Description

Ticagrelor Related Compound 15 is a high-purity chemical reference standard, identified by CAS No. 1644461-81-3, which is critical for pharmaceutical research and development. This compound serves as a key impurity or intermediate in the synthesis and quality control of the antiplatelet drug Ticagrelor, ensuring product safety and regulatory compliance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in API development, method validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Ticagrelor Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities and ensure the purity profile of Ticagrelor.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to comply with pharmacopeial standards (USP, EP) and ICH guidelines Q3A(R2) and Q3B(R2).
• Stability Studies: Employed to track the formation of degradation products in Ticagrelor formulations under various stress conditions (heat, light, humidity).
• Process Chemistry & R&D: Used by chemists to study synthetic pathways, optimize manufacturing processes, and control impurity profiles during Ticagrelor synthesis.
• Regulatory Submissions: Provides necessary data and reference materials for regulatory filings (e.g., DMF, CMC sections) with agencies like the FDA and EMA.

Basic Information

Product Name	Ticagrelor Related Compound 15
CAS No.	1644461-81-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ticagrelor Impurity 15; Ticagrelor Related Substance 15; Ticagrelor EP Impurity J; Ticagrelor USP Related Compound 15; (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; AZD6140 Related Compound 15
EINECS	Contact for details

Quality Control

Our Ticagrelor Related Compound 15 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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 desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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