Stasinos Chr. Sikalias · The science of compounding

Batch worksheet: Menthol spirit 5% w/v PO012

CGR-ES-064 · Blank fields for controlled execution

For local reviewCGR-ES-064Spain · AEMPS

WORKSHEET FOR LOCAL APPROVAL — source authority does not replace batch approval.

Inhalation directions differ between main text and leaflet. This adaptation covers cutaneous use only.

Inhalation directions differ between main text and leaflet. This adaptation covers cutaneous use only.

Companion batch worksheet. Use with the full monograph and a locally approved master record. This is not a standalone recipe. Complete by hand after printing.

Full monograph PDF

CGR-ES-064 · Monograph 4.0 · Web 4.0 · 10.09.2026

Local master ID / versionBatch / date

Materials and actual quantities

MaterialSourceLocal targetActual amountLot / expiry / check
Racemic menthol5 g
Ethanol 96%q.s. ad 100 mL

Local batch size, units, calculations and independent check

Line clearance, equipment, calibration and cleaning

Stages, times, actual parameters and observations

Yield, losses and reconciliation

QC: samples, methods, limits and actual results

Deviations, investigation and decision

Packaging, label, storage and actual BUD justification

Operator, reviewer and releasing pharmacist — signatures / dates