Stasinos Chr. Sikalias · The science of compounding
Pistachio syrup
Pistacia vera · Sikalias Pharmacy technical dossier
Status: development and quality-assessment dossier. It is not published as a validated process, authorised therapeutic product or one of the 253 bibliographic monographs.
This example arises from the Sikalias Pharmacy laboratory work described by Stasinos Chr. Sikalias. Prior process descriptions are not accompanied here by a complete analytical dossier, protein-recovery study or stability study. Consequently no numerical BUD or administration schedule is assigned.
Before approving a master record
- Confirmed specialist order and exact concentration basis.
- Identity of Pistacia vera, lot, processing and analytical suitability of the raw material.
- For the syrup: document the sugar matrix, water, viscosity, suspended/dissolved fractions and the effect of processing on the analyte.
- Assessment of the effect of temperature and any filtration on recovery.
- Suitable protein/analyte testing of the final product and representative withdrawals.
- Microbiology, packaging compatibility, in-use evidence and BUD justification.
What appearance cannot establish
Uniform appearance does not establish uniform protein. Filtration does not merely make a product “cleaner”: it may change its composition. Heating does not demonstrate allergen neutralisation or sterilisation.
Dossier forms
- F-008 · Allergen raw-material dossier
- F-009 · Allergen process verification
- F-005 · Sampling and QC results
- F-006 · Stability and BUD rationale
- F-010 · Allergen traceability and handover