suaibatul islamiyah | Stifi Padang (original) (raw)
Pharmacist
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INDIAN AGRICULTURAL RESEARCH INSTITUTE, NEW DELHI, INDIA
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A stability study is a routine procedure which ensures the maintenance of pharmaceutical product ... more A stability study is a routine procedure which ensures the maintenance of pharmaceutical product safety quality and efficacy throughout the shelf life. Stability studies at a developmental stage provides a data base that may be of value in selection adequate formulation to determine shelf life, container closure system and storage conditions for development of new product. In a stability study, the effects of variation in temperature, time, humidity, light intensity and partial vapor pressure on the pharmaceutical product are investigated. These pharmaceutical products are followed by the guidelines issued by International Conference on Harmonization (ICH), World Health Organization (WHO) or other agencies. This review presents the importance of stability testing for any pharmaceutical product. An important point in conducting stability studies are storage conditions which are derived from real climatic conditions. As stability study is tool in cGMP, indirectly to attribute quality product which will increase reputability of company in global market. In this review work we traced the point on recent trends in stability study, recent guidelines, climatic zones, sampling time and plan, estimation of self life, and some stability specifications for pharmaceutical products mentioned.
A stability study is a routine procedure which ensures the maintenance of pharmaceutical product ... more A stability study is a routine procedure which ensures the maintenance of pharmaceutical product safety quality and efficacy throughout the shelf life. Stability studies at a developmental stage provides a data base that may be of value in selection adequate formulation to determine shelf life, container closure system and storage conditions for development of new product. In a stability study, the effects of variation in temperature, time, humidity, light intensity and partial vapor pressure on the pharmaceutical product are investigated. These pharmaceutical products are followed by the guidelines issued by International Conference on Harmonization (ICH), World Health Organization (WHO) or other agencies. This review presents the importance of stability testing for any pharmaceutical product. An important point in conducting stability studies are storage conditions which are derived from real climatic conditions. As stability study is tool in cGMP, indirectly to attribute quality product which will increase reputability of company in global market. In this review work we traced the point on recent trends in stability study, recent guidelines, climatic zones, sampling time and plan, estimation of self life, and some stability specifications for pharmaceutical products mentioned.