I-Amino Acid evikelwe nge-GLP-1 evikelwe ukuguqulwa kwe-Side Chain Ukuguqulwa
Imininingwane Yomkhiqizo
| Cha. | Imikhiqizo | Case No. | Isicelo | Isikhombi sekhwalithi esemqoka | ||||
| Ubumsulwa | Isikhungo | Si * | UMax * | Ubumanzi | ||||
| 1 | I-FMOC-LYS (MTT) -OH | 167393-62-6 | Ukuguqulwa kwe-Lysine Side Chain Ukuguqulwa | ≥99.0% | ≤0.1% | ≤0.2% | ≤0.3% | ≤1.0% |
| 2 | I-FMOC-LYS (AllOC) -OH | 146982-27-6 | Ukuguqulwa kwe-Lysine Side Chain Ukuguqulwa | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤1.0% |
| 3 | I-FMOC-LYS (IVDDE) -OH | 150629-67-7 | Ukuguqulwa kwe-Lysine Side Chain Ukuguqulwa | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
| 4 | I-FMOC-LYS (MMT) -OH | 159857-60-0 | Ukuguqulwa kwe-Lysine Side Chain Ukuguqulwa | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
| 5 | I-FMOC-Glu-OTBU | 84793-07-7 | LiraglutideSemullutide | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤1.0% |
| 6 | Glu-otbu | 45120-30-7 | LiraglutideSemullutide | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤1.0% |
| 7 | Octadecanedioioc acid | 871-70-5 | Semullutide | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 8 | Octadecanedioioionicialicid mono-tert-butyl ester | 843666-40-0 | Semullutide | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 9 | TBU-OOC-C16-CO-Glu-OTBU | 1188328-39 | SemullutideUcezu a | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 10 | Aleea | 134978-97-5 | SemullutideI-albhamu | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 11 | Aeea-oh.col | 134979-01-4 | SemullutideI-albhamu | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 12 | I-FMOC-AEEA-OH | 166108-71-0 | SemullutideI-albhamu | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 13 | Boc-aeea-oh | 108466-89-3 | Semullutide | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 14 | Aeea-aeea | 1143516-05-5 | Semullutide | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 15 | I-FMOC-AEEA-AEEEA-OH | 560088-89-3 | SemullutideUcezu b | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 16 | Octa (Otbu) -Glu (ɑ-Otbu) -I-AEEA-AH | 1118767-16-0 | SemullutideUcezu c | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 17 | I-TBU-OOC-C16-CO-Glu (AEEEA-AEEAA-NHS) -OTBU | 1118767-15-9 | SemullutideUcezu d | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
| 18 | I-FMOC-LYS (TBU-OOC-C16-CO-Glu (AEEEA-AEEA) -OTBU) -OH | 1662688-20-1 | Semaglutide Ccentcent e | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
| 19 | I-BOC-yakhe (TRT) -OH | 32926-43-5 | Ukuphela kuyinto histdine | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤4.0% |
| 20 | I-FMOC-AIB-OH | 94744-50-0 | Semullutide | ≥99.5% | / | ≤0.1% | ≤0.2% | ≤1.0% |
| 21 | I-BOC-yakhe (TRT) -AIB-OH | 2061897-68-3 | Semullutide | ≥99.0% | ≤0.1% | ≤0.2% | ≤0.3% | ≤2.0% |
| 22 | I-FMOC-Glu (OTBU) -Gly-Oh | I-866044-63-5 | I-FLP-1 Analogue | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
| 23 | I-BOC-yakhe (TRT) -Aib-Glu (OTBU) -Gly-Oh | 11699630-31-2? | Semaglutide Fragment F | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 24 | I-BOC-yakhe (TRT) -Aib-Glu (OTBU) -Gly-NHS | 1169630-40-3 | Semaglutide Ccedle g | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
| 25 | I-FMOC-ALF (PBF) -Gly-Oh | I-660846-80-0 | I-FLP-1 Analogue | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
| 26 | I-FMOC-ALA-ALA-OH | 87512-31-0 | I-FLP-1 Analogue | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
| 27 | I-FMOC-Thry (TBU) -He-Oh | 1260609-75-3? | I-FLP-1 Analogue | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
| 28 | I-Palmitic Acid | 1957/10/3 | Isiqeshana seLiraglutide 1 | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 29 | Palm-glu-otbu | NA | I-Liraglutide Ccentred 2 | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 30 | I-Palm-Glu (NES) -OTBU | NA | I-Liraglutide Ccentred 3 | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
| 31 | I-FMOC-LYS (Palm-Glu-Otbu) -Oh | 1491158-62-3 | Liraglutide | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 32 | I-Hexadecanedioioic acid | 505-54-4 | I-insulin degludec | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 33 | I-Hexadecanedioioionicionicioili acid mono-tert-butyl ester | 843666-27-3 | I-insulin degludec | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 34 | TBU-OOC-C14-CO-Glu-OTBU | NA | I-insulin degludec Preceprec i | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 35 | I-TBU-OOC-C14-CO-Glu (NES) -OTBU | NA | I-insulin degludec Pregrecec II | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
SI * = ukungcola okuthize
Max * = ukungcola okungaziwa
Enye inkomba:
- I-acetic acid: ≤0.02% (yonke imikhiqizo)
- I-Ethyl Acetate: ≤0.5% (yonke imikhiqizo)
- Utshwala: ≤0.5% (yonke imikhiqizo)
Ukuswayilika
Ukuhlanza uhlelo lokusabalalisa, okubandakanya i-loop nethangi lokugcina kwenziwa yi-pasteurization. Lapho kwenziwa i-pasteurization sanitization, amanzi ahlanziwe ethangini afudumele afinyelela ku-80 ° C bese aqala ukujikeleza ngohlelo lokusabalalisa. Ukuhlanza i-Sanitization kuthatha ihora eli-1 ngemuva kokufika kuma-80 ° C. I-Sanitization yenziwa njalo ngekota. Incwadi yokuhlanza i-Lognolbook ehlanziwe ye-Sanitization System yahlolwa ngaphandle kokuqhakanjiswa okugqamile.
