Simeglutide Series |
Product Name & CAS |
Completion of a pharmacy fellowship or not |
batch |
Recombinant side chain for fermentation |
tBuO-Ste-Glu(AEEA-AEEA-OH)-OtBu CAS:1118767-16-0 |
Yes, DMF has been declared as an annex to the CDE |
40kg/batch |
tBuO-Ste-Glu(OtBu)-AEEA-AEEA-OSU CAS:1118767-15-9 |
In progress, conducting methodological studies up to the finished product |
10kg/batch |
|
Ste-Glu-AEEA-AEEA-OSU CAS:1169630-40-3 |
Yes, DMF has been declared as an annex to the CDE |
10kg/batch |
|
Side Chain for Solid Phase Synthesis |
Fmoc-L-Lys[Oct-(OtBu)-Glu-(OtBu)-AEEA-AEEA]-OH CAS:1662688-20-1 |
Yes, DMF documents are in the translation stage for filing with FDA |
40kg/batch |
Chengdu Pukang Biotechnology controls couplable impurities such as homologous impurities, missing and misjunction peptides, and isomer impurities as important impurities tBuO-Ste-Glu(AEEA-AEEA-OH)-OtBu (CAS:1118767-16-0)
Mapping of the applicability of the substance system in question:
Isomer system suitability mapping:
Ste-Glu-AEEA-AEEA-OSU(CAS:1169630-40-3)
Relevant Substance 1, Relevant Substance 2 System Suitability Mapping:
Relevant substance 1
Relevant substance 2
Fmoc-L-Lys[Oct-(OtBu)-Glu-(OtBu)-AEEA-AEEA]-OH(CAS:1662688-20-1)
Mapping of the applicability of the substance system in question:
Isomer system suitability mapping: