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- Posts: 26
- Joined: Mon Aug 04, 2008 2:24 pm
Could anybody provide me with some guidance on developing an experiment for acid/base degradation of a transdermal product? Thank you.
Well, at some point you probably developed a stability specification for this product. Say that spec is about 80% of nominal. You would then want to devise an experiment that degrades the active to about 80% of nominal.
Generally, when I do this I extract the product in question and subject it to about 2 N HCl or NaOH for 16 hours at 70 or 80 C. Run the samples and see what they look like. If you completely killed your product, then ease up a little bit. If nothing happened, then not much is likely to happen and you can almost safely state that reasonable [acid,base] degradation has no effect upon the product/active.
