Accelerated shelf life modeling of appearance change in drug products using ASAPprime®
| العنوان: | Accelerated shelf life modeling of appearance change in drug products using ASAPprime® |
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| المؤلفون: | Kristina, Flavier, James, McLellan, Teslin, Botoy, Kenneth C, Waterman |
| المصدر: | Pharmaceutical Development and Technology. 27:740-748 |
| بيانات النشر: | Informa UK Limited, 2022. |
| سنة النشر: | 2022 |
| مصطلحات موضوعية: | Drug Stability, Temperature, Pharmaceutical Science, Humidity, Ascorbic Acid, General Medicine, Powders, Indigo Carmine, Tablets |
| الوصف: | An accelerated stability model approach was demonstrated to accurately predict the long-term shelf life of example drug substances and drug products (indigo carmine tablets and L-ascorbic acid powder) where appearance changes were shelf life-limiting. The products were exposed outside of packaging to conditions from 50 to 90 °C and 0-80% relative humidity for up to one month to accelerate appearance changes. The appearance changes of stressed samples were quantitated using the CIELAB color scale (calculated Δ |
| تدمد: | 1097-9867 1083-7450 |
| DOI: | 10.1080/10837450.2022.2112223 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::dfbab947cfb0b2c8ae2aed17ae12d77a https://doi.org/10.1080/10837450.2022.2112223 |
| رقم الانضمام: | edsair.doi.dedup.....dfbab947cfb0b2c8ae2aed17ae12d77a |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 10979867 10837450 |
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| DOI: | 10.1080/10837450.2022.2112223 |