5. Quality criteria for therapeutic lyophilisates
In order to market the product, the freeze-drying cycle must be validated, by inspecting the freeze-dried product for certain criteria, which must meet set standards. The most important of these in the pharmaceutical field are listed below.
These standards vary according to the active ingredient (e.g. color, dissolution time, etc.) and are set by laboratories in specifications.
5.1 Physical state of lyophilisate
The physical state of the product depends essentially on the freezing phase, which results in a dry product in a crystalline or amorphous state. Either form may affect the reconstitution procedure and/or the drug's solubility. The stability of the active ingredient during storage generally...
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Quality criteria for therapeutic lyophilisates
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