RT Journal Article
SR Electronic
T1 Measurement of Solution Composition as an Alternative to Titration for Evaluating the Hydrolytic Resistance of Glass
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2022.012737
DO 10.5731/pdajpst.2022.012737
A1 Susan L Schiefelbein
A1 K Deenamma Vargheese
A1 Robert A Schaut
A1 Ela Bakowska
A1 Misty N Riesbeck
A1 Daniel D Kramer
A1 William H Stull
YR 2023
UL http://journal.pda.org/content/early/2023/06/15/pdajpst.2022.012737.abstract
AB The measurement of solution composition is proposed as an alternative to titration to determine titration volume, which is the figure of merit for evaluating the hydrolytic resistance of glass containers for pharmaceutical packaging. In the new method, instead of titrating the sample and blank solutions, their compositions are measured by inductively coupled plasma mass spectrometry, and these compositions are converted to titration volume using a set of coefficients and a simple equation. The coefficients were derived using the well-developed thermodynamic data and models for dilute aqueous solutions, which make it possible to calculate pH from solution composition and then simulate a titration as a series of pH calculations as titrant is progressively added to the solution. In this paper we explain how a titration can be simulated, describe how the set of coefficients was derived, and provide experimental evidence that the titration volume from the new method is equivalent to that from titration. Since the new method is more difficult and expensive, it is not meant as a replacement for titration in the standard and pharmacopeial methods. Its value lies in enabling previously impossible hydrolytic resistance studies, supplying additional information about the composition of the hydrolytic solution which reveals important aspects of glass corrosion, and providing insights about titration which point to possible improvements in the standard titration procedures.