Stability and BUD justification

Procedure

1. Compare the studied and local preparations: active, salt, strength, excipients, water, pH, process and container.
2. Assess study quality and whether analysis distinguishes degradation. Preserved appearance alone does not demonstrate chemical stability.
3. Assess chemical, physical and microbiological stability separately, preservative effectiveness where required, and in-use behaviour.
4. Consider current jurisdictional requirements and material limitations. Do not automatically transfer a numerical BUD between sources or countries.
5. In F-006 record the selected period, starting point, temperature, packaging, evidence and limitations. Calculate the actual date for each batch.
6. Reassess after vehicle, supplier, process or container changes and temperature excursions. Do not extend expiry by relabelling without evidence.

Additional detail

This template uses defaults of revised USP <795>, official from 1 November 2023: unpreserved aqueous aw ≥0.60 up to 14 days at 2–8 °C; preserved aqueous up to 35 days at controlled room temperature or refrigeration when compatible; nonaqueous oral liquid aw <0.60 up to 90 days; other nonaqueous forms aw <0.60 up to 180 days, at controlled room temperature or compatible refrigeration. These are category ceilings, not demonstrated stability of each formula or Greek law. A shorter supported limit takes precedence. Do not assign 14 days at room temperature when refrigeration is incompatible.

The clock begins at compounding initiation. Commercial-component expiry remains a constraint. Compounded components generally constrain the final preparation to their shortest BUD; a specific modifier/vehicle exception needs evidence that final chemical, physical and microbiological quality is not adversely affected.

Related forms

F-006