FOR PHARMACISTS · REFERENCE EDITION 8.0261 monographs · 32 SOPs · 18 forms
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ALG-001 / v2.0

Pistachio syrup

This dossier develops the technical example already published on compounding.gr. It remains a development dossier: no complete analytical protocol, protein-recovery study or dating study for the actual matrix was supplied.

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Development dossier · No validated formula, clinical dosing schedule or established finished-preparation BUD.

Raw-material identity

Record Pistacia vera, origin, lot, nut fraction, thermal processing, milling, moisture and additives or other-nut contamination. Supplier or roasting changes require new comparison. Nutrition-label protein does not establish this finished preparation’s concentration.

Syrup matrix and process

Record sugars, water, final volume/mass, viscosity and dissolved/suspended fractions. Assess material retained on filters and vessels. Heating can alter the protein profile and does not demonstrate allergen inactivation. Sampling before and after critical steps must address a defined analytical question.

Protein and actual withdrawal

Define the analyte linked to the clinical order. Establish method suitability in the sugar matrix, recovery and concentration range. Assess the dosing device, smallest withdrawal and within-container uniformity through use. Do not derive mg protein/mL solely from starting nut mass.

Clinical evidence and transfer limits

NUT CRACKER studied cashew and reported pistachio cross-desensitisation in co-allergic patients. It did not study this syrup recipe, filter, concentration or shelf life. No numerical BUD or dosing regimen is transferred from it.

Use decision

Require a complete specialist order, confirmed strength, uniformity, microbiological quality, preservation, packaging and stability evidence. Without those data, no clinically executable recipe or numerical use-by period is assigned. OIT-001 through OIT-008 and F-008/F-009 define the dossier structure.

Sources and references

  1. EMA — Guideline on Allergen Products: Production and Quality IssuesEMEA/CHMP/BWP/304831/2007, 2008Sections 2, 4.1.1, 4.2.4, 4.3, 4.4.3–4.4.5; pp. 4–13Industrial biological-allergen quality guidance; principles adapted explicitly, not a compounding authorisation or a food-OIT recipe2026-09-12
  2. Santos AF et al. EAACI guidelines on the management of IgE-mediated food allergyAllergy. 2025;80:14–36; online 2024Abstract and published guideline recommendations; DOI 10.1111/all.16345Specialist clinical recommendations; not stability evidence for local syrups or suspensions2026-09-12
  3. Elizur A et al. Cashew oral immunotherapy for desensitizing cashew-pistachio allergy (NUT CRACKER study)Allergy. 2022;77:1863–1872Primary clinical study abstract; DOI 10.1111/all.15212Cashew OIT cohort and pistachio cross-desensitisation; no pistachio syrup or peanut suspension stability data2026-09-12
  4. PIC/S — Guide to Good Practices for the Preparation of Medicinal Products in Healthcare EstablishmentsPE 010-4, 1 March 2014Chapters 1–9; Annex 2 (nonsterile liquids, creams, ointments)Professional quality-system framework; not automatic national legal adoption or certification2026-09-12