4.3 Gonoral Principios ‘The purpose of stability testing is to provide evidence on how the qualty of ‘an active pharmaceutical ingredient or medicinal product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establah a re-est period for the active pharmaceutical ingredient or a shelf Ife for the medicinal product ‘and recommended storage conditions. “The design of the slabilly-lesting programme should take into account the intended market and the climate conditions in the area in which the ‘medicinal products willbe used. Fs tingui Stabity testing, 28 folows s Zone temperate. 2 Zane I: subtropical, with possible high humic. Zonet: nove. 2 Zone WV: hot “The stability testing recommendations inthis guideline cover the long-term storage condition for all Climatic Zones, ie. I= IV. ‘The shot life should be established with cue regard tothe climatic zones) In which the products are to be marketed. For certain preparations, the shelblfe can be guaranteed only i specific storage instructions are ‘complied with. staity vidoe March 206 42.2.7.4 Testing at elevated temperature and/or extremes of humidity Special transportation and climatic conditions outside the storage conditions recommended in this guideline should be supported. by tdditional data. For example, these data con be obtained from studies on one datch of the mecicnal’ product conducted for up 103 months at 50T/ambient humidity to cover extremely hot and dry conditions and at 25CIB0% RH to cover extremely high humidity conditions Stebiity testing at a high humidty condlton, ©.g., 25C/00% RH, is recommended for solid dosage ‘forms in watervapour permeable packaging, e.g., tablets in PVC/aluminium blisters, intended to be Inarkoled in trrtories with extremely high humidity conditions in ZAAINL However, for sold dosage forms in primary containers designed to provide 2 barrer to water vapour, eg. aluminum/aluminium ilsters, stabity testing at a storage condition of extremely high humidity is not considered necoseary. 2.2.7.5 Medicinal products intended for storage in a refrigerator Minimum time period Study Storage conditions covered by data at submission Long tem SOLO 12 months ‘Accelerated | 25°C + 2°C/B0% RH +5% RH 6 months If the medicinal product is packaged in a semi-permeable container. appropriate information should be provided to assess the extent of water loss. Data from refrigerated storage should be assessed according to the evaluation section of this guideline, except whore explicitly noted below. If significant change occurs between 3 and 6 months’ testing at the accelerated storage condition. the proposed shelf life should be based on the real time data available from the long-term storage condition. It significant change occurs within the first 3 months’ testing at the accelerated storage condition, a discussion should be provided to address the effect of shor! torm excursions outside the label storage condition, 0.9 uring shipment and handling. This discussion can be supported, if Stability v4.doe ‘March 2008 18