Janoshik Analytical laboratory testing services

We expect results Monday - no kidding.

We had a delay because 1st test kit was bad, so we had to wait for replacement, then we spent 14 days validating the methods instead of anticipated 2-3 days and ran out of supplies.

Then the other kit was supposed to arrive Monday, but arrived yesterday afternoon.

Now today I was in no state to stand and pipette all day (endotoxin testing is heavy dependent on a lot of pipetting) because me and my middle son have pneumonia. And the only other person in the company who can run those tests by herself is on a holiday until tomorrow.

I apologize for the clusterfuck that is.

We can provide you with the results Monday and refund the tests too if you wish.
What were the findings on the validation work? You now have a validated endotoxin recovery method with the oil matrix?
 
What were the findings on the validation work? You now have a validated endotoxin recovery method with the oil matrix?
Good news is yes.

Bad news is we have decided we won't be sharing the details, as it would most likely get stolen by our competitors. I won't be saving them hundreds of manhours of method development.

Unfortunately, other labs are stealing our ideas and IP left and right, thus such decisions come to play.
 
Good news is yes.

Bad news is we have decided we won't be sharing the details, as it would most likely get stolen by our competitors. I won't be saving them hundreds of manhours of method development.

Unfortunately, other labs are stealing our ideas and IP left and right, thus such decisions come to play.
Thanks for sharing. Understood.
 
Good news is yes.

Bad news is we have decided we won't be sharing the details, as it would most likely get stolen by our competitors. I won't be saving them hundreds of manhours of method development.

Unfortunately, other labs are stealing our ideas and IP left and right, thus such decisions come to play.
You shared some anyway just to give me a good tease.

Good man. Now splurge a little and get everyone some of those expensive autopipettors!
 
 
Well, yeah, we tried to run some more samples for the statistics on Friday so we can have a discussion in the lab we used to subcontract on it all and well, basically, the OIL testing for endotoxin is so fucked up, we gave up on trying.

When running the analyses and crossreferencing them with substances in the sample:
Benzyl Alcohol too high? Bam, results fucked up.
No BB? Bam, recovery fucked up.
Too much BB? BAM, processing takes hours which fucks the method up.
Weird kind of oil? Guess what.
Tren? Needs additional blanks.

At this point it looks more like every sinlge concoction would need pretty much new method. Guess that's the reason why it's never ever tested for in the pharmacopoeias.

We will not be touching endotoxin testing in oils again effective immediately.

We are pretty sure our last results were pretty OK, but I can offer a refund for any oil test for endotoxin should anyone desire that. Please, do let me know.

I am not sure what you mean by false safety. We've tested > 250 endotoxin samples in past 20 days alone and while many of them were positive, none ever came close to dangerous levels of endotoxin. I think, with a peace in my heart, I can say that this is much less of a worry than sterility, which can be so-so in the peptides.

I don't think that was a good idea and it had been nothing but a net loss for us. Material costs in the thousands and manhours wasted are countless.
 
Now, I mean, we could charge 800-1000 USD per oil sample to reflect the costs, but I don't think that would be viable for our clients and most importantly, I have been begged by my CSO to just not do it, as it's incredibly frustrating to have to redo the test ten times before we get stable results.

And I prefer my lab techs and CSO not frustrated.
Only thanks to them it's not me doing everything and going crazy / retired.
 
I'd like to clarify - I don't think our AAS oil Endotoxin tests are bad - the issue is that each type of oil basically required us to create a new test for it.

We cannot use routine approach, as we have numbers flying left and right then.

We are a high throughput laboratory and we don't assume people to be willing to be paying 800-1000 USD for a test such as that, so we're dropping it.

On AAS oil Endotoxin testing we've underestimated the influences of the matrix in target recovery and it cost us many thousands of dollars and I've decided to cut the loss here, as we're not willing to run a test at a severe loss (what we've been doing) or send out numbers we're less than confident in.
 
When running the analyses and crossreferencing them with substances in the sample:
Benzyl Alcohol too high? Bam, results fucked up.
No BB? Bam, recovery fucked up.
Too much BB? BAM, processing takes hours which fucks the method up.
Weird kind of oil? Guess what.
Tren? Needs additional blanks.

Would it make sense to have some conditions on the oil to test like :

BA Should be between 0 and 5 %
BB Should be between 10 and 30 %
Oil should be MCT, Sesame, GSO, CSO

I wonder how compounding pharmacies are able to test the endotoxin levels (pretty sure that they must have different preparations)
 
Would it make sense to have some conditions on the oil to test like :

BA Should be between 0 and 5 %
BB Should be between 10 and 30 %
Oil should be MCT, Sesame, GSO, CSO

I wonder how compounding pharmacies are able to test the endotoxin levels (pretty sure that they must have different preparations)
I don't think they test finished oils.

Or do they?

Also the above conditions would mean we have to run multiple tests before testing already.
 
Thanks very much for the updates. Quite a rabbit hole. Thank you for trying.





 
yes, but I scratched what I don't really understand/doesn't make sense
Hi Jano,

So the reported "dimer" value for GH testing includes all DPn greater than DP1 (monomer)? Hence "dimer" on report is DP2, DP3, etc picked up by SEC?

TLDR: "dimer" value on your test reports are all "aggregates (DP2-DPn)" of GH larger than monomer?

Thank you.

For example:

Fig. 5 of attached.

Figure 5 shows
the size-exclusion chromatogram of
somatropin carried out under the same conditions as described previously.
The inset shows the zoomed baseline region where dimer and higher molecular
weight aggregates are evident.
 
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@janoshik
I had a few samples of things tested by your company (thanks!).

The Tadalafil came up at 68% with the rest unknown. I briefly considered trying to purify it myself, but realized this is impracticable because it does not readily dissolve and I am not a chemist to do anything more advanced than basic things.

But this got me curious to better understand how it is analyzed: I know you use methanol but even that is not supposed to dissolve tadalafil. My understanding is that HPLC requires a liquid analyte. How do you get tadalafil dissolved in order to analyze it? I appreciate your helping my understanding.
 
@janoshik
I had a few samples of things tested by your company (thanks!).

The Tadalafil came up at 68% with the rest unknown. I briefly considered trying to purify it myself, but realized this is impracticable because it does not readily dissolve and I am not a chemist to do anything more advanced than basic things.

But this got me curious to better understand how it is analyzed: I know you use methanol but even that is not supposed to dissolve tadalafil. My understanding is that HPLC requires a liquid analyte. How do you get tadalafil dissolved in order to analyze it? I appreciate your helping my understanding.
Tadalafil is nicely soluble in methanol, you just have to use enough of it.

It's not a problem to do something like 1.8 mg/ml and that's plenty for analysing.
 
Hi @janoshik. I've ran into an issue with a generic HGH product (causing excessive night sweats). I've been discussing what the reason for it could be other than a response to my unique physiology (even though a friend of mine running the same GH has the same side effect). Could it be that the HGH is degraded? What would you check for (if a test is available) in degraded HGH that could potentially cause an immune response?
 
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