Stasinos Chr. Sikalias · The science of compounding

Batch worksheet: Hydroalcoholic vehicle 2 EX027

CGR-ES-059 · Blank fields for controlled execution

For local reviewCGR-ES-059Spain · AEMPS

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

70 mL of 96% ethanol and 30 mL water are input volumes. The source is not changed to q.s. ad 100 mL.

70 mL of 96% ethanol and 30 mL water are input volumes. The source is not changed to q.s. ad 100 mL.

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-059 · Monograph 4.0 · Web 4.0 · 10.09.2026

Local master ID / versionBatch / date

Materials and actual quantities

MaterialSourceLocal targetActual amountLot / expiry / check
Ethanol 96%70 mL
Purified water30 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