Source QC and C of A (do you have one?)

[readalot]

I like ur ideas they do go hand and hand with harm reduction. ur a smart dude, I'm starting to think u have some type of stake in a heavy metal testing operation lol.

This is 2023 we are surrounded by heavy metals, in our food air water u name it. View attachment 274144View attachment 274146
it's in our water and kids baby food? Untill gear is legalized it's not gana happen. Like I read above 90% of us ugl users dont care.

For the 10percent if they are worried that much can go once or twice a year and check there levels.

My dad was poisoned or had high metal levels multiple times. He grew up being poisoned with chromium 6 "part of the Erin brockovich thing" later went to work for dow chemical "lead production" and had to be reassigned other duties multiple times because his levels were too high (they tested often) . I dont think any of that caused him real permanent damage, call em lucky. At 70 he got lung cancer after 50 years of smoking cigarettes.

Thanks for your comments. I have tried to make as clear as I can but perhaps I need to do better. Heavy metals/metal contamination is not the primary concern with all this although it should be routinely checked as part of panel identified above. And I agree with you that other consumer products as the ones your highlighted above and even simple tuna cans most likely pose a higher relative risk.

My comments above...see bold.

I disagree that it is impractical and unrealistic to test for heavy metals and perform non targeted impurity analysis plus basic endotoxin screen for each finished batch. My hypothesis is that it is realistic and practical. I want to make it part of the cost of doing business. Will the customer agree as they become educated with new data?

Initially the impurity work is going to take some iteration as I don't think we have ever seen HR-LCMS applied to the latter analysis for UGL. GCMS yes. But as Jano has stated GCMS is limited by impurity boiling point.

The piece of all this that is most sorely lagging is the ID/quantification of the typical 1-5% impurity pile in AAS raws. The majority is most likely not metals / heavy metals but unreacted raw materials for the chemical synthesis, side products, or spent catalyst that was not removed during purification (typically crystallization for AAS). Also any residual solvent?

[These comments above begin to address your questions @Jickzer . The impurity profile will be unique to the AAS product being synthesized.]

In your experience when a substance tests at 98-99%, what is the other 1-2% typically?
Please give some examples of different types of materials and also how the impurities most likely got there.

So as part of this identification (initial) and quantification (later stage) we will be able to gauge what risk these impurities pose to the user or whether they are more innocuous than the AAS API. For example it may be that for many raws the major impurity is the androstane starting material or unreached carboxylic acid for the ester. The key is to determine and ensure raw manufacturers are doing their job on the synthesis and purification. What impurity level is too much? There is a standard that seems to be acceptable now. With the ID of those impurities will that standard still be acceptable?

@Millard makes a great point that most injectables are loaded with BA / BB (baceteriostatic agents) so seemingly little risk of endotoxin activity. Hence unless there are particulates floating around then another relatively small risk from bacterial contamination / infection (but again trust but verify).

Hope this helps explain some of this @laclark89 . I have no financial interest in any of this for the record. Just a member of the AAS using community who is attempting to raise the bar for education and harm reduction with UGL products. My self interest as I disclosed previously is that I may end up using these products at some point so I am doing my due diligence now. Everyone will win though with the information that gets daylighted.

I am very sorry about your Dad. Take care.

 

[laclark89]

Thanks for your comments. I have tried to make as clear as I can but perhaps I need to do better. Heavy metals/metal contamination is not the primary concern with all this although it should be routinely checked as part of panel identified above. And I agree with you that other consumer products as the ones your highlighted above and even simple tuna cans most likely pose a higher relative risk.

My comments above...see bold.




The piece of all this that is most sorely lagging is the ID/quantification of the typical 1-5% impurity pile in AAS raws. The majority is most likely not metals / heavy metals but unreacted raw materials for the chemical synthesis, side products, or spent catalyst that was not removed during purification (typically crystallization for AAS). Also any residual solvent?

[These comments above begin to address your questions @Jickzer . The impurity profile will be unique to the AAS product being synthesized.]




So as part of this identification (initial) and quantification (later stage) we will be able to gauge what risk these impurities pose to the user or whether they are more innocuous than the AAS API. For example it may be that for many raws the major impurity is the androstane starting material or unreached carboxylic acid for the ester. The key is is to determine and ensure raw manufacturers are doing their job on the synthesis and purification.

@Millard makes a great point that most injectables are loaded with BA / BB (baceteriostatic agents) so seemingly little risk of endotoxin activity. Hence unless there a particulates floating around then another relatively small risk from bacterial contamination (but again trust but verify).

Hope this helps explain some of this @laclark89 . I have no financial interest in any of this for the record. Just a concerned member of the AAS using community who is attempting to raise the bar for education and harm reduction with UGL products. My self interest as I disclosed previously is that I may end up using these products at some point so I am doing my due diligence now. Everyone will win though with the information that gets daylighted.

I am very sorry about your Dad. Take care.

No I'm with u. I'd pay a few extra dollars a bottle for that piece of mind its nice saving money but u cant put a price on ur health or sanity. I just dont care to push for it, ur gana have to start a union lol.

 

[readalot]

https://www.agilent.com/cs/library/primers/Public/5991-1876EN.pdf

https://www.sciencedirect.com/science/article/abs/pii/S0731708510006503?via%3Dihub

Not a unique issue with ugl products as we saw with many of the blood pressure drug recalls in the last few years.

Curious if any of the analytical testing options available to AAS enthusiasts today would pick up hydrazine.

 

[clearheaded]

I don't know specifically about AAS synth, but yes heavy metal catalysts are often involved in many synth. various grades of catalysts etc will of course give final product more or less of these.

Id be far more concerned about the heavy metal levels in GHK-cu though.. particularly as majority of GHK-cu raws are meant for cosmetic/topical use and possibly just lyophilized after purchase such "cosmetic" grade.. although yes stilll test high purity.

I know jano has said he tested some for heavy metals but at what sensitivity and enough to be confident 90% are all "free" of heavy metals? I mean MOST things have heavy metals so if saying picked up NONE obv isn't super sensitive. or perhaps he determined levels are well below acceptable level

I think what is probably more concerning is residual solvents aswell as what those solvents dissolve ie plastic. if ultra pure AAS typically is a crystalline and odourless and your getting oily or smelly raws, chances are some solvents in there. some are better than others, but some "safe" solvents can carry some nasties along with them.

 

[readalot]

I don't know specifically about AAS synth, but yes heavy metal catalysts are often involved in many synth. various grades of catalysts etc will of course give final product more or less of these.

Id be far more concerned about the heavy metal levels in GHK-cu though.. particularly as majority of GHK-cu raws are meant for cosmetic/topical use and possibly just lyophilized after purchase such "cosmetic" grade.. although yes stilll test high purity.

I know jano has said he tested some for heavy metals but at what sensitivity and enough to be confident 90% are all "free" of heavy metals? I mean MOST things have heavy metals so if saying picked up NONE obv isn't super sensitive. or perhaps he determined levels are well below acceptable level

I think what is probably more concerning is residual solvents aswell as what those solvents dissolve ie plastic. if ultra pure AAS typically is a crystalline and odourless and your getting oily or smelly raws, chances are some solvents in there. some are better than others, but some "safe" solvents can carry some nasties along with them.

Great points. Thanks for your comments.

let's take a 96% purity stanozolol raw. Big difference if majority of impurity is unreacted methyltestosterone or mestanolone vs range of solvents employed in synthesis and purification. You won't know the presence of any of these impurities in finished product via HPLC quantification of API concentration.

 

[readalot]

Update:

So far I've reached out to @Axle Labs and @Qingdao Sigma Chemicals about impurity testing on their products. Commendable job by axle to agree to some type of impurity testing. No word from @Qingdao Sigma Chemicals yet. Looking forward to hearing more about proposal from axle on testing scope. Perhaps picking two bread and butter raws employed in finished products may be a good start.

====

DRAFT

** How about a typical test cypionate raw (what's the typical purity this is testing at?) E.g. 95 to 98% with mean 97%.

And

** A 17-aa aas raw (oxandrolone or stanozolol)? What is range on purities you are getting on these? E.g. 95 to 98% with mean 97%.

Could add in a few positive controls with pharma or compounded pharma products although the absolute concentration of impurities will be lower than in the raws obviously.

My recommendation would be to select representative raw samples users would be exposed to via finished products. Would also need to blind raws sent to the lab. But I understand currently not much of this testing is going on so first few rounds may be susceptible to manipulation.

Scope

1. ICP
2. Gcms/lcms qualitative non targeted screen

Will need to discuss with analytical lab the details and cost. I am open to partially fund (CIM) this initial scouting work if these tests are cost prohibitive @Axle Labs.

====


If CIM doesn't work I am aware of a service to convert CIM to BTC with surcharge.

Others?

Would welcome others thoughts and suggestions.

I will reach out to other subscribers here as time and interest permits. Suggestions on other subscribers to involve?

 

[readalot]

Could add in a few positive controls with pharma or compounded pharma products although the absolute concentration of impurities will be lower than in the raws obviously.

Ok, I am going to start with the simplest example I could think of that may be of interest to members. Getting a C of A from Pharma isn't as easy as it used to be. This took a little work with persistence. I have sanitized some of the details from this one to protect manufacturer confidential information as per forum Terms and Rules.

This is an FDA approved Testosterone Cypionate product manufactured in a large FDA inspected site in Europe operating under USP standards. The manufacturer provides TC to multiple wholesalers who then sell to pharmacies. Will be a decent baseline for comparison.

I confirmed my vial was authentic with manufacturer and here is the C of A for the lot my vial came from.

Ingredients on label:



Certificate of analysis:




I'll add comments on the testing performed and some of the USP requirements.

You can see on p.2 that the testosterone cypionate effectively tested at 99.91% purity (0.09% organic impurities). There is an "unknown" impurity testing at 0.087%. Interesting to see the known impurities they test for. Not sure where they classify any residual cypionic acid.

You'll also notice testing for sub-visible particles, decomp products of BB, heavy metals, solvents and elemental impurities.

To @Millard 's point I am unreasonable. Any R&D Analytical Group worth their salt would quickly determine what this "unknown" impurity pile is via LC/GCMS + NMR. But the finished product spec of NLT than 99.2% purity on the Test Cyp is met so perhaps they know just don't list.

 

[Pinnacle Elements]

Some thoughts/suggestions for discussion after looking around here.

Realistic, overkill, get what you pay for, don't care?

Would like to hear members' thoughts, counterpoints, etc. especially on cost vs quality. The path to quality is known. Will people pay or too much for UGL customers?

=======

Every Source should provide with each shipment ...

1. 3rd party C of A on finished product batch specific to that shipment
- endotoxin screen
- metals with ICP
- purity(ies) / concentration(s) using hplc plus ms (or gcms)

2. C of A for bulk api for each batch (hplc plus ms or gcms) upon request.

Of course Sources would do themselves a big favor if they screened for impurities as well as purity on the APIs (aka raws) upfront so no surprises on the finished batches. First things first.

There should never be any surprises with a batch. Completely addressable.

And please clean up the product listings...

1. mg is not a unit for API concentration. Use mg/ml.

If I see 200 mg listed and later on a mention that it is a 10 ml vial I am going to assume your stuff is drastically underdosed. That should be clear to you to.

Best practice is listing the API concentration plus the total API per total vial volume.

Example: 300 mg/ml (3000 mg per 10 ml)

2. Denote volumes (ml) for finished vials. People don't want to guess.


3. List the oil used for injectables and also the excipients/preservatives used plus their concentrations.

What is this deal with not disclosing what is in the vial? You don't know, or is it a trade secret lol? Come on.

4. Spend at least as much time assuring your customer you know basic chemistry as you spend on the beautiful packaging design and gimmicks/marketing.

Be the change.

======

Is this a template Meso should endorse for Sources? Even daylighting the concepts with a suggested template would go a long way to educate consumer and further harm reduction initiative IMO.

instead of calling upon existing sources- Why don’t you just become a source and do all this?

 

[readalot]

instead of calling upon existing sources- Why don’t you just become a source and do all this?

I have a day job, and the long term prospects for a source in certain parts of the world are slightly worse than being a crash test dummy.

Thanks for asking though.

 

[readalot]

Readalot, your hubris astonishing. You need to actually read more and learn more and stop making up your own science. I will not reply to you again.

My bad @Scruf ....forgot to copy you. See post 87 above for some of the latest science I made up.

 

[readalot]

Ok, I am going to start with the simplest example I could think of that may be of interest to members. Getting a C of A from Pharma isn't as easy as it used to be. This took a little work with persistence. I have sanitized some of the details from this one to protect manufacturer confidential information as per forum Terms and Rules.

This is an FDA approved Testosterone Cypionate product manufactured in a large FDA inspected site in Europe operating under USP standards. The manufacturer provides TC to multiple wholesalers who then sell to pharmacies. Will be a decent baseline for comparison.

I confirmed my vial was authentic with manufacturer and here is the C of A for the lot my vial came from.

Ingredients on label:

View attachment 274482

Certificate of analysis:
View attachment 274483
View attachment 274484
View attachment 274485

I'll add comments on the testing performed and some of the USP requirements.

You can see on p.2 that the testosterone cypionate effectively tested at 99.91% purity (0.09% organic impurities). There is an "unknown" impurity testing at 0.087%. Interesting to see the known impurities they test for. Not sure where they classify any residual cypionic acid.

You'll also notice testing for sub-visible particles, decomp products of BB, heavy metals, solvents and elemental impurities.

To @Millard 's point I am unreasonable. Any R&D Analytical Group worth their salt would quickly determine what this "unknown" impurity pile is via LC/GCMS + NMR. But the finished product spec of NLT than 99.2% purity on the Test Cyp is met so perhaps they know just don't list.

Question for you @janoshik since this type of analysis may greatly increase routine testing scope for your business ...see post 87 above.

In the context of document attached (stability vs non-stability indicating methods) and C of A in post 87, would your HPLC-DAD setup be able to resolve the API from the other organic impurities (side products, degradation products) listed? I would imagine you'd have to so some exploratory work for each AAS product to ensure HPLC properly resolving organic impurities from API?

Residual solvents (class 2 and 3 from USP) should be easy with GCMS/LCMS.

Let me know if you need CAS numbers. Notice the HPLC method places the bulk of impurity measured (post 87) into an "unknown pile" (lazy). I seriously doubt it is unknown.

Thanks for your time in advance.

https://www.usp.org/sites/default/files/usp/document/FAQs/strength-stability-testing-compounded-preparations.pdf

Seems like these questions also get into how you assess raw purity and the result you share. You must have some confidence your HPLC method is a stability indicating method for each raw you analyze (no co-elution, peak overlap, etc). How do you define purity in the raw AAS test you offer?

 

[Pinnacle Elements]

I have a day job, and the long term prospects for a source in certain parts of the world are slightly worse than being a crash test dummy.

Thanks for asking though.

So how about either put up or shut the fuck up?

 

[readalot]

So how about either put up or shut the fuck up?

I am putting up plenty if you care to take the time to read. Putting up time (my valuable time) and offered money (my money). Are you offering to contribute as well?

And I don't even use these products haha.

@Axle Labs offered to participate. QSC was a polite no lol. I am trying to work on the details (yeah details no one cares about, blah blah, I know, you guys just want your drugs, blah blah) with @janoshik (appears the only viable option at the moment) even though it won't be blinded for him since not too many people running these tests I imagine.

would you like to contribute @Pinnacle Elements ? Put up or STFU.

 

[Pinnacle Elements]

I am putting up plenty if you care to take the time to read. Putting up time (my valuable time) and offered money (my money). Are you offering to contribute as well?

And I don't even use these products haha.

@Axle Labs offered to participate. I am working on the details with @janoshik (appears the only viable option at the moment) even though it won't be blinded for him since not too many people running these tests I imagine.

would you like to contribute @Pinnacle Elements ? Put up or STFU.

I test everything I get.

Does your day job not pay you enough to do the same for yourself? Lawl

 

[readalot]

test everything I get.

Test for what? Please do tell.

Have you been following along? Lost the plot?

Your logic is first rate. Wow.

 

[AlexDavis43]

@Axle Labs offered to participate.

I bet they regret this now.

 

[readalot]

I bet they regret this now.

Why would that be?

 

[trtbuilder]

I am putting up plenty if you care to take the time to read. Putting up time (my valuable time) and offered money (my money). Are you offering to contribute as well?

And I don't even use these products haha.

@Axle Labs offered to participate. QSC was a polite no lol. I am trying to work on the details (yeah details no one cares about, blah blah, I know, you guys just want your drugs, blah blah) with @janoshik (appears the only viable option at the moment) even though it won't be blinded for him since not too many people running these tests I imagine.

would you like to contribute @Pinnacle Elements ? Put up or STFU.

Your time is only valuable to you. Nobody else cares.

 

[readalot]

Nobody else cares

Nobody?

 

[lift4lyfe]

I am putting up plenty if you care to take the time to read. Putting up time (my valuable time) and offered money (my money). Are you offering to contribute as well?

And I don't even use these products haha.

@Axle Labs offered to participate. QSC was a polite no lol. I am trying to work on the details (yeah details no one cares about, blah blah, I know, you guys just want your drugs, blah blah) with @janoshik (appears the only viable option at the moment) even though it won't be blinded for him since not too many people running these tests I imagine.

would you like to contribute @Pinnacle Elements ? Put up or STFU.

Appreciate the effort, readalot, and I put in an order with Axle only because of his willingness to participate. I’ll only be supporting vendors willing to participate in readalot’s efforts in furthering harm reduction and education, and I’m guessing there’s a silent group of us here that will do the same.