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March 23-26, 2026
New York City
Stability Conditions
by Target Market
We run ICH‑aligned standard conditions, plus cold‑chain and specialized studies, to match your product’s storage, distribution, and target markets.
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Long‑Term
25°C / 60% RH long‑term studies generate the core data package used to support shelf life and labeled storage conditions for temperate markets.
Intermediate
30 °C / 65% RH intermediate studies are conducted only if a significant change occurs at accelerated conditions, to provide reliable support for shelf‑life.
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Zone IV‑B
30°C / 75% RH supports programs intended for hot/high‑humidity regions, defined as a long‑term condition.
Accelerated
40°C / 75% RH accelerated studies help characterize stability trends earlier and support risk‑based decisions during development and registration planning.
Cold‑Chain
Cold condition studies (2–8 °C) demonstrate stability for products intended for refrigerated storage, where higher temperatures would accelerate degradation without reflecting actual use conditions.
Frozen Conditions
−20°C conditions are available for highly sensitive products requiring frozen storage, to prevent degradation or maintain stability that cannot be achieved at higher temperatures.
Compliant Stability programs
Our in‑house laboratory executes chemistry and microbiology stability testing and integrates long‑term and accelerated studies across development, scale‑up, and commercial manufacturing.
Stability Program Design
We build protocols around dosage form, packaging, and target markets. We align conditions to established stability expectations and expiry dating needs.
Trend Review
We review results across all time points and conditions to identify meaningful trends early. Findings are documented and used to support expiry dating and storage decisions.
Stability Summary Reporting
We compile conditions, time points, results, and conclusions in one report. Summaries are structured to support regulatory documentation and storage statements.