Stasinos Chr. Sikalias · The science of compounding

Batch worksheet: Quetiapine 50 / 100 / 150 mg immediate-release capsules

CGR-FR-034 · Blank fields for controlled execution

For local reviewCGR-FR-034France

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

Quetiapine: main monograph/tables specify fumarate; note has an isolated chlorhydrate reference. Exact monograph composition retained. Extension from 6 to 12 weeks requires the note p.5 conditions.

Quetiapine: main monograph/tables specify fumarate; note has an isolated chlorhydrate reference. Exact monograph composition retained. Extension from 6 to 12 weeks requires the note p.5 conditions.

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-FR-034 · Monograph 4.0 · Web 4.0 · 10.09.2026

Local master ID / versionBatch / date

Materials and actual quantities

MaterialSourceLocal targetActual amountLot / expiry / check
Quetiapine fumarate, for 50 / 100 / 150 mg base57.56 / 115.12 / 172.68 mg
Colloidal anhydrous silica, respectively0.5 / 1 / 1.5 mg
Opaque gelatin shell, size 4 / 2 / 1 respectively1

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