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Stability Data for LongTMR3IGF-I (Liquid Formulations)
The stability of a liquid solution of LongTMR3IGF-I was monitored for a period of two years at storage conditions of -20 C, +4 C, +22 C, and +37 C. The final concentration of LongTMR3IGF-I was in acetic acid. At various time points, samples were taken and compared to a lyophilized control (stored at 4 C). Listed below are the stability results for each respective storage condition.
Storage Condition: -20 C
Biological Potency No Change up to 2 years
Immunological Activity No Change up to 2 years
Mobility of Protein No Change up to 2 years
Elution Profile by reversed phased HPLC No Change up to 2 years
Storage Condition: +4 C
Biological Potency No Change up to 2 years
Immunological Activity No Change up to 2 years
Mobility of Protein No Change up to 2 years
Elution Profile by reversed phased HPLC No Change up to 2 years
Storage Condition: +22 C
Biological Potency No Change up to 2 years
Immunological Activity No Change up to 2 years
Mobility of Protein No Change up to 2 years
Elution Profile by reversed phased HPLC No Change up to 2 years
Storage Condition: +37 C
Biological Potency No Change up to 1 year
Immunological Activity No Change up to 1 year
Mobility of Protein No Change up to 1 year
Elution Profile by reversed phased HPLC No Change up to 1 year
Conclusions
o There is no significant difference in the potency of LongTMR3IGF-I associated with the storage of the liquid formulation when stored at this range of temperatures.
o There is no evidence for loss of biological activity at any of the tested temperatures when stored as a liquid product.
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Jak widać LR3 IGF-1 nawet przez rok może być przetrzymywane w temp 37 C nie tracąc swych właściwości... Jaki z tego morał??? Do dzieła przemytnicy!!!