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4120656 
Technical Report 
Preservation of sodium bisulfite in parenteral solutions of dexamethasone sodium phosphate 
Portnoff, JB; Henley, MW; Polli, GP 
1973 
IPA/74/113041 
Parenteral Drug Assoc 
REF 7 
English 
IPA COPYRIGHT: ASHP A physical instability, encountered in a parenteral dexamethasone sodium phosphate product which was demonstrated to be a function of sodium bisulfite content, is discussed. The causes for loss of sodium bisulfite were investigated. Established remedies for preserving sodium bisulfite such as inert gas flushing, elimination of copper ion contamination, or addition of disodium edetate to the formulation did not solve the problem. The source of water did have a minor effect in maintaining sodium bisulfite levels. Packaging was found to play the key role in sodium bisulfite loss. An empirical method was developed for determining the proper package size for preserving sodium bisulfite based on an ""R" value, or cc. of air/ml. of product, which is independent of any loss due to interaction of the preservative with other components of the formulation.