A minimum accelerated stability protocol runs 12 weeks at 40°C and 75% relative humidity, following ICH Q1A guidelines. Real-time stability at 25°C runs concurrently and is expected to cover the full shelf-life claim—typically 24 or 36 months. Including safety assessment, total pre-launch testing can add 5–7 months to your timeline. Finding an experienced formulator via the AJ Cosmo Labs app can help you avoid costly protocol restarts.
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