1) pls check this assay from SIMEC (swiss testing labs )
Pictures - GODTROPIN / PURETROPIN
GODTROPIN 12IU VIAL (Batch No. 010415)
15IUs
3.9% RELATED PROTEINS
0.7% DIMMER AND RELATED SUBSTANCES
PURETROPIN 10IU VIAL
BUNK
GODTROPIN 12IU VIAL FROM Juicyj23 (welts)
53.1IUs
1.7% RELATED PROTEINS
0.2% RELATED SUBSTANCES
GODTROPIN 12IU VIAL FROM Juicyj23 (welts)
57.8IUs
4.7% RELATED PROTEINS
0.1% RELATED SUBSTANCES
The European Pharmacopoeia (Pharmacopoeia Europaea, Ph. Eur.) is a pharmacopoeia that aims to provide common quality standards throughout Europe to control the quality of medicines and the substances used to manufacture them. It is a published collection of monographs that describe both the individual and general quality standards for ingredients, dosage forms and methods of analysis for medicines. These standards apply to medicines for both human and veterinary use.
RELATED PROTEINS
All of the non-hGH proteins coexist with the main ingredient (rhGH). Impurities influence the rhGH activity and cause side effects. The fewer impurities one product have, the better quality it has .
Testing method: HPLC (To assay the percentage of rhGH and the impure proteins in the product)
Standard: According to European Pharmacopoeia 5.0 (Page2463-2464), the content of related protein of somatropin should be no more than 6.0 %
Result:
2) DIMMER AND RELATED SUBSTANCES OF HIGHER MOLECULAR MASS TEST
Dimmer and related substances of higher molecular mass: rhGh aggregates that coexist with normal rhGh. They don't have biological activity and cause antibody of rhGH. The antibody combines to rhGH molecule. The antibody prevents the rhGH from combining to its receptor to stimulate growth, cause the biological activity of rhGH to decrease.
Testing method: HPLC (To assay the percentage of active protein and the impure proteins in the product) Standard: According to European Pharmacopoeia 5.0 (Page 2464), the content of dimer and related substances of higher molecular mass of somatropin should be no more than 4.0%
BACTERIA ENDOTOXINS TEST
BacteriaEndotoxins:
To assay the amount of bacteria endotoxins .
The More bacteria endotoxins present will increase the adverse and toxic effects of the rhGH.
Results:
According the specification of Pharmacopoeia of the People's Republic of China (2000 Edition) and European Pharmacopoeia 5.0, the content of bacterial endotoxins should be no more than 5 EU.
ELISA - TEST OF E.COLI DERIVED PROTEIN
The more the host-cell-derived (E.coli) proteins present, the more toxic and adverse effects there will be caused.