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BIMM118<br />

• Regulatory bodies (FDA)<br />

Drug Quality<br />

– ensure quality of prescribed drugs<br />

• Defined criteria for:<br />

– Purity<br />

– Stability and sterility<br />

– Limits of potentially toxic impurities<br />

– Defined, approved amount of drug, released at a specified rate (United<br />

States Pharmacopoeia, British Pharmacopoeia, European Pharmacopoeia)

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