Reactive impurities in pharmaceutical excipients are often overlooked, yet they can have a serious impact on drug product stability and safety.
These impurities can react with the active pharmaceutical ingredient (API), leading to degradation, loss of potency, and in some cases, the formation of toxic degradation products.
Common reactive impurities include peroxides, aldehydes, reducing sugars, organic acids, nitrites, and trace metals.
Each of these can contribute to unwanted reactions such as oxidation, the Maillard reaction, or even the formation of nitrosamines.
Such impurities may vary between vendors and manufacturing batches, which makes early excipient screening during formulation development essential.
Proper vendor qualification, storage control, and analytical testing help ensure consistent quality and minimize risks.
Understanding and controlling reactive impurities is not just a regulatory requirement—it is a crucial step toward ensuring product stability, safety, and patient trust.
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Resource Person: Vijay Agrawal