Non Pharma GLPs not real? GLP Salts? Can someone who knows chemistry explain?

[freddymac]

There have been numerous stories out there about how the GLP pharma companies are starting to go after the compounding pharmacies and weight loss clinics that are offering compounded Semaglutide and Tirzepatide.

One of the things you read over and over is how the non pharma versions are salts or acetate versions of the "real" GLPs. And this someone makes the not real. How this is dangerous, how they may not even work, etc.

While I have a general understanding of esters in how the apply to anabolics, I don't quite get how this applies to peptides.

Can someone dumb this down and explain what exactly a salt version of any GLP is vs the "real" one? Are they really dangerous? Is there any reason to believe the compounded salt version would have any difference in behavior?

 

[ShredSeason]

how they may not even work, etc.

Well, I do know for a fact that this is not true. I am effortlessly fasting and eating at extreme deficits on Reta, the same was the case with Tirz. I’m hoping someone with knowledge in chemistry can tell us about the difference with salts though.

 

[freddymac]

Well, I do know for a fact that this is not true. I am effortlessly fasting and eating at extreme deficits on Reta, the same was the case with Tirz. I’m hoping someone with knowledge in chemistry can tell us about the difference with salts though.

Fair point. We know they work. I’m can attest to that too. Just more of a question as to there being any truth to a difference in efficacy

 

[rirep78]

It's the same shit and just the manufacturers trying to fear monger to the public so they won't buy Chinese grey market stuff and hence lose billions of dollars in revenue. Fuck, their own patent application list their own product in a salt form. A lot of drugs are manufactured in the salt form as it increases solubility in the body. Look at how many meds end in "hydrocholride". That is a salt form.

US10888605B2 - GLP-1 compositions and uses thereof - Google Patents

The present invention relates to pharmaceutical compositions of the GLP-1 peptide semaglutide comprising no more than 0.01% (w/w) phenol, their preparation, kits comprising such compositions as well as uses thereof.

patents.google.com

Semaglutide
The GLP-1 peptide semaglutide may be prepared as described in WO2006/097537, Example 4. Semaglutide is also known as N6.26-{18-[N-(17-carboxyheptadecanoyl)-L-γ-glutamyl]-10-oxo-3,6,12,15-tetraoxa-9,18-diazaoctadecanoyl}-[8-(2-amino-2-propanoic acid),34-L-arginine]human glucagon-like peptide 1(7-37), see WHO Drug Information Vol. 24, No. 1, 2010. In some embodiments semaglutide may be present in the composition in its fully or partly ionised form; for example one or more carboxylic acid groups (—COOH) may be deprotonated into the carboxylate group (—COO−) and/or one or more amino groups (—NH2) may be protonated into the —NH3+ group. In some embodiments semaglutide is added to the composition in the form of a salt.

 

[readalot]

Compounded Semaglutide: Is it worth the risk?

www.mc-rx.com

Decent overview of the legal aspects. The big question are around purity and efficacy. The salts were not used in the clinical trials; there are no therapeutic alternatives to semaglutide base in the FDA orange book. So to your point the compounders are either sourcing from research chemical supplier / China / etc which means they aren't getting the API (active pharmaceutical ingredient) from an FDA approved supplier. You would have to do the pharmacokinetic testing to find the dosing for the salt vs the base and determine bioequivalence.

Long story short the salts could work but you are rolling the dice on purity similar to UGL hGH vs pharma.

More reading...

http://www.ncbop.org/PDF/SemaglutideCompounding.pdf

MSN

Novo Nordisk Sues Florida Compounding Pharmacies Over Semaglutide Impurities

Learn about the emerging lawsuits filed by Ozempic’s manufacturer against two Florida pharmacies compounding semaglutide.

www.drugwatch.com

But no big deal to the experienced lab rats who roll the dice with research chemicals / ugl products unless they have the means to test the products (impurity analysis, API, etc). Look at this product from Empower....

Semaglutide / Cyanocobalamin Injection

Explore our range of commercial and compounded medications, formulated uniquely for individual prescriptions or office use.

www.empowerpharmacy.com

Blatant infringement on patent protection but they get away with it right now since semaglutide on the drug shortage list. Where are they sourcing the semaglutide? Surely Novo is not selling it to them and there are no third party FDA approved manufacturing sources. So make sure you are testing just like with all the other gray / ugl market stuff. Compounders are pretty scummy though to charge top dollar for research chemicals without proper C of A.. That is the whole point of going through compounding pharmacy...the customer believes they are getting a product equivalent to the Pharma product since compounders have to source from FDA approved manufacturer. In this case they aren't.

 

[readalot]

Update: Brooksville gets dismissal based on technicality.

APC: Court publishes dismissal in Novo case against Brooksville

Alliance for Pharmacy Compounding

a4pc.org

Novo Nordisk Inc. v. Brooksville Pharmaceuticals Inc., No. 8:2023cv01503 - Document 33 (M.D. Fla. 2023)

Novo Nordisk Inc. v. Brooksville Pharmaceuticals Inc., No. 8:2023cv01503 - Document 33 (M.D. Fla. 2023) case opinion from the Middle District of Florida US Federal District Court

law.justia.com

 

[AlexDavis43]

Compounded Semaglutide: Is it worth the risk?

www.mc-rx.com

Decent overview of the legal aspects. The big question are around purity and efficacy. The salts were not used in the clinical trials; there are no therapeutic alternatives to semaglutide base in the FDA orange book. So to your point the compounders are either sourcing from research chemical supplier / China / etc which means they aren't getting the API (active pharmaceutical ingredient) from an FDA approved supplier. You would have to do the pharmacokinetic testing to find the dosing for the salt vs the base and determine bioequivalence.

Long story short the salts could work but you are rolling the dice on purity similar to UGL hGH vs pharma.

More reading...

http://www.ncbop.org/PDF/SemaglutideCompounding.pdf

MSN

Novo Nordisk Sues Florida Compounding Pharmacies Over Semaglutide Impurities

Learn about the emerging lawsuits filed by Ozempic’s manufacturer against two Florida pharmacies compounding semaglutide.

www.drugwatch.com

But no big deal to the experienced lab rats who roll the dice with research chemicals / ugl products unless they have the means to test the products (impurity analysis, API, etc). Look at this product from Empower....

Semaglutide / Cyanocobalamin Injection

Explore our range of commercial and compounded medications, formulated uniquely for individual prescriptions or office use.

www.empowerpharmacy.com

Blatant infringement on patent protection but they get away with it right now since semaglutide on the drug shortage list. Where are they sourcing the semaglutide? Surely Novo is not selling it to them and there are no third party FDA approved manufacturing sources. So make sure you are testing just like with all the other gray / ugl market stuff. Compounders are pretty scummy though to charge top dollar for research chemicals without proper C of A.. That is the whole point of going through compounding pharmacy...the customer believes they are getting a product equivalent to the Pharma product since compounders have to source from FDA approved manufacturer. In this case they aren't.

Thanks for taking the time to post all that. I wasn't familiar with the history.

 

[AlexDavis43]

There have been numerous stories out there about how the GLP pharma companies are starting to go after the compounding pharmacies and weight loss clinics that are offering compounded Semaglutide and Tirzepatide.

One of the things you read over and over is how the non pharma versions are salts or acetate versions of the "real" GLPs. And this someone makes the not real. How this is dangerous, how they may not even work, etc.

While I have a general understanding of esters in how the apply to anabolics, I don't quite get how this applies to peptides.

Can someone dumb this down and explain what exactly a salt version of any GLP is vs the "real" one? Are they really dangerous? Is there any reason to believe the compounded salt version would have any difference in behavior?

There is an easy answer. Look at any of the studies on semaglutide. Did you lose that much weight on UGL? (within range/variation)

If not, and testing is showing high purity, then we might have bigger questions to ask.

There are probably many more ingredients in Ozempic than in QSC semaglutide raws, but anecdotal weight loss results are similar.

So in this case other ingredients don't seem to make or break efficacy of semaglutide

 

[trtbuilder]

There is an easy answer. Look at any of the studies on semaglutide. Did you lose that much weight on UGL? (within range/variation)

If not, and testing is showing high purity, then we might have bigger questions to ask.

There are probably many more ingredients in Ozempic than in QSC semaglutide raws, but anecdotal weight loss results are similar.

So in this case other ingredients don't seem to make or break efficacy of semaglutide

Ozempic has:

One mL solution for injection contains 1.34 mg or 2.68 mg semaglutide. Non-medicinal ingredients: disodium phosphate dihydrate, propylene glycol, phenol, and water for injections.

 

[AlexDavis43]

Ozempic has:

One mL solution for injection contains 1.34 mg or 2.68 mg semaglutide. Non-medicinal ingredients: disodium phosphate dihydrate, propylene glycol, phenol, and water for injections.

The additives in Ozempic probably have a reason, but not directly related to weight loss efficacy as we see similar results with QSC sema.

Unless... @Qingdao Sigma Chemicals please inquire about additives in QSC sema and GH. Maybe they're the same.

@freddymac

 

[JDbythesea_]

I am not a chemist (obviously)-
In terms of overseas peptides being salts, anyone experiencing insane water retention on tirz?

 

[trtbuilder]

I am not a chemist (obviously)-
In terms of overseas peptides being salts, anyone experiencing insane water retention on tirz?

No different from name brand mounjaro for me

 

[JDbythesea_]

No different from name brand mounjaro for me

I did sema first for 5 months, did not have this issue, but it’s been fairly significant on tirz from the first week

 

[trtbuilder]

I did sema first for 5 months, did not have this issue, but it’s been fairly significant on tirz from the first week

Could be an initial thing, maybe watch your diet (sodium intake) and make sure youre shitting

 

[TessaM]

I am not a chemist (obviously)-
In terms of overseas peptides being salts, anyone experiencing insane water retention on tirz?

The amount of dietary sodium equivalent would be a 1/430th of a teaspoon or so. Not enough to make any difference.

Water retention is more likely due to the fact that GLP1s causes decreased intake of everything including water--dehydration causes some people's bodies to hang on to it for dear life. Sounds like a paradox but not drinking enough can cause bloating too.

Salts may have a minor effect on solubility or lifespan, but not appreciably.

 

[JDbythesea_]

The amount of dietary sodium equivalent would be a 1/430th of a teaspoon or so. Not enough to make any difference.

Water retention is more likely due to the fact that GLP1s causes decreased intake of everything including water--dehydration causes some people's bodies to hang on to it for dear life. Sounds like a paradox but not drinking enough can cause bloating too.

Salts may have a minor effect on solubility or lifespan, but not appreciably

The amount of dietary sodium equivalent would be a 1/430th of a teaspoon or so. Not enough to make any difference.

Water retention is more likely due to the fact that GLP1s causes decreased intake of everything including water--dehydration causes some people's bodies to hang on to it for dear life. Sounds like a paradox but not drinking enough can cause bloating too.

Salts may have a minor effect on solubility or lifespan, but not appreciably.

Ya, it’s weird, I drink at least 3-4 liters/day, mostly filtered water, but included in that amount is a 32 oz hydroflask of very diluted electrolytes, same as I have been doing for several months. But still the switch to Tirz has made me retain water like crazy. The first week I switched from sema to Tirz scale said I gained 6 lbs. Same calorie intake, same hydration, etc.

Something is different for sure. felt like I needed to get more salt on sema, maybe I need to cut back on it on Tirz?

Thx for your reply.

 

[Bluewarrior]

Ozempic has:

One mL solution for injection contains 1.34 mg or 2.68 mg semaglutide. Non-medicinal ingredients: disodium phosphate dihydrate, propylene glycol, phenol, and water for injections.

disodium phosphate dihydrate – is used as an antioxidant synergist, stabilizer and buffering agent

propylene glycol - is an emulsifier

Phenol – antimicrobial & antioxidant

 

[JDbythesea_]

Ya, it’s weird, I drink at least 3-4 liters/day, mostly filtered water, but included in that amount is a 32 oz hydroflask of very diluted electrolytes, same as I have been doing for several months. But still the switch to Tirz has made me retain water like crazy. The first week I switched from sema to Tirz scale said I gained 6 lbs. Same calorie intake, same hydration, etc.

Something is different for sure. felt like I needed to get more salt on sema, maybe I need to cut back on it on Tirz?

Thx for your reply.

Replying to myself but for anyone it may help -
I quit electrolytes and stuck to H20 for 2 days and dropped 6 lbs water weight overnight. No wonder I felt like garbage. Tirz seems much touchier re sodium for me. YMMV

 

[Pinnacle Elements]

The additives in Ozempic probably have a reason, but not directly related to weight loss efficacy as we see similar results with QSC sema.

Unless... @Qingdao Sigma Chemicals please inquire about additives in QSC sema and GH. Maybe they're the same.

@freddymac

I can almost assure you there is no PG and no water in the lipolyzed puck of sema