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

[AlexDavis43]

Easy to ask for things to be done when it isn't out of your own pocket.

This. To my knowledge, he still hasn't sent anything for the proposed testing.
Like, not even 1 vial.

 

[AlexDavis43]

The elephant in the room remains: where's the evidence of harm from these impurities (eg, the 2% in something that tested at 98%)?

We've been using gear for decades.

 

[Spaceman Spiff]

The elephant in the room remains: where's the evidence of harm from these impurities (eg, the 2% in something that tested at 98%)?

We've been using gear for decades.

Particles that get filtered out. Let's say there are some heavy metals too. What percentage of that would be heavy metals and how dangerous would it be.
1-2 gram of gear a week. 2% is heavy metals... assuming you get good quality oils/solvents.

 

[DECLAN]

Maybe we should look at it differently and use @readalot ’s gusto to everyone’s advantage. Let him keep annoying the sources to test the impurities then nobody needs to shell out cash.

All we have to do is hold out on buying any product till they do, maybe, say 6 months; surely, the impact would be huge if Meso members only buy from sources who do the additional tests right.

Let mr. readalot bug do his thing and in the meantime we keep pretending the other things in our drugs are fairy dust to help us get swole.

Then hopefully it will end well, harm reduction while no expense on our part.

 

[readalot]

PDEs:

Permitted Daily Exposure Calculation

Pharma Calculation is a popular educational site for pharmacy students, pharmacy technicians and pharmaceutical professionals.

www.pharmacalculation.com

https://journals.sagepub.com/doi/full/10.1177/1091581820946746

https://www.pharmout.net/wp-content/uploads/2018/02/D2.T1.3.1-Update-on-Toxicology-and-Permitted-Daily-Exposure-Requirements_Jacob-MacDonald.pdf

Elemental impurities:

https://www.usp.org/sites/default/files/usp/document/our-work/chemical-medicines/key-issues/232-40-35-1s.pdf

USP 232 and 233 Pharmaceutical Elemental Impurity Testing

www.intertek.com

https://eag.com/wp-content/uploads/2017/09/M-27317-Elemental-Impurities.pdf

Residual solvents:

https://www.sciencedirect.com/science/article/abs/pii/S0731708520316824

https://ptfarm.pl/pub/File/Acta_Poloniae/2010/1/013.pdf

Raw Materials and Excipient Testing

Eurofins BioPharma Product Testing has a wide range of chemistry expertise and state-of-the-art instruments required to perform raw materials testing.

www.eurofins.com

Eurofins BioPharma Product Testing Services

Eurofins BioPharma Product Testing provides comprehensive laboratory services to support all functional areas of bio/pharmaceutical production.

www.eurofins.com

Impurities Testing for Pharmaceutical Products and APIs

Eurofins BioPharma Product Testing offers a wide range of services to support impurities testing from residual solvents to E&L and degradant-related impurities.

www.eurofins.com

https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/revisions/gc-467-residual-solvents-ira-20190927.pdf

https://www.fda.gov/media/71738/download

https://www.fda.gov/media/71737/download

View: https://youtu.be/9kxmXaK9uks

@BST-rawspharma
@Turkish Pharmacy
@Steroidify Rep
@hutechlabusa
@Driada Medical
@Axle Labs
@MuscleCandy
@Stanfordpharma1
@Qingdao Sigma Chemicals
@GoodLyfe
@AASraw.com
@AlexDavis43
@Spaceman Spiff
@homebrewers
@everyone

Example calculations anyone?

 

[AlexDavis43]

Particles that get filtered out. Let's say there are some heavy metals too. What percentage of that would be heavy metals and how dangerous would it be.
1-2 gram of gear a week. 2% is heavy metals... assuming you get good quality oils/solvents.

So what we talking about here, in terms of end points:

Alzheimer's, cancer, or heart disease much sooner or just a little bit sooner?
On top of the gear use.

 

[Cereal masturbator]

Anyone remember that guy Martin Shkreli that brought the rights for the AIDS medication and then jacked up the price by like 5000% and now he’s like universally hated

You’re the Martin Shkreli of this forum, every post I see you comment on someone’s calling you a cunt and it makes me laugh so much

 

[readalot]

I like this figure. Shows the behavior as one staid practice is glacially, then explosively replaced by another:

You can replace the ordinate axis name with "acceptance".

 

[nightprowler7]

How did you make it through grade school without being stuffed in a locker

 

[readalot]

How did you make it through grade school without being stuffed in a locker

Too big for that. We would have been buddies LOL. Only way people can get away with that stuff is online. Easy to be/talk tough on the internet.

Funny you mention, seems like some members are still stuck mentally in grade school / Jr. High. There's always hope.

 

[Dkland]

Ok @readalot i have an actual question. You may have addressed this previously and may not have. I haven’t read every post here in your thread. I mean hell…….1/3 of them are just calling you a cunt anyway.
I understand the reasoning of testing the raws vs just the finished oils. My question is this……
Impurities or contaminants or heavy metals that may be found in raws…….what if any methodologies or processes are available to ugls to remove them? Or even reduce them to “safe” levels?
The kind of testing you propose would identify and (I hope) quantify the impurities. But is there a real actionable process to remove them?
Or is the only solution “go find better raws”?

 

[Obscured78]

A face of the movement emerges...

Smart but not a smartass? Check

Gets it? Check

Uses UGL products? Check

Great communicator? Check

Seeks to understand? Check

Cool username? Check

Simply excellent how you framed that @lift4lyfe . Well done and thank you.

Can't wait to hear the answers to those questions you posed. Cuts straight to the matter.

Crazy thing is I was recently thinking this was your alt account

 

[readalot]

Ok @readalot i have an actual question. You may have addressed this previously and may not have. I haven’t read every post here in your thread. I mean hell…….1/3 of them are just calling you a cunt anyway.
I understand the reasoning of testing the raws vs just the finished oils. My question is this……
Impurities or contaminants or heavy metals that may be found in raws…….what if any methodologies or processes are available to ugls to remove them? Or even reduce them to “safe” levels?
The kind of testing you propose would identify and (I hope) quantify the impurities. But is there a real actionable process to remove them?
Or is the only solution “go find better raws”?

Thank you for an excellent question. Really important concept.

The 3 tests I included above in the testing package would identify 3 groups of impurities.

1. GCMS + HPLC would identify organic compounds that aren't the active ingredient in the raw. For example, in oxandrolone synthesis one side product could be CAS Common Chemistry. These androstane variants may have much less anabolic activity than the active ingredient but I'd lump them into the not more harmful than the active ingredient pile.

2. The second impurity pile of interest are residual solvents used in the synthesis or purification steps for the raw. I've listed these in detail above (class 1, 2, 3). Residual solvent testing would audit the raws manufacturer to make sure they aren't cutting corners on the crystallization/purification step of manufacture leaving solvent in the raw that should not be there.

3. The third pile is elemental impurities (the most harmful are referred to as heavy metals). These could stem from leftover catalyst that isn't properly removed during crystallation or inappropriate material of construction for the synthesis / purification steps (corrosion or leaching from the process vessel).

So as you can see the data collected would be actionable in that piles 2 and 3 could be cleaned up using proper choice of solvents, proper crystallization and solvent removal and proper choice of materials of construction. Pile 1 is a function of conversion/selectivity of the synthesis steps.

Now whether the manufacturer would want to clean up their act if they got caught is another thing. Right now there is no process check being done. My hope is that if issues are found the consumer would have the data to pressure the manufacturers and market forces could do their job if the community truly values harm reduction.

I am skeptical the raws quality found on the ugl wholesale market rivals USP raw material. Don't trust and verify.

If 4.99% of the 5% impurity pile turns out to be pile 1 then the consumer has reasonable piece of mind. If it is class 1 or class 2 RS or class 1 metals then that data is actionable as well. I don't know why the manufacturer would clean up their act without the proper audit.

Too bad you could not read the important posts in this thread with all the litter.

Thanks again. I was hoping for these types of questions much earlier in the thread.

 

[readalot]

amount of detected compound compared to the standard / weighted amount of the sample

Of course, proper separation with orthogonal confirmation is a must.

It should be noticed the usual way the Chinese QA/QC places, or MZ Biolabs take is to calculate purity from peak area %, which is called area normalization and it is suitable only in very specific scenarios and in general is not a proper way to do it. It's cheap, fast and allows those places to be good results pill mill, but the proper way is to calculate purity from
amount of detected compound compared to the standard / weighted amount of the sample.

Thank you again for taking the time to write that out. Well done!

Will be an important point as we examine the HPLC reports shared by raw AAS manufacturers.

In your experience what is the typical bias range (purity by area count minus purity by mass ratio)? 1.5 to 3% lower by latter accurate method?

Parity Plot

What do you think about a figure showing this information? You could plot purity by mass ratio on the x axis and purity by area count on the y axis with all the data you have. Then include a line with slope of 1.

Would be an instructive tool to allow customers to understand the risk involved in trusting area count purity metrics.

Principles of Chromatography Method Development

This chapter aims to explain the key parameters of analytical method development using the chromatography techniques which are used for the identification, separation, purification, and quantitative estimation of complex mixtures of organic compounds. Mainly, the versatile techniques of...

www.intechopen.com

Fun reading:

https://pubs.acs.org/doi/10.1021/jm500734a

 

[janoshik]

In your experience what is the typical bias range (purity by area count minus purity by mass ratio)? 1.5 to 3% lower by latter accurate method?

Oh no no, nothing like that. It can easily range up to 95%. Normalisation used incorrectly can yield 100% pure result with something that has an API content of 5% and the rest is flour.

 

[readalot]

Oh no no, nothing like that. It can easily range up to 95%. Normalisation used incorrectly can yield 100% pure result with something that has an API content of 5% and the rest is flour.

Thank you. I trust people reading this feel reassured haha. I was just seeing some 100% results in some of the threads which is a big red flag and should immediately disqualify the integrity/quality of the supplier.

My failure was to drastically overestimate the integrity of some vendors.

 

[janoshik]

Would be an instructive tool to allow customers to understand the risk involved in trusting area count purity metrics.

I just tell people if their testosterone was 95% table salt, area normalisation would show it at 100% pure anyway.

Easier to imagine, less work for me.

 

[readalot]

I just tell people if their testosterone was 95% table salt, area normalisation would show it at 100% pure anyway.

Easier to imagine, less work for me.

Although perhaps unclear to many, I really appreciate you reinforcing the point that sample prep/extraction plus lack of RRFs can be leveraged to obtain extremely misleading purity results. Thank you.

 

[readalot]

Someone forgot to tell product development team there is no budget for quality control and testing...

That's expensive considering a source here sells 100 tablets of 50mg anavar for only $34

#FYourTesting_JustGimmeCheapStuff

HRINO...Harm Reduction In Name Only

A source here openly states he tests his raws by sniffing them. F me.

 

[AlexDavis43]

So what we talking about here, in terms of end points:

Alzheimer's, cancer, or heart disease much sooner or just a little bit sooner?
On top of the gear use.

What are the theoretical risks?