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...
The Ultimate Scientific and Technical Reference
This article is included in
Drugs and pharmaceuticals
This offer includes:
Knowledge Base
Updated and enriched with articles validated by our scientific committees
Services
A set of exclusive tools to complement the resources
Practical Path
Operational and didactic, to guarantee the acquisition of transversal skills
Doc & Quiz
Interactive articles with quizzes, for constructive reading
Quality criteria for therapeutic lyophilisates
Conclusion
Bibliography
Websites
Freeze-drying.eu http://www.freeze-drying.eu
Freeze Drying/Lyophilization Info Online https://www.worldcat.org/title/freeze-dryinglyophilization-of-pharmaceutical-and-biological-products/oclc/664125915
...Directory
Freeze-dryer manufacturers (non-exhaustive list)
CRYOTEC http://www.cryotec.fr
USIFROID http://www.usifroid.com
SERAIL http://www.serail.com
...
The Ultimate Scientific and Technical Reference
