelet drug Ticagrelor during its development and manufacturing phases. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and regulatory affairs teams for analytical method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Ticagrelor active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity levels in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Serves as a system suitability standard in routine QC testing to ensure the consistency and purity of manufactured Ticagrelor batches.
• Regulatory Submissions: Provides necessary 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: Employed to track the formation of degradation products in Ticagrelor formulations under various stress conditions (e.g., heat, humidity, light).
• Research & Process Chemistry: Aids in understanding the synthesis pathway and optimizing manufacturing processes to minimize the formation of this related compound.

Basic Information

Product Name	Ticagrelor Related Compound 46
CAS No.	2205903-73-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ticagrelor Impurity 46; Ticagrelor Related Substance 46; Ticagrelor EP Impurity G; Ticagrelor USP Related Compound 46; (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 46
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Each batch of Ticagrelor Related Compound 46 is characterized and qualified using advanced analytical techniques, including HPLC, LC-MS, and NMR, to confirm identity and purity. Certificates of Analysis (COA) are available upon request, providing detailed batch-specific data. Production follows strict quality management systems in line with cGMP principles for pharmaceutical reference standards.

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. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant in the container.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.