mands's picture
mands
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+ 4 MALDI-TOF-MS/HPLC-UV-VIS rHGH results

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Please see attached for copies of the MS and HPLC on the Western Biotech. These are 10 iu vial not 20 iu vials.

Sorry for the word SAMPLE across the pages. Used a converter because eroids will not let you load PDF's.
mands

Ordered from: 
HailRazor's picture

LMAO!!!
Ya Know......with all this 'Hi Tech' testing.....at the end of the day.....BigWilly's "Mirror Test" might be the most accurate test of them all. True Story. :))

HailRazor's picture

There seems to be lots of apples lately

HailRazor's picture

I'd like to know too. Here's some other info:

SIMEC.ch (from a test by them)

The Somatropin Standard CRS injected in the prescribed amount of 40ug gave a single peak in the chromatogram with reproducible peak area. The average value from three runs of the standard was used for calculation of the other samples. The injection of 10ug of the standard resulted in detection of 8.8ug Somatropin, probably due to less injection precision with smaller volumes.

Aliquots of 10ul/ug 40ul/ug 25ul/ug were used in the Soma test.

Omnitrope Sandoz:

5.8mg vial: After reconstitution, the concentration is 5mg/mL

GH is a fragile protein...not sure how the test adjusts for concentration, or if it has to adjust at all

3.72mg/mL (52,121,286) standard/reference
1.36mg/mL (19,022,564) calculated sample concentration (Soma)

HailRazor's picture

(PhD in StreetPharmacy......so this is just my understanding)

In both cases, AS1743-1 (Soma Orange Cap) and the protein standard solution (3.72mg/mL), aliquots of 10ul were added to 40ul ultrapure water. An aliquot of 25ul was injected.

Concentration of Sample AS1743-1 - 1.36mg/mL

I am curious about the GH Standard/Reference used (3.72mg/mL) (3.33mg)

I've only seen that mg amount on the old 100iu Jintropin Chinese Kits

According to the test/tester:

The quantity is in question, not the quality

But, according to the GH Serums, the quantity should have been on point.

HailRazor's picture

(So I've read)
The precise conversion (1mg = 2.7IUs)
3.72mgs * 2.7ius = 10ius (approx)

I'm assuming the GH Standard is/was specifically for this test (Sigma-Aldrich, etc)
I don't know enough about how the testing is done, but I'd like to learn more

Couple of other "Generics" I'd like to see tested. It seems using Blood Work to test a product Vs testing the actual product (Day n Night)

HailRazor's picture

https://www.eroids.com/sites/default/files/gearpic/21800/image_79.jpg

10iu labeled vial (tested 1.06mg) These tested ok with Serum and IGF1 (using the inject an entire vial "spiking the serum" protocol)

Beings that this Soma test is showing a legit GH Protein....I don't think it is "underdosed" but probably accurately dosed. 4iu, 8iu,10iu, etc. (normal packaged doses)

If this test is accurate, Karl should embrace this test as it is showing an authentic product that may have just had a "mislabeling mg/IU" issue.

Victor D's picture

they don't sell 4IU vial.

they scam ppl selling 10IU vial with just 4 IU of real HGH in it.
Real hgh ok, but still damn underdosed! for that price I can go pharma grade, If i have to multiply the doses for 2,5 to get what I want.

HailRazor's picture

I'm trying to be "politically correct".

:))

Victor D's picture

So it's still not explained if the IU were correct or not.

Because it's useless to have 99% pure HGH if the vial is advertised as 10IU but it's in reality 4.

Anyone care to shed some light?

Sciroxx's picture

If you follow the calculation below on my former post (here it is again 3.72 mg/ml (GH standard) / 52,121,286 (peak area)} x 19,022,564 = 1.36 mg/ml.) - you'll see that there are about 3.7mg in the vials which are about 11iu, and indeed we overdose products in 10%

Victor D's picture

you are full of bullshit karl, and you sell an underdosed product. there is no more then 4IU of HGH in your vial.

The following are reasons an entire 1 ml vial CAN NOT or NEED NOT be tested
-All HPL analyses required multiple runs to improve accuracy
- Large volume injections can exceed the HPLCs pressure or volume tolerances
- Either can cause a grid blow out, a situation in which the pressure alone FORCES the sample thru the grid and down the DRAIN
- Micro liter sampling has become the norm since the adaptation of High Pressure (Low Volume) Liquid Chromatography systems. The primary reason HPLCs are used is the minute sample requirements.
- Finally providing the sample constituents are in equilibrium with the solvent being utilized the results, which are based on WELL ESTABLISHED DILUTION FACTORS, will be VERY ACCURATE with a margin of error approximating 0.05 mg/ml, as was listed in this instance!

1.36 mg/ml that's the quantity of HGH in your vial, it's should be around 3.72mg/ml

0.33 mg = 1IU
1.36mg/0.33 = 4,12IU

so you sell 10IU vial with 4.12IU of hgh in it, and you fucking tried to says: we overdose the product! give me a break and fuck off.

Sciroxx's picture

First my team didn't conduct this test, I just offered an interpretation,

Now you're making a fool out of yourself, and the only reason I'm the only one to call you out is that the members here doesn't understand in analytical chemistry ....

  • The test was done according to a perfect protocol, sample was run as it should, not sure if you "googled" and posted some irrelevant data, or you simply post here some high language facts that are irrelevant to the method or results to confuse the members. The test was taken on a USA university, and the result by them as you may confirm with the person who posted found 10iu per via, actually a little more.
  • It's a shame that an adult person doesn't differ between a concentration (mg/ml) and total volume/weight. Here is the authorized calculation again -

A rHGH standard with a known amount of protein was used for the calculation. In both cases, AS1743-1 and the protein standard solution, aliquots of 10 µl were added to 40 µl ultrapure water. An aliquot of 25 µl was injected.

{3.72 mg/ml (GH standard) / 52,121,286 (peak area)} x 19,022,564 = 1.36 mg/ml - the total content of HGH powder is 3.72mg = 11iu

Victor D's picture

You are twisting your words so ppl read that it's 11IU but it's not.

Did you read the report?
IT SAYS: the observer concentration of the sample solution: 1,36mg/ml

it should be 3,72mg/ml SAME AS THE STANDARD GH!

You are again full of bullshit and trying to call me a liar or dumb is not working. this test PROVE that your HGH is pure but damn UNDERDOSED.

Better buy pharma gh if I have to pay: 2x to get the same dosage.

Victor D's picture

no there are: 1.36 mg/ml
unless I don't understand it (probably this is the case).

explain it better please or in a simpler way

EDIT: After further research I have understood that I was right and karl a liar.

Sciroxx's picture

Check below ... I asked the head professor from my team for a brief explanation to this specific test, including the specified calculation on the numbers. Hereinafter is his reply -

==================================================

See attached the text. It’s based on the original text in your HPLC report + my modifications. I hope it’s what you are looking for.
==================================================Below is the content of the attached file he sent me with the info -

  1. INTRODUCTION:
    This report summarizes the analysis of human growth hormone sample obtained from (SOMAS) batch no : AS1753-1 and was compared to innovator product Norditropin from Novo Nordisk as per the methods mentioned in British Pharmacopeia (BP). The biosimilarity assessment includes HPLC.

Analytical HPLC of the protein sample was performed using a reversed-phase C18 column and absorbance monitoring at 210 nm and 280 nm. After the weight of the sample was determined using an analytical micro balance, it was mixed with one ml of the required HPLC testing solution

Please note: Proteins and peptides absorb UV light in the range from 200 to 300 nm but have absorbance maxima at 210 and 280 nm. The absorbance at 210 nm is much higher than at 280 nm. However, the absorbance maximum at 280 is specific for proteins. The integration of the chromatogram trace covers the range of the chromatogram in which proteins and peptides elute from the column.

  1. OBJECTIVE
    This report describes the analysis of human growth hormone sample obtained
    from (SOMAS) batch no: AS1753-1 as per the methods described in British
    Pharmacopeia.

  2. SCOPE
    This report applies to the analysis of human growth hormone sample obtained from (SOMAS) batch no : AS1753-1 as per the methods in British Pharmacopeia in order to display its biosimilarity to the innovator product Norditropin.

  3. TESTS: HPLC
    Weight of the solid powder: 24.2 ± 0.25 mg present in the vial.

The observed concentration of the sample solution = 1.36 mg/ml ± 0.05 mg/ml.

Calculations:
A rHGH standard with a known amount of protein was used for the calculation. In both cases, AS1743-1 and the protein standard solution, aliquots of 10 µl were added to 40 µl ultrapure water. An aliquot of 25 µl was injected.

{3.72 mg/ml (GH standard) / 52,121,286 (peak area)} x 19,022,564 = 1.36 mg/ml.

jimmycrackcorn's picture

So is this saying these are 99% pure?

mands's picture

This batch is 99% pure. I believe the first 20 iu batch I tested last year was 98% pure.

mands

HailRazor's picture

mands's picture

If anyone has a better converter I can send PDF's to them and have them re-post as .jpg's

mands

HailRazor's picture

Mands can you explain the slight difference in MW? I never get much response on that subject.

This sample seems close, just not 3.33mgs (10ius) 1.36mg/mL (apprx 4IUs)
GH Serums seemed to be "on point"

TY

mands's picture

I'll try and explain a couple questions here. There is a MW range that pharmacy grade GH may fall within.

With that said things that can alter that weight is missing proteins, incorrect folds in sequence, wrong sequence, etc. These can all cause issues. Some harmful and some not. For example red welts at injection site, more water retention possibly. Also incorrect fold can cause health issues.

Really what we need is more biological assays so we can determine of these generic are raising IGF-1 levels. Even 191aa gh that's short a protein can cause a spike in gh levels but hardly raise IGF-1 levels.

I'm on my phone and when I get back Monday I will get on my desk top and go into it a little deeper if needed.

mands

HailRazor's picture

(This isn't about Karl's sample as it seems to test very close to the GH Standard/Reference)

There were two popular UGL GH products that tested:
2 Peaks: (22,411,4 Da - 22,145,2 Da)
Elevated both GH Serum and IGF-1
Wondering if this would be more prone to Immunogenicity, (Non)- Neutralizing Antibody, Tolerance, etc. Doesn't seem to fall within Pharma Range.

I've seen a few test results showing 176AA (20,270 Da)
I wonder how that would test with Serum/IGF1

FR sent

Sciroxx's picture

I'm intrigued myself, may u send me a sample ? as there certainly should be 2 peaks !!!!

HailRazor's picture

Sent u a Pm

Sciroxx's picture

The sample is tested after dissolved in water, so the number u refer to (1.36mg/mL) represent concentration per ml as you see, not total mg's in the sample. if you follow the calculation you'll see the total mg's of protein is more then 3.33mg (10iu)

I'll get in a couple of hours a brief from my professor including the full calculation on this specific test, no worries

HailRazor's picture

Thanks Karl

I'm always wanting to learn more about the testing

3.72 mg/mL (GH Standard/Reference used)
1.36 mg/mL (observed concentration of sample)(calculated)

I did post a few HGH samples (HPLC) from SIMEC

Sciroxx's picture

It depends on the concentration of the solution, if u dissolve 10iu for instance in 3ml ... or 1 ml, I'll post in one min' the whole explanation and specified calculation from my professor on this specific test

Look on top in one minute