How long after the "best use date" (BUD) does T cyp/prop retain its full efficacy?
- Thread starter Pacman
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Does anyone have reliable information in this regard with respect to testosterone cream?
Vince
Super Moderator
Easy breezy question about expiration date on T
I noticed the compounded test seems to have much soon expiration date than the big brand pharmacutial meds. i have 2 vials of compounded stuff that says discard after " 9.10.13" and one says 10. 22. 13" curious why the expiration dates are so short and do i really discard this...
www.excelmale.com
That thread is a specific discussion re oil-based injectables and a general discussion about BUDs and water-based vs. oil-based drug deterioration.
My more specific question is whether anyone has reliable information (data-driven and/or based on pharmacological expertise, not just speculation) as to how long a compounded testosterone cream, such as that produced by Empower, can be reasonably expected to retain most of its potency when stored in its original container in a cool, dry place at home.
My more specific question is whether anyone has reliable information (data-driven and/or based on pharmacological expertise, not just speculation) as to how long a compounded testosterone cream, such as that produced by Empower, can be reasonably expected to retain most of its potency when stored in its original container in a cool, dry place at home.
Jason Sypolt
Administrator
The potency of the products do not suddenly drop off a cliff after the BUD, but the loss if any is not known because the products aren't tested beyond when the BUD would be - 6 months, or 12 months, or whatever the BUD is based off of. So the BUD is simply the cutoff date of known values such as potency (and sterility if applicable) based on the testing that was done on the product.
A pharmacy doesn't do the quick and cheap analysis that you are going to find at a peptide site like Blue Sky, and Empower's status as a larger 503B requires even more testing. For an apples to apples testing comparison and analysis that the FDA requires from a pharmacy, you would probably be looking at around $20-30k to get that cream tested.
A pharmacy doesn't do the quick and cheap analysis that you are going to find at a peptide site like Blue Sky, and Empower's status as a larger 503B requires even more testing. For an apples to apples testing comparison and analysis that the FDA requires from a pharmacy, you would probably be looking at around $20-30k to get that cream tested.
I won’t speak to using expiered products, but when I get a new testosterone vial from the pharmacy I’m never sure how long it’s been sitting in the warehouse shelf before I get it.
I shake each new vail for a few minutes as the tiny testosterone particles that are supposed to be suspened in the oil may have dropped to the bottom over time. Shaking for a few minutes can re-suspend them in the oil. Then wait a day to draw out of that vial as the air bubbles will rise back to the top.
That said, never shake HCG. You can slowly swirl it but shaking will damage the HCG particles.
I shake each new vail for a few minutes as the tiny testosterone particles that are supposed to be suspened in the oil may have dropped to the bottom over time. Shaking for a few minutes can re-suspend them in the oil. Then wait a day to draw out of that vial as the air bubbles will rise back to the top.
That said, never shake HCG. You can slowly swirl it but shaking will damage the HCG particles.
Vince
Super Moderator
I also always shake my vial of T, is it necessary, probably not. I'm just ensuring its well-mixed.
Jason Sypolt
Administrator
When it was made will depend on the type of compounding pharmacy you received it from.
A 503B like Empower is an outsourcing facility and can mass produce products. Because of their size, I doubt Their products sit for very long.
A 503A however has to compound the products when they receive a prescription for a specific patient. There is a provision where they can make limited quantities titles in advance for a specific prescribed given an established relationship and anticipatory volume.
So are 503Ais more “fresh”? Probably. But you may have to wait for the product to be made until after they receive the script for you and the level of precision in a 503A can’t even come close to a 503B. A 503A has to hand make capsules because they can’t get a license to use certain machines, so dosage can vary capsule to capsule by as much as 40%. A 503B can use a machine that machine guns out capsules with a variance of less than 1 mcg in weight.
Empower puts a date on their labels of when the batch was created. I believe it’s in the bottom right corner of the label by the discard date.
Testosterone in oil is a solution, not a suspension. Think salt dissolved water. There are not clumps of testosterone molecules floating around the way there are with a water-based testosterone suspension. The exception is that low temperatures can cause testosterone crystals to form. But the remedy is to dissolve the crystals by heating, not shaking. I'm using "testosterone" interchangeably for "testosterone ester" here.
Correct. In a technical sense it's not a suspension.
Per Wiki: "In chemistry, a suspension is a heterogeneous mixture that contains solid particles sufficiently large for sedimentation. ... Colloids and suspensions are different from solution, in which the dissolved substance (solute) does not exist as a solid, and solvent and solute are homogeneously mixed."
madman
Super Moderator
Pure Testosterone comes in a water based aqueous form (suspension) and also in a solvent/oil based form (oily solution).
Regarding oil based esterified T preparations.....the hormone powders (solutes) are dissolved using a solvent such as benzyl benzoate which is than mixed in with the carrier oil whether (sesame, cottonseed, peanut, grapeseed, castor). If the vial is left sitting around for some time the particles will not SEPARATE and would not need to be warmed/shaken unless it was stored improperly at low temperatures which will cause crystals to form in the vial.
Water based suspensions will have tiny particles that are visible to the naked eye. If the vial is left sitting around for some time (flat surface) the particles will eventually SEPARATE/SETTLE (sink to the bottom of the vial) leaving the clear solvents and water on the top and would need to be shaken vigorously before injecting.
* water based suspension- injectable stanozolol preparations such as Winstrol V (veterinary), Winstrol Depot (human) or Testosterone Suspension.
madman
Super Moderator
Regarding crystallization:
Depo®-Testosterone (testosterone cypionate injection, USP) CIII
Pfizer Kalamazoo site has investigated the product complaints on Depo®- Testosterone regarding crystallization of contents in 100 and 200 mg/mL vials. The investigation has found that although crystals have been observed, the formulation of crystals does not impact patient safety, efficacy, or product quality when the US Product Insert (USPI) instructions are followed prior to administration.
Depo-Testosterone 100 mg/mL is a very highly concentrated and 200 mg/mL is a supersaturated sterile solution for injection, comprised of cottonseed oil, testosterone cypionate and benzyl alcohol. The high concentrations of active ingredient makes the product very susceptible to crystallization when exposed to temperatures lower than the ranges recommended on the label [20°C to 25°C (68°F to 77°F)].
Investigation at the Kalamazoo site has concluded that the product meets all registered product specifications when the USPI and product packaging instructions are followed prior to administration.
Potency testing from these lots confirms two key product quality attributes:
-product can be warmed, shaken, and the crystals re-dissolved, when prepared according to instructions found in the product insert and on the vial label; and,
-potency of the retain and complaint samples confirm product potency at the labeled strength.
This product attribute is addressed with specific instructions within the USPI, on the product vial label, and also on product carton.
The USPI states:
“Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Warming and shaking the vial should redissolve any crystals that may have formed during storage at temperatures lower than recommended.”
In addition, the current approved vial label states (see Appendix):
“Warming and shaking the vial should redissolve any crystals that may have formed during storage at temperatures lower than recommended.”
Additional evaluation by Pfizer Global Manufacturing and Quality Operations concluded that there was no impact on efficacy, quality or safety of the product based upon confirmation of strict adherence to internal protocols and procedures.
Based on our testing and a medical and safety evaluation of complaint samples submitted to us, distributed lots of Depo-Testosterone continue to be acceptable for use, even with the presence of crystals, when used as directed in the product insert.
Depo®-Testosterone (testosterone cypionate injection, USP) CIII
Pfizer Kalamazoo site has investigated the product complaints on Depo®- Testosterone regarding crystallization of contents in 100 and 200 mg/mL vials. The investigation has found that although crystals have been observed, the formulation of crystals does not impact patient safety, efficacy, or product quality when the US Product Insert (USPI) instructions are followed prior to administration.
Depo-Testosterone 100 mg/mL is a very highly concentrated and 200 mg/mL is a supersaturated sterile solution for injection, comprised of cottonseed oil, testosterone cypionate and benzyl alcohol. The high concentrations of active ingredient makes the product very susceptible to crystallization when exposed to temperatures lower than the ranges recommended on the label [20°C to 25°C (68°F to 77°F)].
Investigation at the Kalamazoo site has concluded that the product meets all registered product specifications when the USPI and product packaging instructions are followed prior to administration.
Potency testing from these lots confirms two key product quality attributes:
-product can be warmed, shaken, and the crystals re-dissolved, when prepared according to instructions found in the product insert and on the vial label; and,
-potency of the retain and complaint samples confirm product potency at the labeled strength.
This product attribute is addressed with specific instructions within the USPI, on the product vial label, and also on product carton.
The USPI states:
“Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Warming and shaking the vial should redissolve any crystals that may have formed during storage at temperatures lower than recommended.”
In addition, the current approved vial label states (see Appendix):
“Warming and shaking the vial should redissolve any crystals that may have formed during storage at temperatures lower than recommended.”
Additional evaluation by Pfizer Global Manufacturing and Quality Operations concluded that there was no impact on efficacy, quality or safety of the product based upon confirmation of strict adherence to internal protocols and procedures.
Based on our testing and a medical and safety evaluation of complaint samples submitted to us, distributed lots of Depo-Testosterone continue to be acceptable for use, even with the presence of crystals, when used as directed in the product insert.
Gianluca
Well-Known Member
do you think this would apply also for compounded Test? I still have two vials of Test Cyp from Empower that were expired on 10/2023 and wondering if they are loosing any potency
Vince
Super Moderator
I'm 100% sure they're good. I use expired testosterone cyp all the time and my levels are always over the top.
Jake_from_StateFarm
Member
Reviving this thread to ask whether storing Cypionate the the refrigerator may extend it even further beyond expiration date. I currently store in my bedroom (cool/dry/dark). I didn't think oils store well in the refrigerator.
Manufacturers usually recommend against refrigeration as this can result in crystallization. This doesn't cause permanent damage to the product, but if this happens it must be properly warmed to put the testosterone ester back in solution. I suspect that cooling wouldn't provide much additional benefit over what the included benzyl alcohol is doing.
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