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Chengdu Pukang Bio's Simeglutide Series

Publish Time: 2024-12-20

 

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:

IMG_256

Isomer system suitability mapping:

IMG_256

Ste-Glu-AEEA-AEEA-OSU(CAS:1169630-40-3)

Relevant Substance 1, Relevant Substance 2 System Suitability Mapping:

IMG_256

Relevant substance 1

IMG_256

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:

IMG_256

Isomer system suitability mapping:

IMG_256