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STABILITY EVALUATION OF CHLORHEXIDINE PRODUCTS

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					            STABILITY EVALUATION OF CHLORHEXIDINE PRODUCTS

                       Paul Gornbein, Ekaterina Tzirlin, Alexandra Rogov
                                    and Ilana Schumacher


                             I.D.F. Medical Corps, Military P.O.Box 02149, Israel.
                                             schumil@zahav.net.il

The stability of drug products stored in I.D.F. warehouses may deteriorate during their storage
period due to the variations in starage conditions and rough mechanical handling.

Purpose: The objective of this report was to study degradation kinetics of chlorhexidine gluconate
(CG) products, which are used as common antiseptics, when stored under reccommended
conditions over extended period and apply the data for quality and shelf life evaluation.

Methods: 18-21 batches of Chlorhexidine Gluconate containing water or alcoholic solutions (0.5%
w/v in Ethanol 70%, 1.5% w/v, 4%w/v, were tested upon reciept and during their storage at
controlled temprature. Examination included volume, quantitation of active and inactive ingridients
and degradation products, using stability indicating methods.

Results: CG products were found to be stable. Active ingridient content decreased and reached the
lower acceptable level (90%) towards the end of the products shelf life. Alcoholic solution of CG
seems to be more chemically stable than aqueous CG solution. Most of the examined packages
retained their initial volume of filling.

Conclusions: Chemical stability of CG preparations during long term storage under reccomended
conditions was confirmed. Further examination of long term storage stability evaluation of these
products will be continued to ensure stability and quality of the items stored in IDF emergency
warehouses. This examination will include microbiological testing as well as systematic annual
stability evaluation of items stored in various storage conditions.




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