Some active pharmaceutical ingredients are classified as high potency. Special precautions are required in the manufacturing, transport and storage of these compounds.
Criteria for a high-potency active pharmaceutical ingredient (HPAPI) – one or more of the following:
(1) occupational exposure limit <= 10 micrograms per cubic meter of air as an 8-hour time-weighted average
(2) daily therapeutic dose <= 10 mg (< 150 micrograms per kg body weight)
(3) daily dose causing serious toxicity in laboratory animal <= 1 mg per kg
(4) high selectivity when binding to a specific receptor or inhibiting a specific enzyme
(5) potential of a low dose to cause cancer, mutation, developmental defect or reproductive toxicity
(6) compound of unknown toxicity and/or potency
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