compared some commoan brands of Gh

[Mr.Wong Member Find all posts View Profile Close Mr.Wong]

Nope oc not, it is used as part of the analyses to look for deviant MM-es. Just look at all the analyses I posted in the blog.
But.. we also do the HPLC, but not on a;ll samples. Most raws are being produced in a few places. They are sold under differnt brandnames.
I attach a very recent lab analysis of CP.

How much you paid for the Identification and Assay? How was the assay performed (SEC)?

[RonnyT Senior Member Find all posts View Profile Close RonnyT]

How much you paid for the Identification and Assay? How was the assay performed (SEC)?

We use the lab for a long time even in my Body of Science time, also visited the lab, thus our price is not what everyone pays ( I hope).

[PROFI-ROIDS Junior Member Find all posts View Profile Close PROFI-ROIDS]

How much you paid for the Identification and Assay? How was the assay performed (SEC)?

who r u ? shown u r from HKG?

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Nope oc not, it is used as part of the analyses to look for deviant MM-es. Just look at all the analyses I posted in the blog.
But.. we also do the HPLC, but not on a;ll samples. Most raws are being produced in a few places. They are sold under differnt brandnames.
I attach a very recent lab analysis of CP.

trusted lab for 110%

[Mr.Wong Member Find all posts View Profile Close Mr.Wong]

Nope oc not, it is used as part of the analyses to look for deviant MM-es. Just look at all the analyses I posted in the blog.
But.. we also do the HPLC, but not on a;ll samples. Most raws are being produced in a few places. They are sold under differnt brandnames.
I attach a very recent lab analysis of CP.

OK but considering this is chinese GH, peptide fingerprint and coverage would be mandatory. Even though the Assay points out high IU (I wonder why they wrote the Assay in IU since they can't basically know how many IU's are there they can only know how many milligrams). As everybody knows, chinese GH has considerably lower biological activity than original GH or biosimilars like Omnitrope. That's the reason why no chinese GH can basically be registered in EU or US, even though is a huge market and profit, they can't register under the Biosimilars regulations. So... I'd be skeptical about this HPLC and main reason is the Assay being written in IU, which is a technical script error IMO.

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who r u ? shown u r from HKG?

I'm not sure I understand where your question is coming from, we're on a forum where everybody uses a pseudonym...

[PROFI-ROIDS Junior Member Find all posts View Profile Close PROFI-ROIDS]

OK but considering this is chinese GH, peptide fingerprint and coverage would be mandatory. Even though the Assay points out high IU (I wonder why they wrote the Assay in IU since they can't basically know how many IU's are there they can only know how many milligrams). As everybody knows, chinese GH has considerably lower biological activity than original GH or biosimilars like Omnitrope. That's the reason why no chinese GH can basically be registered in EU or US, even though is a huge market and profit, they can't register under the Biosimilars regulations. So... I'd be skeptical about this HPLC and main reason is the Assay being written in IU, which is a technical script error IMO.

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I'm not sure I understand where your question is coming from, we're on a forum where everybody uses a pseudonym...

in fact market in China is so big so Chinese companies have no real interest to register in EU or USA.
but anyway - which lab do u reccomend? maybe I will do there some

[Mr.Wong Member Find all posts View Profile Close Mr.Wong]

in fact market in China is so big so Chinese companies have no real interest to register in EU or USA.
but anyway - which lab do u reccomend? maybe I will do there some

That's the most hilarious argument I heard in months. As if Chinese HGH manufacturers could pass the biosimilars regulations of EMA/FDA but they don't care about this markets.

EMA approved its first biosimilar for somatropin (Omnitrope) back in 2006. To date, the agency has approved 14 biosimilars for use in the EU, within the product classes of human growth hormone, granulocyte colony-stimulating factor (G-CSF) and erythropoietin [2].

In Europe, guidelines are already in place covering general topics such as quality, efficacy and safety, as well as product specific issues concerning, e.g. soluble insulin, human growth hormone (somatropin), G-CSF erythropoietins, interferon-alpha, low molecular weight heparins and monoclonal antibodies [3].

In the US, however, the situation is somewhat different. Although a legal pathway was put into place with the signing into law of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) on 23 March 2010 by President Barack Obama, FDA is still in the process of developing guidelines regarding these types of products [4].

A comparison of the biosimilars pathways in Europe and the US is given in Table 1.

[PROFI-ROIDS Junior Member Find all posts View Profile Close PROFI-ROIDS]

so only suggestion from u and no any correct info about lab?

[rocky.b Junior Member Find all posts View Profile Close rocky.b]

what do you think?

[RonnyT Senior Member Find all posts View Profile Close RonnyT]

Chinese

...As everybody knows, chinese GH has considerably lower biological activity than original GH or biosimilars like Omnitrope. That's the reason why no chinese GH can basically be registered in EU or US...

I absolutely disagree. If the Chinese want they can even produce better quality than pharma grade European somatropin. I have a comparison somewhere that Ed made.

In 2006 we asked the University of Leuven Belgium to analyse Jintropin. As you know John (Jin) was a brilliant Chinese student that left the US to ensure that cheap top quality rhGH became available to the Chinese. You can read the whole story on our blog. On the boards everybody doubted the quality of Jintropin and was so brainwashed to believe the myth of superior US technology and quality.

Professor. Dr. J. TYTGAT, head of the laboratory for Toxicologie at the University to Louvain (K.U.Leuven) performed the analyses. A sample we bought on the Dutch black market and send to Prof. Dr. Jan Tytgat. He ensured me that the quality was excellent, as fresh snow..lol..

Oc The US will never allow to share their part of the drug market. They rob billions of severe ill people. If the market would become a free market. Chinese and Indian companies would blow away Big Pharma. You should know what something like Viagra costs to produce and what the salesprice is. Who make these outrageous profits..? Pfizer and indirectly USA. Same with rhGH, but they will never be able to stop cheap imports. These imports/smuggle already caused a lower price..

You are right that generally speaking some of the sellers - middleman and suppliers sell bad or very bad quality Chinese rhGH. But that doesn't mean the Chinese are unable to make pharma grade quality.

[RonnyT Senior Member Find all posts View Profile Close RonnyT]

last

..and the last graphic..

[RonnyT Senior Member Find all posts View Profile Close RonnyT]

I really care for this subject thats why I'll attach some relevant links.
http://juicedmuscle.com/jmblog/conte...asured-rp-hplc
http://juicedmuscle.com/jmblog/conte...hormone-part-1
http://juicedmuscle.com/jmblog/conte...hormone-part-2
http://juicedmuscle.com/jmblog/conte...hormone-part-3
http://juicedmuscle.com/jmblog/conte...hormone-part-4
http://juicedmuscle.com/jmblog/conte...ent-conditions

[RonnyT Senior Member Find all posts View Profile Close RonnyT]

To better understand what Wong means:
An IU (international unit) is just a volume like liter or milliliter. You determine the strength of a GH product by how many milligram Somatropin it contain at 10iu and not at IU alone. the dosage vary from manufacturer to manufacturer , they all sell 10iu vials but they are not all containing the same amount of somatropin for example XXX contain 4mg at 10iu and 3.2 at 8iu where YYY contain 3.7mg at 10iu and most ZZZ 3.33mg at 10iu if they are from a good source of course.

IU, International Units are not a volume measurement.

It is a unit of measurement that is determined for specific compounds, based on a predetermined amount of biological effect. So 1 IU of insulin corresponds to a specific amount of insulin that is different from the amount of GH 1 iu describes.

The reason why different GH manufacturers have different amounts of GH (somatotropin) per IU, is that their product might be better or worse per mass unit (mg) to induce a biological effect.

[Mr.Wong Member Find all posts View Profile Close Mr.Wong]

I think I have been pretty clear in my previous posts. Things are much easier to understand the way I put it:

I.U. - biological activity of a molecule. The patient cares only about this as long as the molecule works identically as the 100% pure molecule.
mg - weight of the molecule.

While by SDS, HPLC-RP, HPLC-SEC, MALDI-TOF, etc you can determine more or less only the weight and not the biological value, patients shouldn't be much interested in the miligram results from the HPLC. Some brands overdose by a lot but having low purity low biological value molecules (due to manufacturing process pathways, for example intraplasmatic or inclusion bodies). So while RonnyT posts interesting HPLC results showing up the miligram, I wouldn't agree by far with its assertion of biological value (IU) since it can't really be determined without exhaustive bio-equivalence testing (complex procedure).

Regarding the capacity of chinese manufactureres to make Western Grade Somatropin, just take a tour through Gen's factory in Jilin and then try to visit any foreign manufacturer. Differences are huge. Differences in the equipment, practices, methods, are HUGE. Yes, there is no doubt Jintropin can sometimes match the quality of Genotropin, Humatrope or others alike. No doubt they have matched times and times again. But pharma manufacturing is not about seasonal achievements, its about QbD, stability and persistence, in which Chinese manufactureres (including GenSci) are far away to even understand. Gen Lei is a scientist, not a pharmaceutical manufacturer expert neither an example of ethics or business integrity. If you have the time RonnyT read the Biosimilars act and the regulations for achieving biosimilar status by FDA or EMA. Its fucking HARD CORE regulating regarding the whole biosimilars and huge companies like Novo Nordisk, Lilly are failing one after another to create biosimilars ready to be registered, the pipelines for the whole biopharmaceutical drugs are full and the finality is less than 20 biosimilars in the last 10 years. Think about that. Of course from bodybuilders point of view, the pharma quality Chinese GH is good and absolutely worth every penny. From FDA/EMA regulators point of view, they're far from perfect. What's the difference between West and China/India? Ethics, integrity, risk awareness, legitimacy. GenSci was selling stuff to US and wherenot accepting WU payments and sending products in normal non-thermal boxes to anyone without asking anything, not even a script. You think these practices are not maintained into their day to day operations? I think they are, in fact I know they are.

Chinese manufactureres or Indian ones ability to manufacture high quality goods is not the question, the question is their will and search for high quality. They prefer cheap and so/so.

[Mr.Wong Member Find all posts View Profile Close Mr.Wong]

I have one question for you RonnyT: why you think bio-equivalence testing and pharmacological investigations are mandatory for the registration of any molecule (existing in the BP/EP/USP) in US/EU? Why isn't FDA or EMA accepting just analytic testing, after all a molecule that has the same Molecular Weight or same peptide finger-print should behave identically the same effect as other with the same characteristics right? Well, its not the case most often. Solubility affects a lot the bioavailabilty of the somatropin molecule, identically the same molecular weight and peptide fingerprint but differences in their solubility can make a big difference. This is just one example there are plenty more parameters in which molecules assessed as identical by analytic testing differ. That's why, at the end of the day, after all the parameters are identical, EMA/FDA requests bio-equivalence testing to prove the pharmacological effects are identical. It goes the same route even for Aspirin, a basic and old compound. If you want to register Aspirin and buy the raw material from Bayer, you need to supply the bio-equivalence dossier. Go figure in case of bio-similars which are heaps more complex.