Tommy Wall
Member
I ordered by mistake 20ml sterilzed vials instead of 2ml. I use ampoule testoviron enanthate 1ml. I would like to how many ampoules I can fill the 20ml vial with without risking safty.
YearsI ordered by mistake 20ml sterilzed vials instead of 2ml. I use ampoule testoviron enanthate 1ml. I would like to how many ampoules I can fill the 20ml vial with without risking safty.
Years
It stays good way past expiration.[/QUOTE
How far past expiration date is pharmaceutical Test.Cyp.still at stated potency if vial hasn't been punctured?
Does anybody know? Thanks
This is a great question as there is a lot on confusion on how Beyond Use Dates (BUD) are established with compounded products. All compounders are required to use the United States Pharmacopeia (USP) standards when compounding preparations. USP states that for Oil-Based Products a BUD of 6 months or less shall be used if a stability study isn't available for that specific compound. For Water Based Products a BUD of 14 days or less shall be used if a stability study isn't available for that specific compound.
The reason manufacturers can assign 2-3 year Expiration Dates is because they have performed stability studies that take $100,000+ and years to perform. Obviously, compounders cannot afford to do these studies, so when assigning a beyond-use date, compounders consult and apply drug-specific and general stability documentation and literature, and consider the nature of the drug and its degradation mechanism, the container in which it is packaged, the expected storage conditions, and the intended duration of therapy to come to a conservative BUD.
There are many factors to consider in a compounded product including the preservative, base, concentration, excipient, source of active ingredient, vial, stopper, seal, sterilization method, etc. If any of these factors in a compounded product deviates greatly from a manufacturer's then we can't use the same stability results the manufacturer came up with. Since most compounds are made differently from manufactured products we assign very conservative BUDs.
Even though some compounders feel safe to assume stability information on certain compounds, like testosterone cypionate, and have years of data from patients receiving good results from the medication even after the 6 month BUD has past, technically we are still required to put a BUD of 6 months or less unless we have the proper stability study to reference and our product doesn't vary greatly from the manufacture's.
I've personally done 2 year long potency over time studies on our Testosterone Cypionate and it's shown a degradation of less than 7%, but this isn't considered a full blown stability study that the FDA considers valid. Other compounders put what they feel comfortable with at the risk of getting in trouble with the FDA, but that all depends on the compounder.
the may help.
Thanks Vince. I meant to ask about beyond BUD on manufacred Test cyp. Like Watson brand, West-Ward, etc not compounded brands.
Do you have any info about brands?
the may help.
Thanks Vince. I meant to ask about beyond BUD on manufacred Test cyp. Like Watson brand, West-Ward, etc not compounded brands.
Do you have any info about brands?
No I don't but I believe there wouldn't be much of a difference.
You should have said the link was dead. Here is the article
https://www.health.harvard.edu/staying-healthy/drug-expiration-dates-do-they-mean-anything
Hmm, I think I'm being lied to at the pharmacy. I was trying to get a 10ml vial of Test Cyp that would last me over 10 weeks. They told me that they won't sell it to me because once punctured, the vial is only good for 28 days. Sounds like a bunch of crap to me. I will try other pharmacy.
Hmm, I think I'm being lied to at the pharmacy. I was trying to get a 10ml vial of Test Cyp that would last me over 10 weeks. They told me that they won't sell it to me because once punctured, the vial is only good for 28 days. Sounds like a bunch of crap to me. I will try other pharmacy.