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HERO ID
4120656
Reference Type
Technical Report
Title
Preservation of sodium bisulfite in parenteral solutions of dexamethasone sodium phosphate
Author(s)
Portnoff, JB; Henley, MW; Polli, GP
Year
1973
Report Number
IPA/74/113041
Volume
Parenteral Drug Assoc
Issue
REF 7
Language
English
Abstract
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.
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