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

[Jerdboben]

Makes sense now.

Welcome back OG! Hope all is well. Good to see you around again.

 

[readalot]

Welcome back OG! Hope all is well. Good to see you around again.

Thank you! I appreciate you taking time. How are you doing?

 

[laclark89]

Makes sense now.

Welcome back lol

 

[AlexDavis43]

Makes sense now.

You missed some pretty big drama.

 

[readalot]

Welcome back lol

Thank you Sir!

 

[readalot]

You missed some pretty big drama.

I caught up on that thread. Good to know. Thanks.

 

[Jerdboben]

Thank you! I appreciate you taking time. How are you doing?

Doing well brother, glad to see you up on it again! Community needs you.

 

[readalot]

Doing well brother, glad to see you up on it again! Community needs you.

Good to hear you are well. Nice to be back. Thanks for taking the time to swing by!

 

[readalot]

Nice overview on endotoxin testing.

https://www.tga.gov.au/sites/default/files/presentation-common-mistakes-and-misconceptions-endotoxin-testing.pdf

 

[readalot]

Bacteria/mold/endotoxins (removed with proper sterile filtration)

My apologies on the error here. Endotoxins aren't removed using sterile filtration. Not sure how I did that but reinforces the need to keep each other honest on these things.

 

[readalot]

The Biologics Revolution and Endotoxin Test Concerns - PMC

The advent of “at will” production of biologics in lieu of harvesting animal proteins (i.e. insulin) or human cadaver proteins (i.e. growth hormone) has revolutionized the treatment of disease. While the fruits of the biotechnology revolution are ...

www.ncbi.nlm.nih.gov

Review article.

Without some basic immunological knowledge, we cannot appreciate the on-going sea-change in which the current “endotoxin as pyrogen-only” model of endotoxin control as being supplanted by control that includes added immune context.

Example process and activated carbon.

Bioprocess and downstream optimization of recombinant human growth hormone in Pichia pastoris - PMC

The methylotrophic yeast Pichia pastoris is a well-established expression host, which is often used in the production of protein pharmaceuticals. This work aimed to evaluate the effect of various concentrations of ascorbic acid in mixed feeding ...

www.ncbi.nlm.nih.gov

Fig. 8

 

[readalot]

Good idea. Picture of production facility is nice and fun and all but the product testing results (many of which we don't ask for at Meso routinely, ok I annoyingly do) tells you the real story.

GA can make the stuff using a staff of extremely well hung trannies only wearing cloth masks in the back room of his "gentlemen's club" as long as the following tests are coming back good...

1.HPLC purity

2.GCMS organic/structural impurities

3.Metals

4. Sterility

5. Endotoxins

6. GCMS residual solvents

What's your specs on these from the routine analytical program you have established @GenericAsia ?

@bjjgear: here you go. Unofficial DRAFT Meso template for your review and consideration.

Draft template for Meso member review. Great idea @bjjgear!

Feedback? Submit to new vendors (and old) as part of vetting process?

 

[readalot]

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)

Thread 'Δ6-testosterone enanthate'

May 28, 2021

A supposedly very PIP inducing raw powder of testosterone enanthate has been received.
Analysis for heptanoic acid yielded negative result, so I decided to dig deeper and a massive contamination of testosterone enanthate with.... testosterone enanthate was found.

However not the usual kind, but delta 6 testosterone enanthate, which is listed, at least in European Pharmacopoeia, as "Impurity F" with maximum permissible limit of 0.3%.

In this case, by very brute approximation, 15.46% of delta 6 testosterone enanthate was found.

• janoshik

• 
• 
• 

Yeah, I'm the f'n clown. Dumbass!

 

[bjjgear]

Draft template for Meso member review. Great idea @bjjgear!

Feedback? Submit to new vendors (and old) as part of vetting process?

Beautiful... any vendor with half a brain and a couple of dollars can get past the "rigor" of Meso denizen requirements, which is frequently (A) a picture of a facility, which in reality doesn't mean shit, and (B) a Jano test of -one batch- of product, which also doesn't mean shit.

If a vendor can't respond relatively quickly, and in an articulate manner, to the template questions above, then that'd be considered a red flag. Caveat emptor, but vendors who display sophistication and enthusiasm about these processes would be considered first tier choices.

 

[readalot]

Beautiful... any vendor with half a brain and a couple of dollars can get past the "rigor" of Meso denizen requirements, which is frequently (A) a picture of a facility, which in reality doesn't mean shit, and (B) a Jano test of -one batch- of product, which also doesn't mean shit.

If a vendor can't respond relatively quickly, and in an articulate manner, to the template questions above, then that'd be considered a red flag. Caveat emptor, but vendors who display sophistication and enthusiasm about these processes would be considered first tier choices.

And Meso denizens can get their pics of the lab staff as well.

Appreciate the review.

 

[bjjgear]

Maybe a couple of sub bullets under HPLC like dimer testing on GH and variance testing on tabs would probably be a good one to cover.

 

[readalot]

Maybe a couple of sub bullets under HPLC like dimer testing on GH and variance testing on tabs would probably be a good one to cover.

Nice point. One above was for AAS injectables. Should have stated. Definitely some mods for GH and other products. Great work!

 

[bigMoJo]

Wow! Glad I found this thread! Will take me another week, I imagine—with all the other sh** I have to get done—to read & comprehend all the linked articles/papers.

I apologize if I'm asking to be spoon fed... TLDR: is the carbon process the method to filter these "endotoxins," if any?

And, let's be honest, there likely ARE such "impurities" in the raw powders, we just don't know what all they may be, the level of significance, who's has how much, and the impact/damage, if any, it may cause... right?

 

[readalot]

Have any of the labs you approached committed or shown concrete signs they will adopt your proposal, or agreed to have the next batch tested?
What are your impressions, at this point? Honestly.

Ironlion: said they would contact Jano on sterility testing

Axle: wouldn't believe anything he says. Watch actions.

Neo: well, you know. Looking to score some promotion points with one off sterility test. Did not sound genuine on really rasing the bar

GenericAsia: said he would address my comments on the testing and that he would share details.

Matrix Labs (SST): agreed to sending in some samples for metals and endotoxins.

Not much progress at this point. Thanks for asking.

 

[readalot]

I apologize if I'm asking to be spoon fed... TLDR: is the carbon process the method to filter these "endotoxins," if any?

Activated carbon is one method. Can share more details on others for biological drugs if you are interested.

And, let's be honest, there likely ARE such "impurities" in the raw powders, we just don't know what all they may be, the level of significance, who's has how much, and the impact/damage, if any, it may cause... right?

I agree. We will have first round of tests back soon.

Thanks for taking a look at all this. I appreciate it.