Understanding risks involved with suboptimal purity of gray peptides

[sepehr]

Good folks of the forum,

Been reading this article recently:

Understanding Peptide Purity & Dosage Variance in Tablets | Notion

Peptide Purity Explained

factorygirl202.notion.site

Look at this test for QSC Tesamorelin 10mg which came out at purity of 97.480%:

Janoshik Analytical

I understand we take ambigous risks taking gray peptides. However, I would like to have your help understanding more specific details about these risks caused by the impurities injected into one's body; especially in case of such low purity peptides.

 

[GimmeABreak]

I understand we take ambigous risks taking gray peptides. However, I would like to have your help understanding more specific details about these risks caused by the impurities injected into one's body; especially in case of such low purity peptides.

I am NOT an expert but have spent time reading about this.

You don't know the effects the degraded peptides will have on your body, are they just broken amino chains. what have the degraded peptides turned into?

There is a good chance you will experience more side affects taking a degraded pep.

Dosing can also be an issue, can you assume 10mg at 97% is 9.7mg when you calculate your dose? Probably not.

Why has the peptide degraded and will it continue rapidly degrading over a short period of time? Certainly possible.

Testing is just a point-in-time where we take a look at the pep, what will the purity be in a month, two months, no way to tell without testing again. At this point you are beyond the cost of the cost of the degraded peps.

 

[Cndmk]

Personally? I have a family member who works in big pharma (think like senior management/director scientist, and was a scientist themself earlier) who I talked with my journey on grey peptides and tried to align my acceptance criteria to industry acceptance standards on normal peptide formulations.

I have worked in many technical/engineering roles throughout the years, so testing methodology is everything to me.

Long story short, my family member said "Anything under 98.5% you would be surprised at some of the side effects/unexpected materials we have seen, and we try to aim for 99% if possible", so when I asked "would you take peptides at 99.XX% and have a 10% testing rate?", that person said "yes I would be fairly confident that at least your sampling is sufficient to be representative of the batch."

So that's what I aim for, 98.5%+ (why settle for less than 99% purity though?) and 10% testing methodology, randomly chosen by myself. In reality, this is a lot higher than 503 pharmacy standards, but I feel as if it's warranted because we deal with additional variables and liability with our health that pharmacies don't deal with (they deal with it through money, not their health)

I've stopped caring about sterility as I just filter everything.

 

[YoYoFat]

Personally? I have a family member who works in big pharma (think like senior management/director scientist, and was a scientist themself earlier) who I talked with my journey on grey peptides and tried to align my acceptance criteria to industry acceptance standards on normal peptide formulations.

I have worked in many technical/engineering roles throughout the years, so testing methodology is everything to me.

Long story short, my family member said "Anything under 98.5% you would be surprised at some of the side effects/unexpected materials we have seen, and we try to aim for 99% if possible", so when I asked "would you take peptides at 99.XX% and have a 10% testing rate?", that person said "yes I would be fairly confident that at least your sampling is sufficient to be representative of the batch."

So that's what I aim for, 98.5%+ (why settle for less than 99% purity though?) and 10% testing methodology, randomly chosen by myself. In reality, this is a lot higher than 503 pharmacy standards, but I feel as if it's warranted because we deal with additional variables and liability with our health that pharmacies don't deal with (they deal with it through money, not their health)

I've stopped caring about sterility as I just filter everything.

Doesn't EL say that as low is 80% (maybe even 70%) is acceptable for use in their T patent?

I mean, that's actually BigPharma's documented acceptance rate.

 

[penewbie]

Doesn't EL say that as low is 80% (maybe even 70%) is acceptable for use in their T patent?

I mean, that's actually BigPharma's documented acceptance rate.

Yes they did.

 

[AndyPanda]

I tried to find something on here and couldn’t. Has Jano ever tested Ozempic or Mounjaro to get a baseline? I think people assume that the brand stuff is completely pure. After all the drama with COVID vaccines, I lost a lot of trust in big pharmacy companies.

 

[hansie]

if youre thinking of buying their tesa, i wouldnt. they linked a different batches' COA and the one that was sent out was the green tops that tested at 95.0%, even lower. me and a user on reddit go this batch and both had some gnarly side effects. we threw out the whole kit after less than a week of pinning, not worth it.

 

[raw_oyster_eater]

i'm wondering if tesa degrades quickly. i have a reconstituted vial that gelled up really ugly. shot another 1ml bac into it to un-jell it but it still looks cloudy with chunks.

 

[YoYoFat]

I tried to find something on here and couldn’t. Has Jano ever tested Ozempic or Mounjaro to get a baseline? I think people assume that the brand stuff is completely pure. After all the drama with COVID vaccines, I lost a lot of trust in big pharmacy companies.

A baseline for what, exactly?

Date of manufacture? A year later, when the expiration date is still good but it’s likely degraded?

 

[AndyPanda]

A baseline for what, exactly?

Date of manufacture? A year later, when the expiration date is still good but it’s likely degraded?

I guess just overall purity and percentage of peptide. To see if it is actually any better than what us fools are consuming.

 

[Cndmk]

Doesn't EL say that as low is 80% (maybe even 70%) is acceptable for use in their T patent?

I mean, that's actually BigPharma's documented acceptance rate.

Acceptance rate sure, but what a process aims for vs. what it achieves from a desired result are very different, like a customer spec vs a product spec:

Customer specs are USUALLY a bit tighter than product specs, mainly because the use case is better known (not sure if this is the same for pharma production)

When I was early in my career in a company where we made microchips for some car components, just because a lot would barely pass the product spec, an engineer might scrap a large portion of the lot because “I don’t want that chip in my car” and lot variability can cause failures you might not necessarily see, statistics are a Bi1ch sometimes, and weird things happen at molecular scale to electrical pathways.

Also, I’m sure during early phase production and testing of these GLP-1’s, you will probably find some interesting “disaster” lots in production, where engineering can run limits testing on the product, that’s probably where the “acceptance of viability for 70-80%” come from, that probably means they tested for “does the product seem to have the same effect” and less testing of “what else is happening”

I would guess many other industries with stupid margins operate the same way.

 

[Cndmk]

sorry I’m adding on to this again, if a product still has an acceptance rate of 70-80% that could be over the lifetime of the product, which may factor in slow degradation over the expected lifetime of viability.

So what that could also mean in this situation, if the final product starts at like 98%, but the product lifetime in cold storage is 2 years, maybe the product hits that 70-80% over those 2 years.

I’ll have to read the patent itself to see if it is worded as “at time of production” or “in the products lifetime”

Electronics don’t operate like peptides in degradation (obviously), so my knowledge of how the means and limits testing is derived and written out could be very different.

 

[scarywood75]

I'm too lazy to re-write it, so here's a a repost of explaining HPLC tests;

Purity ≠ concentration. This is a very important distinction.

Purity measures the concentration of a given compound vs anything that is similar structurally and chemically to it.

In fact, the actual compound only accounts for 10% of the total mass in the vials. It's mixed with mostly excipients to help for fill accuracy and preservation.

So a HPLC purity test is good for identifying the presence of one or more of the following :
- Impurities; starting materials, intermediates and by-products.
- Degraded products; breakdown, oxidized or hydrolyzed products.
- Isomers; any compound similar to the given target

We can't tell from a normal HPLC test where the impurity is coming from; could be something benign like oxydation or something more dangerous like non-reacted products.

We also don't know the composition of everything else in the vial.

In brief; purity does not tell the whole story, it's preferable to have something higher because anything that is not like the reference is not good to have, but a 96% purity with 4% from oxydation is better than 98% purity with 2% of non-reacted products. We also don't know about everything else in the vial that accounts for 90% of the total mass.