OP I don't know if your question was answered but suspect a bit of elaboration may help.
When Pharma mentions purity of their GH what is being referred to is what percentage of the PROTEIN POLY-peps are GH rather than GH subunits or "iso-forms"
That's bc unlike generic, Pharma
already has genome evidence their E-coli WILL PRODUCE a 191 AA GH molecule BUT what is somewhat unknown is the frequency of genetic errors.
It's the "errors" that can result in the production of GH sub-units or isoforms, and this can certainly be important bc few isoforms possess intrinsic bioactivity, esp on par with
the legit GH!
So in this instance a "purity" of close to 95% matters little with respect to efficacy, at least according to the FDA
bc that's what is required.
It is defined in the pharmacopoeia and it is not defined as you had stated it.
Rest of the post is just nonsense.
Do you really believe that the manufacturers of generics are
bioengineering their own bacteria manufacturing HGH? And they actually succeed in doing so, but accidentally use wrong gene?
Because doing that would imply degree of knowledge unparalleled to pretty much anybody in the game of illegal hormones and a schoolers mistake and as I am firm believer in occams razor, I don't think that's the case.
You also need to understand however I've yet to see ANY evidence generic GH has purifies of 95% bc every HPLC that I've reviewed have a very narrow window of visualization.
This means other peaks may be present yet could have been omitted, since the elution time window is set to "catch" only GH, and if no other peaks are present the purity can readily be stated as being > 99%!
In addition since generic manufacturers have not published (nor will they) genomic evidence, one should NOT assume the AA sequence or proportions approximate that of Pharma.
Finally these QUALITATIVE questions
- is the sequence correct
- are the Amino Acid proportions correct
- are other proteins, poly-PEPs, subunits or isoforms present AND if so what is their percentage AND how such changes effect overall "purity"
- can not be answered with a reasonable degree of certainty using an AAA
I hope that helps
Jim
You do not know what you are talking about.
What is 'narrow window of visualisation'? Sounds like term pulled out of somewhere to me.
Elution time windown to catch only GH? How are you even courageous enough to spout
bullshit like this?
NONE of the methods used or out of those I have ever seen is like that. Only an amateur without any sense of what HPLC testing of proteins looks like could say something like that.
ALL THE METHODS PUBLIC AND NOT PUBLIC I HAVE EVER SEEN, and I've seen dozens, call for run times much longer than those that would be necessary to 'just catch' HGH. Also, there are things like flushing the column and of course there is SEC, where you know EXACTLY after how many ML of mobile phase it is GUARANTEED everything had eluted. Combined with short times necessary for SEC how in the world do you think anybody would run it shorter than that?
With RP HPLC it can be estimated VERY WELL when everything had eluted as well, that's what modifiers and gradients are for.
Only thing I can agree with you here is that AAA is far from ideal test for HGH.
Oh an let me also state the notion an ELISA assay can be used to determine GH "purity" is
utterly absurd bc ELISA testing is SPECIFIC for ONE molecule and can NOT differentiate a 191 AA GH from one that contains 192 AA (or any other GH isoforms or subunit) NLESS a specific test was developed explicitly for that purpose.
Thus bc ELISA can not rule out the presence of significant quantities of protein based genomic production impurities a
ELISA purity listing is dubious at best if not outright bullshit IMO.
(Unless someone can cite ANY company that manufactures and sells such a product for use in analytical labs, NOT)
Where exactly did anybody ever state ELISA can determine purity?
I don't really remember about anybody but my using immunoassays for analytical testing of GH, so I will assume you are talking about me - so I'll be happy if you'd quote me on that.
Only thing I have stated is that ELISA is extremely PRECISE QUANTITATIVE test, which is a statement I still stand behind as I do usually stand behind my statements.
Unlike somebody who contradicts himself on facts on the same page of some some threads.
I am sorry for the tone of the post, but first, MISINFORMATIONS AND LIES MAKE ME ANGRY and second, when I tried to make my coffee (see post above) my coffee maker literally exploded, so my addiction is not sated.
