Testing Human Growth Hormone (191AA HGH) samples via both Janoshik and Chromate

I've learned to trust your test reports. I take Chromates with a grain of salt. Hopefully he can establish himself and his methods and prove to us all his testing is reliable.
Well, we're at six months and counting. At this rate I might retire before it is so! :D


Thank you for your trust. If there's any specifics about that test, feel free to ask away.

Cheers
 
Look meaning going by mass spectra of by personal feeling?

Could you show yours, pretty please?
You have provided the mass spec of semaglutide, what does this prove?

Provide the HPLC chromatogram showing separation of the two large impurities, plus mass spectral data for each.

Our original 1100 MSD didn't last long. We are currently finalizing the purchase of a new QTOF system. For now we choose to err on the side caution when a sample is filled with random peaks that aren't supposed to be there.
 
You have provided the mass spec of semaglutide, what does this prove?

Provide the HPLC chromatogram showing separation of the two large impurities, plus mass spectral data for each.

Our original 1100 MSD didn't last long. We are currently finalizing the purchase of a new QTOF system. For now we choose to err on the side caution when a sample is filled with random peaks that aren't supposed to be there.
That the singular peak in my data has clean MS as well, obviously, which is strong evidence of lack of impurities of similar nature, even if there was no chromatographic separation.

I take it that you can't provide support of your data.
 
That the singular peak in my data has clean MS as well, obviously, which is strong evidence of lack of impurities of similar nature, even if there was no chromatographic separation.

I take it that you can't provide support of your data.
The data stands on its own: 2 different vials tested on 2 different columns with the same problematic results --all while no other samples of semaglutide have this issue. Can you provide a plausible explanation for this phenomenon?

sg2-test1.png
sg2-test2.PNG
 
I like that someone who has had no direct competition finally has some and now we have a pissing match because someone else has shown up on the scene… and can directly compete with them…. Oh nooooo… dont take my money im the only one that can do this… more competition breeds better and finer testing…
 
i think janoshik has already proven himself many times to be top tier when it comes to this stuff
He has also conveniently avoided comment on the dimer data.

@janoshik Was the detection of dimer in EP Somatropin CRS (in agreement with 16 international labs) and in @GGC's sample just a lotion-induced aberration or has the unincorporated basement lab outperformed you in this particular analysis?

Was this a one-time mistake or systemic failure in your dimer methodology?

EP Somatropin CRS Batch 4: 0.440% Dimer detected by Chromate

View attachment 286519
View attachment 286521

EP Somatropin CRS Batch 4: Dimer results from 16 international labs (full pdf attached)

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@GGC's Sample #3: 0.331% Dimer detected by Chromate
View attachment 286522
 
Here is the dimer peak clearly detectable in all 3 samples according to the European Pharmacopoeia method for Somatropin:

View attachment 286331

There is a large unknown peak (33% area @ 214nm) which appears after the monomer peak (visible on the chromatogram that we kindly provide as standard on all our reports). We are waiting on mass spec installation for proper verification -- however considering the large size, the ease at which it could be removed via purification, and its periodic presence in samples -- we believe it to be an excipient.

View attachment 286336

Based on the above absorbance plot, if area normalization were performed in the 240 - 250nm range, then the unknown would equate to ~3.5% area and the dimer peak would disappear. Unsure why janoshik does it this way, but other than the dimer and this unknown, there are no other peaks present.
Send me the sample I'll run it on my LC/MS/MS and help you confirm the identitiy of the unknown peak.
 
He has also conveniently avoided comment on the dimer data.

@janoshik Was the detection of dimer in EP Somatropin CRS (in agreement with 16 international labs) and in @GGC's sample just a lotion-induced aberration or has the unincorporated basement lab outperformed you in this particular analysis?

Was this a one-time mistake or systemic failure in your dimer methodology?
That's because I did not feel the need to humiliate you further, but apparently you're leaving me no other choice.

You are a systemic failure, my friend, my dimer measurements are looking the way you can only hope for.
 

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He has also conveniently avoided comment on the dimer data.

@janoshik Was the detection of dimer in EP Somatropin CRS (in agreement with 16 international labs) and in @GGC's sample just a lotion-induced aberration or has the unincorporated basement lab outperformed you in this particular analysis?

Was this a one-time mistake or systemic failure in your dimer methodology?

That's because I did not feel the need to humiliate you further, but apparently you're leaving me no other choice.

You are a systemic failure, my friend, my dimer measurements are looking the way you can only hope for.

You two should get a room because I think something good would come of it.
 
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He has also conveniently avoided comment on the dimer data.

@janoshik Was the detection of dimer in EP Somatropin CRS (in agreement with 16 international labs) and in @GGC's sample just a lotion-induced aberration or has the unincorporated basement lab outperformed you in this particular analysis?

Was this a one-time mistake or systemic failure in your dimer methodology?
didnt a member on here (i think his name is ware) already do a comparison test between jano, you and analizka with primo and you and analizka results came back way off lol
 
What, you don't like it? Looks infinitely better than the dimer you failed to detect @janoshik

So for an idiot such as myself can you and @janoshik explain what we are seeing here? You both tested the same batch of HGH. You claim there is a peak eluting before the main 191aa which is .3% dimer. And the main 191aa is 99.7% purity. Is there no lypholizing preservatives present? Jano is showing 96% purity but no dimer, do we assume the remaining 4% is preservatives and filler and non 191aa molecules that were present in the raw material pre-lyophilizing?
 
So for an idiot such as myself can you and @janoshik explain what we are seeing here? You both tested the same batch of HGH. You claim there is a peak eluting before the main 191aa which is .3% dimer. And the main 191aa is 99.7% purity. Is there no lypholizing preservatives present? Jano is showing 96% purity but no dimer, do we assume the remaining 4% is preservatives and filler and non 191aa molecules that were present in the raw material pre-lyophilizing?
Jano excludes fillers and excipient from the purity results.
When there is some weird excipient that he don’t recognize, he will consider it as impurity but once it’s identified, it won’t be counted.
 

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