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In the tightly regulated world of pharmaceutical, medical device, and biologics manufacturing, contract storage facilities – warehouses or off-site stability storage facilities - play a vital role in ensuring product integrity over time. Whether [...]
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Stabilitarians and Stakeholders ask over and over; “What are effective measurements to evaluate a Stability Function?"; “How long should the various processes take?”; “How can you repair or eliminate problems of deviations, time over-runs, & [...]
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This blog post is Part 1 of the series and comes to us from Piero De Filippis, StabilityHub EU Regional Contributor, Verona (Italy). Part 1: Stability Study Design for an Investigational Medicinal Product European [...]
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Dear Santa, I have been a good Stabilitarian this year. I had all chamber calibrations conducted on schedule and didn’t lose any samples. I didn’t miss any responses to chamber alarms and all tests [...]
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So, your Stability Program is underway and/or flourishing. You’re focused on protocols, samples, chambers, disaster planning, testing, data analysis and reports—Each one gobbling up resources. You may happily have those resources in place, but [...]
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The presence of traces of N-Nitrosamine impurities in pharmaceutical products was first noted around 2018 in some sartans, particularly sartans that contained a tetrazole ring in their chemical structure and specifically Valsartan. It soon became [...]
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In the pharmaceutical, food, and chemical industries, product stability is paramount. Ensuring that a product maintains its quality, potency, and safety over its intended shelf life is critical for both consumer safety and business [...]
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Stability studies are critical for ensuring the safety and efficacy of pharmaceutical products over time. However, managing the risks associated with these studies presents a considerable challenge. These risks can stem from numerous factors, including [...]
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May was Stability Information Month, and the information sources did not disappoint. This month’s (June 2024) Newsletter carries the hot topics that emerged from StabilityHub’s Office Hours, the PSDG Meeting at KENX’s Laboratory University [...]
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A stabilitarian encounters new situations every day. StabilityHub’s discussion forums give Stabilitarians an opportunity to ask questions and offer solutions to specific scenarios. Join in the conversations with other Stabilitiarians and share your knowledge!
