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Excipients
Inactive ingredients that ensure drug product quality and performance
Two primary classifications of stability
Physical, non-covalent changes to the product components
Chemical, changes to covalent bonding of the product components
How can physical instability arise?
Changes in phase, i.e. soluble components becoming insoluble components
How can physical instability manifest?
Precipitation, changes in pH may change drug solubility leading to this
Buffers
A form of excipients that are designed to maintain the solution at at constant pH