On published stability data actually covers the community has more anecdote than the confidence in this thread implies, and I include my own contribution in that.
Asking directly, because I could not find a straight answer: What published stability data actually covers, and what it does not
A question about published stability data actually covers that I think has a definite answer, unlike most of what I ask here.
I have the reasoning below and I am fairly confident about the direction. I am not confident about the size, and the size is what the decision turns on.
Published stability data applies specifically to the formulation studied, under the specific conditions stated. It does not automatically transfer to something reconstituted at home in a different concentration with a different diluent. That caveat is not small.
Post #2 answers the question as asked. The question underneath it is different.
Visible particulate is a strong signal in the other direction: it is a reason to stop and ask rather than to filter and proceed.
I have separated what I observed from what I concluded, which does not always happen.
What I want from this published stability data actually covers thread is the list of things that would need to be true for the claim to hold. If we can write that list, we can check it.
I read post #4 twice before replying, because I had assumed the opposite.
Clarity is a weak test. A solution can lose a significant fraction of its active content to degradation or adsorption while remaining perfectly clear.
A qualification I should have led with rather than closed on.
Adding a note of thanks rather than an opinion. I did not know most of that.
Room-temperature stability claims for licensed products in this class are specific about duration and about whether the period is cumulative. Cumulative is the word that gets dropped in summaries.
Bookmarking this. I will come back when I have something worth adding.
On published stability data actually covers the community has more anecdote than the confidence in this thread implies, and I include my own contribution in that.
On post #8 — agreed on the reasoning, with one qualification.
I changed my mind about published stability data actually covers after someone here asked me for the source and I could not produce one. That is worth saying out loud because it is the ordinary way it happens.
Published stability data covers a specific formulation at a specific concentration in a specific container. A home-reconstituted preparation matches none of those, and that caveat is the whole of the honest answer.
Speaking for myself and not for anyone else who has posted here.
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