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Cosmetics are different, yet similar to pharmaceutical formulations in that they’re susceptible to temperature, humidity, light, and microbial contamination. An unstable cosmetic can no longer fulfill its mission in creating a better appearance. As in [...]
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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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Introduction Part 1 of this blog (Ref. 1) has described at a high level the guidance provided by the European Medicines Agency (EMA) on in-use stability testing of multi-dose products for human use (Ref. [...]
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Introduction ANVISA, the Brazilian human health regulatory authority, has issued in the recent years a number of documents describing in detail what is expected to be presented on Forced Degradation Studies and how they [...]
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In February, Japanese authority MHLW (Ministry of Health, Labour and Welfare) has announced two further changes in pharmaceutical quality regulations. Packaging inserts in the product package will not be mandatory (abolished), but you must [...]
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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!
