Shelf life of T? (efficacy, potency, safety)

[Pacman]

I tried researching this all over the internet, but unfortunately all I got was bro science answers on steroid forums (which differed greatly from forum to forum).

What is the shelf life of T? At the moment, I'm asking primarily about Testosterone Cypionate, but while I'm at it, I'd be interested in knowing the same info for Propionate, transdermals, etc...

One vial of T-Cyp has the message "Discard after [one year after date filled]" and the other vial I have (from a different pharmacy) has a BUD of like 4 months after the date was filled. Why is this?

Is there some kind of consensus on the actual efficacy, potency, and safety of using T-Cyp after these dates? And why do these dates differ so greatly from one another? Aren't all T-Cyps created equal? And what about the other forms of T?

 

[fmalianos]

this is something I too would like to know. But I actually get paranoid that every time I inject air into the vial I am degrading the testcyp

 

[Pacman]

this is something I too would like to know. But I actually get paranoid that every time I inject air into the vial I am degrading the testcyp

That's a good point. I actually was asking from the aspect of a vial not even being opened (just sitting there in the dark closet away from light and heat), but I also wonder by how much oxygen exposure shortens its shelf life....

 

[Vince]

The only thing that could happen is it could lose potency but would it be enough to notice? I doubt it. As long as it's at room temp and out of sun light it's good.

 

[CoastWatcher]

The expiration date is keyed to when the vial was filled. The vial you rec'd from the pharmacy expiring in four months was manufactured, but not sold, some time ago. It gets into our hands at some point down the supply chain. I'm sure Jasen can speak to this in detail.

 

[Jasen Bruce]

Great questions Pacman
I know I have posted some info before on BUD but could not locate it.
The BUD has everything to do with recent enforcement (and updates) in USP797 which governs all sterile injectables. In the recent past, a compounding pharmacy could rely on previous established BUD as long as the formula was identical to the previously established formula. Now, 10% of every batch must be sent to a third party (govt approved) testing facility prior to being dispensed. BUD is established once the testing facility sits on the medication for 30, 60, 90, days etc and at those intervals if sterility and potency still pass, than they can allow a BUD up to that date. The reason for the variance in BUDs between pharmacies is because as these regulations recently updated, pharmacies are catching up on testing product to establish BUD. 4 months means that is the length of time that batch of cypionate has been confirmed to remain potent and sterile. Some pharmacies may have longer BUDs while others shorter, depending on how long the lab tested them. It costs the pharmacy not only to test each batch, but also in the time and product lost while waiting for the test results allowing them to move forward. Some more uncommon injectables may only have a BUD of 3 days on it, this just means the pharmacy has not yet paid or it to be tested therefore the default is 3 day dating. Its annoying especially when you know the injectable is good for much longer and it has been used for years safely. On the flip side its also for our safety because there was bad pharmacies cutting corners and not properly testing injectables to save money, or increase turn around time. Now you know you will consistently get a potent and sterile medication from any pharmacy in the US.

 

[Jasen Bruce]

Just saw your question on transdermals
If a transdermal cream (Lipoderm, HRT, etc) when it starts to turn yellow you want to discard.
Gels will become "chunky" or discolored.
It does not take long for this to happen when gels/creams are exposed to air. If properly stored you should get 3 months out of them (usually topicals are used up in this time frame)

 

[Pacman]

Thank you for explaining the whole concept of BUD. That does quite adequately explain as to the major variance in date ranges from different pharmacies. That certainly does take away a large chunk of confusion. But two points that I'd be particularly interested in knowing are:

1) Is there a way to somehow calculate when the date of manufacturing was, based on the BUD? Or possibly calculate a certain date range of manufacture based upon the three scenarios of testing that you mentioned (30, 60, 90 days)? (I didn't quite get how they determine four months of use based off of 1,2, or 3 months of testing. Do they transpose those results to project a future expiration date or something?)

2) Is there a way to calculate the actual date or approximate period of time when the substance starts to lose potency? Maybe based on the date of manufacture (if we could do that)?

I'm asking these questions primarily because it seems to me that the FDA has a tendency to err on the side of caution, and they probably include variables such as exposure to sunlight/oxygen that decreases their already decreased official "FDA guidelines" BUDs... So, if a vial is kept in a cool, dark place, unopened; what would be the actual amount of time that it starts to lose potency?