Refers to the physico-chemical condition of a parenteral or biological, or the shelf life of other drugs. A compound or pharmaceutical formulation is said to be stable if it is not reactive under certain conditions such as temperature, humidity, light, etc. Certain drugs must pass USP or CFR stability tests. Manufacturers must have documentation of potency of products under labeled storage conditions.
Glossary
Stability
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Ampoule (Ampule)
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HME
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Validation
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APIs
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Toxicology
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GDUFA
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Inspections
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Capsules
Microcapsule
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Wurster Process
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