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Area of Science:

  • Pharmaceutical analysis
  • Vaccine quality control
  • Analytical chemistry

Background:

  • Aluminum hydroxide is a common adjuvant in vaccines.
  • Current methods for quantifying aluminum hydroxide can be time-consuming and require reagents.
  • There is a need for faster, more efficient analytical techniques in vaccine production.

Purpose of the Study:

  • To develop and validate a novel, non-destructive, high-throughput spectrophotometric method for aluminum hydroxide quantification in vaccines.
  • To assess the robustness and performance of the new method against established release testing procedures.

Main Methods:

  • A spectrophotometric principle was employed for aluminum hydroxide quantification.
  • The method was validated using a MenB vaccine and compared against ethylenediaminetetraacetic acid (EDTA) titration.
  • Factors such as well-plate variations, sedimentation, and batch differences were evaluated for method robustness.

Main Results:

  • The novel spectrophotometric method produced results comparable to the official potentiometric release method.
  • The method demonstrated high precision, accuracy, linearity, and specificity.
  • A simple calibration curve allowed for rapid sample measurement in 96-well plates.

Conclusions:

  • A novel, fast, and automatable spectrophotometric method for aluminum concentration determination in alum-adjuvanted vaccines has been successfully developed.
  • This method is as precise and accurate as existing release methods.
  • The technique holds potential as a reliable release test for aluminum-containing pharmaceutical products.