Description

Ticagrelor Impurity 63 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antiplatelet drug Ticagrelor. It is primarily required by analytical laboratories and pharmaceutical manufacturers for method development, validation, and routine quality control testing. The availability of this well-characterized impurity is essential for meeting stringent pharmacopeial standards and regulatory filings.

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 stability-indicating HPLC/UPLC methods to monitor impurity profiles during drug stability studies.
• Quality Control & Batch Release: Employed in routine QC testing to ensure Ticagrelor batches comply with specified impurity limits as per ICH Q3A/B guidelines.
• Regulatory Compliance & Filings: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during API synthesis, enabling process optimization for impurity minimization.

Basic Information

Item	Detail
Product Name	Ticagrelor Impurity 63
CAS No.	2227766-79-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ticagrelor Related Compound 63; Ticagrelor Impurity C; Ticagrelor EP Impurity C; Ticagrelor USP Impurity; (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 (Impurity); AZD6140 Impurity 63; Brilinta Impurity 63
EINECS	Contact for details

Quality Control

Every batch of Ticagrelor Impurity 63 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identity confirmation by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of residual solvents and moisture. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against predefined specifications. Our quality commitment aligns with ICH Q7 and cGMP principles to ensure consistency and reliability for your critical pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. Keep the container in a dry, cool, and well-ventilated place. For long-term storage under inert atmosphere, please contact our technical team for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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