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Each pharmaceutical, biological, medical device, vaccine, and cell therapy company employs or contracts scientists who subject the product to a range of temperature, humidity, and light over a period of time, test the product periodically [...]
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Perennial conference presentations about regulatory citations (483’s & Warning Letters in the US) often show Stability Function citations in the Top 10 list. A contributing factor to keeping Stability a permanent resident in the Regulatory [...]
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Many of today’s pharmaceutical formulations, to some degree, are sensitive to oxidation. Besides a loss of efficacy and reduction in shelf life, exposure to oxygen can result in product discoloration, toxicity, or other pharmacological [...]
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With a high percentage of API’s sensitive to moisture, the moisture-barrier characteristic of a pharmaceutical packaging is gaining greater prominence. Within this article, LOG presents insights about WVTR testing and its specially designed moisture-barrier [...]
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The Pharmaceutical Stability Discussion Group (PSDG) is a not-for-profit professional affinity association that exchanges information on-line and through regular meetings to update its participants on activities, regulations and practices related to all aspects of [...]
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February 19 has been proposed as a national day to recognize the process, as well as the scientists who conduct the experiments to determine the stability of medical products, which results in the prescribed [...]
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A recent PSDG poll revealed only 8% of participants anticipated relaxed travel bans this year and two-thirds preferred not to travel even when permitted. When you think about it, except for some real-life shipping [...]
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Stabilitarians may be well-served by the Navy motto: "Don’t give up the ship!" We are used to being the anchor of the medical product supply chain by assuring the stability of outgoing products. We [...]
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What makes us seek a job with the word "Stability" in it? As an entry level liquids and semi-solids formulator, I was taking cancer-causing dyes out of cough syrup formulations, turning campho-phenique liquid into [...]
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Storyteller-Strategist Len Wilson points out that Socrates, who never wrote, said that the invention of writing would produce forgetfulness and only a semblance of wisdom, but not truth or real judgment. His student Plato, [...]
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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!
