Methodology and use of the Formulary

Completing the reference review means that the text has an explicit decision and scope of use. It does not mean that aw, assay, microbiological quality or stability were measured in an actual batch. Use is governed by each monograph’s decision.

Water content, room humidity, hygroscopicity and sucrose percentage are not aw measurements. Where dating depends on an aw category, appropriate evidence for the exact finished composition is required. No value or category is invented.

A finished batch BUD is not calculated from scaling, raw-material expiry dates or a general table without its applicability conditions. Use evidence for the exact composition and match the container, process and temperature. Without the required evidence, the monograph’s explicit restrictive decision applies.

For eligible reference formulations the calculator scales proportional quantities only, using exact rational arithmetic. Mass and volume remain separate dimensions. It does not select dose or strength, correct for assay, validate mixing or assign a BUD. Fractional tablet/capsule quantities are not rounded.

The responsible pharmacist confirms actual raw materials, equipment, container, analytical capability, requirements and patient suitability. Local approvals and results are recorded using the relevant SOPs and forms. Blank templates are not signed evidence.