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

[GGC]

For our newest Batch of HGH (Batch GGC17) we decided to pull 2 vials from 5 different kits and send 1 of each to both Janoshik and Chromate to crosscheck results. Please see below.

Batch GGC17 per Janoshik:
Average 11.09 per vial, ~110iu kit
Average 96.59% purity
Zero Dimer
Top Colour: Black
Janoshik Analytical

Batch GGC17 per Chromate Anaytical:
Average 11.18iu per vial, ~110iu kit
Average 99.69% purity
Average 0.312% dimer (or other oligomers and related proteins)

Chromate | Analytical Services​

 

[GGC]

Tagging both @janoshik and @Chromate to welcome their inputs on procedure, results commentary, et cetera.

Of note to me, Janoshik results are consistent with what we expect - highly sensitive to purity since the 2021(?) changes in methodology/sensitivity, averaging 96.5% purity per vial while Chromate interprets a higher purity ~99.7% result across the board.

Janoshik also notes no dimer whereas Chromate notes a small amount, but includes a disclaimer that the dimer reading encapsulates all(?) other impurities.

Interestingly the results from Chromate seem to be more A+B, in that the Purity reading appears to simply be 100% minus the perceived dimer content.

Both services delivered results within 2 business days of samples being received, no complaints from me on service.

 

[Fattyone]

Irrespective of accuracy, your growth (at least the 6 you sent lol) are crazy consistent which is cool to see.

 

[nightprowler7]

I have seen enough blind samples with Janoshik to trust his result more. I've also sent two of the same samples months apart and got the same result from Janoshik. To me thats proof of consistency with how he runs his lab. This is just my personal opinion.

 

[Fullchamber]

Tagging both @janoshik and @Chromate to welcome their inputs on procedure, results commentary, et cetera.

Of note to me, Janoshik results are consistent with what we expect - highly sensitive to purity since the 2021(?) changes in methodology/sensitivity, averaging 96.5% purity per vial while Chromate interprets a higher purity ~99.7% result across the board.

Janoshik also notes no dimer whereas Chromate notes a small amount, but includes a disclaimer that the dimer reading encapsulates all(?) other impurities.

Interestingly the results from Chromate seem to be more A+B, in that the Purity reading appears to simply be 100% minus the perceived dimer content.

Both services delivered results within 2 business days of samples being received, no complaints from me on service.

Thank you for getting your samples tested from two different labs. This initiative will only add more to your current and potential customers. Once I am done with my current kit, I’ll be ordering again.
And yes, two different results which makes it quite interesting. I am not sure how they are testing your samples would be curious to have their input on it.

 

[Fullchamber]

For our newest Batch of HGH (Batch GGC17) we decided to pull 2 vials from 5 different kits and send 1 of each to both Janoshik and Chromate to crosscheck results. Please see below.

Batch GGC17 per Janoshik:
Average 11.09 per vial, ~110iu kit
Average 96.59% purity
Zero Dimer
Top Colour: Black
Janoshik Analytical

Batch GGC17 per Chromate Anaytical:
Average 11.18iu per vial, ~110iu kit
Average 99.69% purity
Average 0.312% dimer (or other oligomers and related proteins)

Chromate | Analytical Services​

@Spaceman Spiff i hope this helps.

 

[Spaceman Spiff]

@Spaceman Spiff i hope this helps.

Sorry. Helps what? Kind of caught me off guard

 

[Chromate]

Here is the dimer peak clearly detectable in all 3 samples according to the European Pharmacopoeia method for Somatropin:



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.



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.

 

[Chromate]

Oh here is janoshik's data:



Not sure what is going on here. Clearly there is no sensitivity in dimer detection (can it even be detected via RP-HPLC?). As for those impurities, maybe it is the hGH fragmenting in real-time from having to endure such a wonky method.

At Chromate we only use validated methods: EUROPEAN PHARMACOPOEIA 6.0

 

[bighunanballs]

Oh here is janoshik's data:

View attachment 286342

Not sure what is going on here. Clearly there is no sensitivity in dimer detection (can it even be detected via RP-HPLC?). As for those impurities, maybe it is the hGH fragmenting in real-time from having to endure such a wonky method.

At Chromate we only use validated methods: EUROPEAN PHARMACOPOEIA 6.0

It is interesting that @janoshik didn't pick up the dimer. I've heard a lot of sources like using chromate coa's since they're usually abnormally high?

 

[janoshik]

It's interesting that dimer and purity always add up to 100% too, isn't it?!

Nobody else finding that interesting?

Wonky.

 

[Chromate]

It's interesting that dimer and purity always add up to 100% too, isn't it?!

Nobody else finding that interesting?

Wonky.

I can assure you it is not all that interesting considering dimer and monomer were the only relevant peaks detected.

In contrast here is a different sample ran on the same day:



Monomer: 90.068%
Dimer: 3.685%
Related proteins: 1.050%

In this case the dimer and monomer add up to 93.753% (but, why does it even matter?)

What is actually interesting is that your dimer test is unable to detect the 0.3% dimer which is present and easily detected using the EP validated method.

Janoshik results are consistent with what we expect - highly sensitive to purity since the 2021(?) changes in methodology/sensitivity, averaging 96.5% purity per vial

You have become accustomed to expecting ~96.5% purity -- are manufacturers incapable of purifying the peptide beyond this point? Most perplexing; the Janoshik Special Method sounds wonderful!

 

[xeonmasters]

FIGHT MOFOS! FIGHT!

Now GGC must create a HGH with 110% of purity with -0.1% dimer (Yes, a HGH that oxides to HGH!)

 

[GGC]

You have become accustomed to expecting ~96.5% purity -- are manufacturers incapable of purifying the peptide beyond this point? Most perplexing; the Janoshik Special Method sounds wonderful!

If there is any clarification required, what I mean is that the 96.5% purity figure is consistent with what we expect results from Janoshik to look like from this batch, as we can compare it to previous batches from the same manufacturer that he has also tested. I am glad to have gotten this first test completed with Chromate as well so that we can better interpret future results if there is any deviation.

I defer to you gentlemen to educate me on why one methodology might see 99%+ purity versus 96.5%, or zero dimer versus a >0 quantity.

 

[janoshik]

You have become accustomed to expecting ~96.5% purity -- are manufacturers incapable of purifying the peptide beyond this point? Most perplexing; the Janoshik Special Method sounds wonderful!

I defer to you gentlemen to educate me on why one methodology might see 99%+ purity versus 96.5%, or zero dimer versus a >0 quantity.

Well, @Chromate did one useful thing here and provided the ancient pharmacopoeia.

http://www.uspbpep.com/ep60/somatropin%20for%20injection%200952e.pdf

The difference is in that Chromate is doing this test:

and he's trying to pass it as a purity test too.

While in fact the purity test, as it understood by general consensus with zero dissenting opinion ( well, maybe with exception of Chromate here ) is this:




With us this test + quantity is the 300 USD test:



(that's what the raw data is actually attached for).

And for additional 120 USD you're getting this from us as well:



He probably doesn't even understand the difference, poor thing.

tldr: he's trying to sell you a 120 USD worth of test as... how much did you even get charged?

 

[janoshik]

You have become accustomed to expecting ~96.5% purity -- are manufacturers incapable of purifying the peptide beyond this point? Most perplexing; the Janoshik Special Method sounds wonderful!

Yeah, screw Pfizer and Serono, Chromate at his basement knows better, everything is 99% in his world, but somehow he cannot even manage to test methenolone enanthate or testosterone in blind tests, infinitely more simple molecules than GH.

Solely bad luck I guess, but he might start a new thread just in case.

The Separation of Recombinant Human Growth Hormone Variants by UHPLC

Abstract. Reversed-phase ultra-high-performance liquid chromatography (RP-UHPLC) was used for the separation of recombinant human growth hormone (rhGH) var

academic.oup.com

Mass spectrometrical analysis of recombinant human growth hormone (Genotropin®) reveals amino acid substitutions in 2% of the expressed protein - PMC

The structural integrity of recombinant proteins is of critical importance to their application as clinical treatments. Recombinant growth hormone preparations have been examined by several methodologies. In this study recombinant human growth ...

www.ncbi.nlm.nih.gov

https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20604s029lbl.pdf

 

[Chromate]

Well, @Chromate did one useful thing here and provided the ancient pharmacopoeia.

You are welcome—we always utilize the highest quality resources in our work. With perfect implementation of the ancient pharmacopoeia method we successfully detected dimer where your modern proprietary method has failed. However we are also happy to admit fault when it occurs, as it has with respect to the overall purity measurement. We will implement the ancient pharmacopoeia’s purity method and use @GGC's spare samples for further analysis.

 

[janoshik]

Nothing like missing the teensy weensy detail of not actually running the test the client paid for at all, not understanding the very nature of the tests you run and still acting uppity.

I mean - is there an interlaboratory test this cargo cult of a lab have not failed at this point?

Do you have no shame at all?

Jesus.

 

[lift4lyfe]

Nothing like missing the teensy weensy detail of not actually running the test the client paid for at all, not understanding the very nature of the tests you run and still acting uppity.

I mean - is there an interlaboratory test this cargo cult of a lab have not failed at this point?

Do you have no shame at all?

Jesus.

Appreciate if you can explain like we’re 5 years old why Chromate “successfully detected” dimer while you detected 0% dimer. What did Chromate detect if it wasn’t dimer?

 

[Chromate]

Nothing like missing the teensy weensy detail of not actually running the test the client paid for at all, not understanding the very nature of the tests you run and still acting uppity.

I mean - is there an interlaboratory test this cargo cult of a lab have not failed at this point?

Do you have no shame at all?

Jesus.

I do sincerely apologize, the confidence was brought on by the fact that your method erroneously failed to detect any dimer — and as you have correctly ascertained: the analytical method we employed was for dimer analysis. The method was even verified on our instruments by the detection of ~0.5% dimer in EP Somatropin CRS Batch 4, which agrees with the international collaborative study.

So it seems both labs have made a mistake, but only one can admit it.

The appropriate supplies are being gathered and additional purity testing will be performed on these samples. We have never done a client wrong.

Lastly, we thank you for the lesson in decoding the ancient pharmacopoeia; it wasn’t totally clear that ‘related proteins’ was specific to general purity.