I beleive you mixed 2 points which is important to understand.
Purity: RP-HPLC (EP 8.0) should be> 94% -> the content of similar proteins with less biological activity than
GH, in acc.with Pharmacopoeia concentration of similar proteins should be less than 6%.
Dimers and aggregates: SEC-HPLC (EP 8.0) should be> 96% -> High molecular weight admixtures of somatotropin and products of its physical degradation.
It characterizes the immunogenicity of the drug and ability to induce an immune response. The more concentration - the stronger immune response neutralizing growth hormone, in acc.with Pharmacopoeia concentration of dims/aggs should be less than 4%.
Our GH on this report tested only on
Purity but not for
Dimers and aggregates. And in theory it may happens because of doubled dosage of GH.
@janoshik is I'm right when I talked about your protocol and tests your done??
When we talk about general health status - most importnatn is
Endotoxines. Immune reaction -
Dimers and aggregates
P.S.
Endotoxins - molecular components of membranes of microorganisms, which have a toxic effect on the mammalian organism. Endotoxins can provoke chronic hyperactivation of the immune system and lead to critical consequences for the whole organism. In acc.with Pharmacopoeia concentration should be less than 5 UI/mg.