RT Journal Article
SR Electronic
T1 Optimization of Autoclave Cycles and Selection of Formulation for Parenteral Products, Part II: Effect of Counter-Ion on pH and Stability of Diatrizoic Acid at Autoclave Temperatures
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 72
OP 77
VO 38
IS 2
A1 Wang, Y. J.
A1 Dahl, T. C.
A1 Leesman, G. D.
A1 Monkhouse, D. C.
YR 1984
UL http://journal.pda.org/content/38/2/72.abstract
AB Effect of counter-ions on stability of a drug substance was illustrated in this study. During autoclave sterilization of diatrizoic acid solutions, anilide hydrolysis resulted information of desacetyldiatrizoic acid, a free aromatic amine. Under the same autoclave conditions, more of desacetyldiatrizoic acid was produced in the diatrizoic acid solution neutralized with sodium hydroxide than those neutralized with either meglumine or ammonia. Stability difference in the presence of each counter-ion was attributed to varying pH’s at autoclave temperatures. By using a nonisothermal approach, the kinetic parameters were determined by a nonlinear least square program. This information can be particularly useful when autoclave sterilization cycles are to be optimized.