Moisture Validation For PMDIs

Validation of Moisture Determination for Pressurized Metered Dose Inhalers: An Alternative Approach

Authors: Brian N. Woodrow, PhD, Tristan Fairbrother, Tony Ruffin, and Courtney Turner, Catalent

A novel approach was taken to validate a method for the determination of water content in pressurized metered dose inhalers (pMDI) containing a single active and combination therapies. This streamlined version of the traditional approach consisted of determining moisture values of spiked water additions and plotting the data to determine accuracy, linearity, and specificity. Moisture determination was assessed using a Karl Fischer coulometric titrator. The results showed that this approach provides more comprehensive results in a shorter amount of time than the traditional approach.