In this study, we systematically investigated changes in the crystal structure and key quality indicators of nanoparticulate aluminum hydroxide adjuvants under various storage temperature conditions. By providing valuable insights into the effects of storage on adjuvant quality, this research offers practical guidance for optimizing storage conditions and ensuring the safe and effective production of vaccines.
These findings highlighted the remarkable adsorption efficiency of nanoparticle aluminum hydroxide adjuvants throughout storage, reinforcing their potential as superior vaccine adsorbents.
However, higher storage temperatures accelerate the aging process and facilitate the formation of highly crystalline phases such as gibbsite or bayerite, which undermines the stability and quality of the adjuvant. The optimal storage temperature for aluminum hydroxide adjuvants is 2–8 °C, as this range preserves the stability of the crystal structure for at least 6 months while minimizing reductions in pH and pI.
Yang, X.F. et al. / J. Chin. Pharm. Sci. 2025, 34 (10), 911–920.
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