Buyer questions · Use scenarios
How long must a new formula be tested before a shelf life can be set, and is accelerated data enough?
Accelerated data alone does not set a shelf life. Standard practice combines 40C accelerated for 3 months, 25C real-time for 12 months and 3–5 freeze-thaw cycles to support a 24-month shelf life; a clean 3-month accelerated result is supporting evidence, the real-time data is decisive.
1Accelerated: 40C for three months
Sampled at 0/1/2/3 months for appearance, odour, pH, viscosity and microbiology; a clean result is one of the supports for 24 months.
2Real-time: 25C followed to expiry
25C/60%RH at 0/3/6/12 months and followed through the shelf life; the product must meet its specification throughout.
3Freeze-thaw and light
3–5 cycles between -5C and room temperature, 24 hours each, with no separation on thawing; transparent packs and essential-oil systems add a light study.
Follow-up questions
- Q:Can a provisional shelf life be given at sampling?
- A:Yes, marked provisional on accelerated data; the labelled shelf life waits for real-time coverage.
- Q:Does a packaging change require retesting?
- A:Compatibility must be re-run: product in the actual pack at 40C and room temperature for at least 3 months, watching for leakage, swelling, discolouration and fragrance migration.
Figures sourced from:质检体系 · 稳定性与相容性配方库
Updated 2026-09-16
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