Thursday, April 15, 2021

Elemental Impurities in Pharmaceutical Products



 Elemental impurities in drug substance and drug products may arise from several sources; they may be residual catalysts that were added intentionally in the synthesis or may be present as impurities (e.g., through interactions with processing equipment or container/closure systems or by being present in components of the drug product). Elemental impurities do not provide any therapeutic benefit to the patient, their levels in the drug product should be controlled within acceptable limits. Long term exposure even to low concentrations of impurities can cause many adverse health effects and even toxicity.

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