Description. Humidity. 60% rH ± 5% rH. Temperature. 12 Months. Minimum Duration. For the purpose of stability testing ICH recommended the world climate into four zones, namely, I,II,III ad IV. • Additional advice given, e.g. The zone IV was subsequently split into zone IVa and IVb. Climatic Zone. The stability studies should be conducted on the drug substance packaged in a container closure system that is the same as or simulates the packaging proposed for … 30ºC ± 2ºC. 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. Zone I. Design of stability studies 71 4. model ... study, tentative shelf-life, stability-indicating methods) 23 21ºC ± 2ºC. Zone IV. real-time (long-term) stability studies Experiments on the physical, chemical, biological, biopharmaceutical and ... corresponding to climatic zone IV. The temperature and long term testing conditions for the four zones are mentioned below. 45% rH ± 5% rH. Incubate the samples as per the required storage conditions mentioned in the intimation slip for the stability study. 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. The mean kinetic temperature in any part of the world can be derived from climatic data, and the world can be divided into four climatic zones, I-IV. 25ºC ± 2ºC. 12 Months. Stability assessment and shelf-life prediction is usually a major focus of … States. The principle has been established that stability information generated in any one of the three regions of the EC, Japan and 12 Months. 65% rH ± 5% rH. introduction. 35% rH ± 5% rH. climatic zones • Zone I temperate • Zone II subtropical, with possible high humidity ... from stability studies (always specifying a temperature limit!) stability studies give the shelf life of the drug or the product. Zone I was defined to Temperate, Zone II Subtropical or Mediterranean, Zone III hot and dry, and Zone IV hot and humid. 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 12 Months. it also outlines the storage condition for the drug substance. Zone III. The temperature and humidity controller shall be calibrated as per schedule. It is normally higher than the arithmetic mean temperature. Refrigerated. Zone IVb. Zone II. The stability studies is one of the very important parameters of pharmaceutical products. Labeling and Incubation of Stability Study Samples : Affix the colored label (Annexure-5) on each of the show boxes. This guideline addresses climatic zones I and II. 30ºC ± 2ºC. It varies up and down from the set temperature. 30ºC ± 2ºC. 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. hence it is crucial to know the storage conditions. 12 Months. given the different climatic conditions in the world, climatic zones … 75% rH ± 5% rH. 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