Terminal Sterilization of Testosterone

[HereToTeachAndLearn]

Does anyone have any information regarding terminal sterilization of testosterone vials? More specifically, does anyone have information as to possible hormone degradation when using heat for terminal sterilization?

I double filer, .45 and .22, and then dry heat sterilize at 260 F for 120 minutes. I am curious about possible degradation.

I know many/most filter and move on, but is there anyone who follows a similar process to above?

 

[narta]

Not needed unless you want to be extra cautious because you sale to others.

In that case f off and figure it out by yourself.

 

[HereToTeachAndLearn]

Not needed unless you want to be extra cautious because you sale to others.

In that case f off and figure it out by yourself.

You never fail to provide a unique and insightful perspective on things!

 

[HereToTeachAndLearn]

I found an acceptable answer to my question in the documentation for a patent.

Assignee: Bayer-ScheringPharmaAG,Berlin (DE)

METHODS AND PHARMACEUTICAL COMPOSITIONS FOR RELIABLE ACHIEVEMENT OF ACCEPTABLE SERUM TESTOSTERONE LEVELS

“A first step in the preparation of a composition of the invention comprises dissolving the testosterone ester in the co-solvent. Then, the testosterone undecanoate/co-solvent solution is combined with castor oil. The final solution may then be filtrated through a 0,2 μm filter, optionally filled into, for instance, amber-glass bottles, before finally sterilised at 180° C. for 3 hours.“

 

[buck]

I found an acceptable answer to my question in the documentation for a patent.

Assignee: Bayer-ScheringPharmaAG,Berlin (DE)

METHODS AND PHARMACEUTICAL COMPOSITIONS FOR RELIABLE ACHIEVEMENT OF ACCEPTABLE SERUM TESTOSTERONE LEVELS

“A first step in the preparation of a composition of the invention comprises dissolving the testosterone ester in the co-solvent. Then, the testosterone undecanoate/co-solvent solution is combined with castor oil. The final solution may then be filtrated through a 0,2 μm filter, optionally filled into, for instance, amber-glass bottles, before finally sterilised at 180° C. for 3 hours.“

You asked about amount of degradation and i see nothing in that post to answer your question. Perhaps it is little or perhaps they overdose from the start to account for the degradation.

 

[HereToTeachAndLearn]

You asked about amount of degradation and i see nothing in that post to answer your question. Perhaps it is little or perhaps they overdose from the start to account for the degradation.

Actually in the the full document it references 250 mg/ml several times. Bayer Nebido, which is likely the drug being referenced, is dosed at 250 mg/ml, so I do not believe it is a stretch to conclude there is likely to be minimal degradation. This conclusion should at least be as reasonable as, if not more so, than “just filter it.”

I believe personal experiences are of extreme importance, but I believe we can further our knowledge and safety by combining these experiences with documented science.

I am not attempting to convince anyone what they are doing is wrong or substandard, I just want to further my knowledge and increase the safety of what I am injecting into my body.

 

[buck]

I have been brewing over 20 years and have not used heat as a sterilization technique. We all have our comfort zone. If no infections happen and muscle growth occurs then the results were successful from my point of view.

 

[Bigguy81]

Does anyone have any information regarding terminal sterilization of testosterone vials? More specifically, does anyone have information as to possible hormone degradation when using heat for terminal sterilization?

I double filer, .45 and .22, and then dry heat sterilize at 260 F for 120 minutes. I am curious about possible degradation.

I know many/most filter and move on, but is there anyone who follows a similar process to above?

Brother, i haven't read everybody else's comments yet, but I'm pretty sure they'll see the same thing. If you are double filtering using a 22 um at the end there is no need for any more sterilization. Never mind dry heat sterilization. I hope you're not asking because someone you know got an infection or anything?

 

[HereToTeachAndLearn]

When all is said and done, it appears that big pharmaceutical companies both filter and use terminal sterilization. Possibly due to the potential liability, but they do it none the less.

For me, it does not complicate things to have my sealed vials spend two hours in dry heat prior to finishing the brewing process. Is it overkill? A lot of people would likely say yes. It is an additional safety mechanism which requires little to no effort on my part, so it provides me with an added sense of security. Some people will also want that extra sense of security and can now know there is evidence supporting minimal to no degradation due to terminal sterilization by heat.

When every thing is said and done, anything which can be done towards further harm reduction is a win.

Thanks for the input.

 

[Bigguy81]

When all is said and done, it appears that big pharmaceutical companies both filter and use terminal sterilization. Possibly due to the potential liability, but they do it none the less.

For me, it does not complicate things to have my sealed vials spend two hours in dry heat prior to finishing the brewing process. Is it overkill? A lot of people would likely say yes. It is an additional safety mechanism which requires little to no effort on my part, so it provides me with an added sense of security. Some people will also want that extra sense of security and can now know there is evidence supporting minimal to no degradation due to terminal sterilization by heat.

When every thing is said and done, anything which can be done towards further harm reduction is a win.

Thanks for the input.

I agree with you about no degradation in the hormone using heat, but a lot of other members might not, and the reason I do is because of literature. However, and before this I say this I just want you to know I'm not telling you you're wrong, but personally I've never seen any literature that says pharmaceutical companies or compounding pharmacies use any kind of sterilization after is already put into vials. If you have any literature stating this would you mind posting a link or sending it to me in a PM?

 

[narta]

I agree with you about no degradation in the hormone using heat, but a lot of other members might not, and the reason I do is because of literature. However, and before this I say this I just want you to know I'm not telling you you're wrong, but personally I've never seen any literature that says pharmaceutical companies or compounding pharmacies use any kind of sterilization after is already put into vials. If you have any literature stating this would you mind posting a link or sending it to me in a PM?

Terminal heat sterilization is definitely used in pharma settings as gamma irradiation. It's an added step, for ensuring sterilization of the final product due to liability reasons.

 

[Bigguy81]

Terminal heat sterilization is definitely used in pharma settings as gamma irradiation. It's an added step, for ensuring sterilization of the final product due to liability reasons.

I have tons of literature from compounding pharmacies as I'm in the business and i have never seen this. Although I'm talking compounding pharmacies not large pharmaceutical companies. Do you have any literature stating this that you could maybe post a link to or PM me?

Also since you seem to be pretty knowledgeable, can I ask you how you feel about melting points, and degradation? Meaning do you believe the compounds should be taken to the correct melting point and do you believe that by doing that it can cause degradation? I didn't before today, but I actually read some literature today that stated otherwise, so I just wanted to see what you thought?

 

[HereToTeachAndLearn]

I agree with you about no degradation in the hormone using heat, but a lot of other members might not, and the reason I do is because of literature. However, and before this I say this I just want you to know I'm not telling you you're wrong, but personally I've never seen any literature that says pharmaceutical companies or compounding pharmacies use any kind of sterilization after is already put into vials. If you have any literature stating this would you mind posting a link or sending it to me in a PM?

PM sent.

 

[HereToTeachAndLearn]

I have tons of literature from compounding pharmacies as I'm in the business and i have never seen this. Although I'm talking compounding pharmacies not large pharmaceutical companies. Do you have any literature stating this that you could maybe post a link to or PM me?

Also since you seem to be pretty knowledgeable, can I ask you how you feel about melting points, and degradation? Meaning do you believe the compounds should be taken to the correct melting point and do you believe that by doing that it can cause degradation? I didn't before today, but I actually read some literature today that stated otherwise, so I just wanted to see what you thought?

What did you read?

 

[narta]

I have tons of literature from compounding pharmacies as I'm in the business and i have never seen this. Although I'm talking compounding pharmacies not large pharmaceutical companies. Do you have any literature stating this that you could maybe post a link to or PM me?

Also since you seem to be pretty knowledgeable, can I ask you how you feel about melting points, and degradation? Meaning do you believe the compounds should be taken to the correct melting point and do you believe that by doing that it can cause degradation? I didn't before today, but I actually read some literature today that stated otherwise, so I just wanted to see what you thought?

I had some Bayer guides I need to dig to my archive to see if I have them somewhere.

As for mp, it's a usefull tool and I don't really thing any degradation occurs when reaching them. If that was the case, boldenone u, test e, deca etc would degrade at room temperature and he have hplc test if finished products that state the opposite.