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The stability of acetylcysteine eyedrops

The stability of acetylcysteine eyedrops

Australian Journal of Hospital Pharmacy 23(1): 18-21

The stability of acetylcysteine 10% eyedrops in low density polyethylene eyedrop bottles was studied during storage for 90 days at 2-8 degree C, 25 degree C and 37 degree C using a stability-indicating high-performance liquid chromatography (HPLC) assay. Acetylcysteine decomposed to the dimer N,N'-diacetylcystine and no other decomposition product was detected by HPLC. The decomposition of acetylcysteine at 25 degree C and 37 degree C was adequately described by a zero order model, from which the times for the acetylcysteine concentration to fall below 90% of labelled concentration (t-90) were calculated to be 48.3 and 23.6 days respectively. At 2-8 degree C, degradation was not significant over the 90-day storage period. Stability under in-use conditions at 2-8 degree C and 25 degree C for 30 days was also investigated using samples previously stored for 90 days at 2-8 degree C. The rate of decomposition was not significant at 2-8 degree C but at 25 degree C decomposition occurred with t-90 equal to 26.7 days. In-use conditions did not appear to accelerate the rate of decomposition to any significant extent.

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Accession: 009627588

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