| CHA. | Imikhiqizo | Inombolo ye-CAS. | Isicelo | Inkomba Yekhwalithi Ebalulekile | ||||
| Ubumsulwa | Isomer | SI * | Ubukhulu * | Umswakama | ||||
| 1 | I-Fmoc-Ls(Mtt)-OH | 167393-62-6 | Lysine side chain ukuguqulwa | ≥99.0% | ≤0.1% | ≤0.2% | ≤0.3% | ≤1.0% |
| 2 | I-Fmoc-Ls(Alloc)-OH | 146982-27-6 | Lysine side chain ukuguqulwa | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤1.0% |
| 3 | I-Fmoc-Ls(ivDde)-OH | 150629-67-7 | Lysine side chain ukuguqulwa | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
| 4 | I-Fmoc-Ls(Mmt)-OH | 159857-60-0 | Lysine side chain ukuguqulwa | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
| 5 | I-Fmoc-Glu-OtBu | 84793-07-7 | I-LiraglutideI-Semaglutide | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤1.0% |
| 6 | Glu-OtBu | 45120-30-7 | I-LiraglutideI-Semaglutide | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤1.0% |
| 7 | I-Octadecanedioic acid | 871-70-5 | I-Semaglutide | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 8 | I-Octadecanedioic acid mono-tert-butyl ester | 843666-40-0 | I-Semaglutide | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 9 | I-tBu-OOC-C16-CO-Glu-OtBu | 1188328-39-3 | I-SemaglutideIsiqephu A | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 10 | AEEA | 134978-97-5 | I-SemaglutideI-Albuvirtide | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 11 | I-AEEA-OH.HCl | 134979-01-4 | I-SemaglutideI-Albuvirtide | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 12 | Fmoc-AEEA-OH | 166108-71-0 | I-SemaglutideI-Albuvirtide | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 13 | Boc-AEEA-OH | 108466-89-3 | I-Semaglutide | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 14 | AEEA-AEEA | 1143516-05-5 | I-Semaglutide | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 15 | Fmoc-AEEA-AEEA-OH | 560088-89-3 | I-SemaglutideIsiqephu B | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 16 | I-Octa(OtBu)-Glu(ɑ-OtBu)-AEEA-AEEA-OH | 1118767-16-0 | I-SemaglutideIsiqephu C | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 17 | I-tBu-OOC-C16-CO-Glu(AEEA-AEEA-NHS)-OtBu | 1118767-15-9 | I-SemaglutideIsiqephu D | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
| 18 | I-Fmoc-Ls(tBu-OOC-C16-CO-Glu(AEEA-AEEA)-OtBu)-OH | 1662688-20-1 | I-Semaglutide Fragment E | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
| 19 | Boc-His(Trt)-OH | 32926-43-5 | Isiphetho yi-histidine | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤4.0% |
| 20 | Fmoc-Aib-OH | 94744-50-0 | I-Semaglutide | ≥99.5% | / | ≤0.1% | ≤0.2% | ≤1.0% |
| 21 | Boc-His(Trt)-Aib-OH | 2061897-68-3 | I-Semaglutide | ≥99.0% | ≤0.1% | ≤0.2% | ≤0.3% | ≤2.0% |
| 22 | I-Fmoc-Glu(OtBu)-Gly-OH | 866044-63-5 | I-analogue ye-GLP-1 | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
| 23 | I-Boc-His(Trt)-Aib-Glu(OtBu)-Gly-OH | 1169630-31-2? | I-Semaglutide Fragment F | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 24 | I-Boc-His(Trt)-Aib-Glu(OtBu)-Gly-NHS | 1169630-40-3 | I-Semaglutide Fragment G | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
| 25 | I-Fmoc-Arg(pbf)-Gly-OH | 660846-80-0 | I-analogue ye-GLP-1 | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
| 26 | Fmoc-Ala-Ala-OH | 87512-31-0 | I-analogue ye-GLP-1 | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
| 27 | I-Fmoc-Thr(tBu)-Phe-OH | 1260609-75-3 ? | I-analogue ye-GLP-1 | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
| 28 | I-Palmitic acid | 1957/10/3 | I-Liraglutide Fragment 1 | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 29 | I-Palm-Glu-OtBu | NA | I-Liraglutide Fragment 2 | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 30 | I-Palm-Glu(NES)-OtBu | NA | I-Liraglutide Fragment 3 | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
| 31 | I-Fmoc-Ls(Palm-Glu-OtBu)-OH | 1491158-62-3 | I-Liraglutide | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 32 | I-Hexadecanedioic acid | 505-54-4 | I-insulin degludec | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 33 | I-Hexadecanedioic acid mono-tert-butyl ester | 843666-27-3 | I-insulin degludec | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 34 | I-tBu-OOC-C14-CO-Glu-OtBu | NA | I-insulin degludec Fragment I | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 35 | I-tBu-OOC-C14-CO-Glu(NES)-OtBu | NA | I-insulin degludec Fragment II | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
SI *= Ukungcola Okuqondile
Ubuningi*= Ukungcola Okungaziwa Okuphezulu
Esinye isikhombi:
I-Acetic Acid: ≤0.02% (Yonke Imikhiqizo)
I-Ethyl Acetate: ≤0.5% (Yonke Imikhiqizo)
- Utshwala: ≤0.5% (Yonke Imikhiqizo)
Ukuhlanzeka kohlelo lokusabalalisa, okuhlanganisa iluphu nethangi lokugcina kwenziwa yi-Pasteurization. Uma kwenziwa i-Pasteurization sanitization, amanzi ahlanzekile ethangini ashisisa aze afike ku-80°C futhi aqale ukujikeleza ngohlelo lokusabalalisa. Ukukhucululwa kwendle kuthatha ihora elingu-1 ngemuva kokufinyelela ku-80°C. Ukuhlanza kwenziwa njalo ngekota. I-logbook yesistimu yamanzi ahlanzekile iye yahlolwa ngaphandle kohambo olugqanyisiwe.