TABLE II

Storage Conditions Descriptiona

IDTime Point DescriptionConditionsSimulated Time (mo)
T0Freshly filled0
RT55 mo25 °C ± 2 °C; 40% HR5
RT1212 mo25 °C ± 2 °C; 40% HR12
RT2424 mo25 °C ± 2 °C; 40% HR24
AT125 weeks60 °C ± 2 °C; 40% HR12
AT2410 weeks60 °C ± 2 °C; 40% HR24
AT3615 weeks60 °C ± 2 °C; 40% HR36
ACAutoclave stress treatmentCycle: 60 min at 121 °C24
  • a RT, real-time; AT, accelerated time; AC, autoclave cycle.