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The potential sources of impurities in Palbociclib include starting materials, reagents, solvents, degradation products, and processing aids used during manufacturing.
Analytical methods such as HPLC, and LC-MS help identify and quantify Palbociclib impurities.
Impurities in Palbociclib are monitored during stability studies using validated analytical methods to ensure that the drug product remains within the specified limits over the shelf life of the product.
The recommended storage temperature for Palbociclib Impurities is 2-8°C in general. However, it depends upon the stability of the compound.
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