05-22-2015 08:00 AM
We are looking to obtain methodologies to extend a BUD on reconstituted remifentanil 10 mcg/mL to 9 days refrigerated. The PI states that the reconstituted solution is stable for 24 hours. I have a certificate of analysis from a 3rd party testing company that provided us with potency/purity at days 20,33,46,61,96. The preparation met specs at day 20 but appears to have rapidly degraded after that point. Are we able to use that day 20 data point to justify extending our BUD to 9 days refrigerated, or should we obtain methodologies with time points that more accurately reflect practice. IE. Day 1,3,7,9,12.
05-22-2015 08:20 AM
If you want to extend the BUD you need to do sterility testing of each of drug batch you prepare. This is a requirement of USP 797. How much did this potency testing cost you? Did the lab use stability indicating methods in their testing? I have attached an article on this testing. You can test your drug at any time interval you want to use.
05-22-2015 08:43 AM
Thank you for your quick response. We were looking to extend the BUD out to the USP mandated 9 days refrigerated for medium risk preps . Would we still have to sterility test if we extended the BUD from 24h -> 9 days RF even though it falls under the <797> BUDs that do not require sterility testing? The potency testing was quite costly and conducted by DynaLabs. Per the CoA both method suitability and sterility suitability were examined.
05-24-2015 08:40 AM
You don't have to sterility test any of your CSPs if you DON'T exceed the BUDs listed in USP 797. I misunderstood your question. Hope this clarifies the issue.
01-22-2018 10:14 AM
BUD extending methodologies for high risk compounds:
We culture each batch that we compound. How often should we reculture each batch or does that depend upon how far we want to extend the BUD?
Thank you Dana
01-22-2018 11:06 AM
When you say culture, what does that mean? Do you take a 1 mL aliquot of the drug and put into a tube of broth? If yes, this is NOT a compliant method of meeting USP Chapter <71>-Sterility Testing. I have attached an article that details the requirements needed for each and every batch that is assigned extended-dating.