introduction. 21ºC ± 2ºC. Zone I was defined to Temperate, Zone II Subtropical or Mediterranean, Zone III hot and dry, and Zone IV hot and humid. Temperature. real-time (long-term) stability studies Experiments on the physical, chemical, biological, biopharmaceutical and ... corresponding to climatic zone IV. It varies up and down from the set temperature. Design of stability studies 71 4. It is normally higher than the arithmetic mean temperature. 12 Months. 65% rH ± 5% rH. The stability studies is one of the very important parameters of pharmaceutical products. 60% rH ± 5% rH. The principle has been established that stability information generated in any one of the three regions of the EC, Japan and Refrigerated. it also outlines the storage condition for the drug substance. stability studies give the shelf life of the drug or the product. • Additional advice given, e.g. Labeling and Incubation of Stability Study Samples : Affix the colored label (Annexure-5) on each of the show boxes. The temperature and long term testing conditions for the four zones are mentioned below. 45% rH ± 5% rH. 30ºC ± 2ºC. Zone I. 12 Months. climatic zones • Zone I temperate • Zone II subtropical, with possible high humidity ... from stability studies (always specifying a temperature limit!) Zone III. 30ºC ± 2ºC. For the purpose of stability testing ICH recommended the world climate into four zones, namely, I,II,III ad IV. Stability studies on active substances and packaged dosage forms are conducted by means of “real-time,” long-term tests at specific temperatures and relative humidities representing storage conditions experienced in the distribution chain of the climatic zone(s) of the country or region of the world concerned. Climatic Zone. conducting stABilitY studies - recent chAnges to cliMAtic Zone iv life science i technicAl Bulletin issue n°13 / MArch 2009 Stability testing is a routine procedure performed on drug substances and drug products to provide evidence on how the quality of a drug varies with time under the influence of a variety of parameters. This guideline addresses climatic zones I and II. hence it is crucial to know the storage conditions. States. 30ºC ± 2ºC. Criteria used to classify a site according to climatic zone Criteria Guidevalues for individual climatic zone I II III IV Mean annual temperature measured in the open air Calculated mean annual Temperature (< 19°C) Mean annual water Vapour partial pressure up to 15°C up to 20.5°C up to 11 mbar > 15 – 22°C > 20.5 – 24°C > 11 – 18 mbar The temperature and humidity controller shall be calibrated as per schedule. 25ºC ± 2ºC. Minimum Duration. Description. Humidity. 75% rH ± 5% rH. Zone II. given the different climatic conditions in the world, climatic zones … Suppose we set a stability chamber at 30°C but it shall be 29.4, 29.8 or 30.6 many times in the specified period of time and we found the degradation of the drug by 0.6% in that period. 12 Months. Stability assessment and shelf-life prediction is usually a major focus of … Incubate the samples as per the required storage conditions mentioned in the intimation slip for the stability study. 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