Analytical methods, such as high-performance liquid chromatography (HPLC), are commonly used to detect and quantify impurities in Ticagrelor batches.

The specifications for Ticagrelor impurities are determined through meticulous research, analysis, and adherence to regulatory guidelines. Essential factors, including toxicological studies, clinical data, and regulatory considerations, are thoroughly evaluated to establish acceptable limits for impurity levels.

A chiral column separation technique helps identify the chiral isomer and employs a self-contrast approach without needing a correction factor to quantify impurities. Experimental results demonstrate that the chosen chromatographic conditions effectively separate the main component and its chiral isomer, allowing for better control over the mass of the Ticagrelor crude drug.

Ticagrelor impurities are stored at a controlled room temperature, between 2-8 °C or as indicated on the Certificate of Analysis (CoA).