Asid amino yang dilindungi GLP-1 untuk pengubahsuaian rantai sampingan
Perincian produk
| Tidak. | Produk | CAS No. | Permohonan | Penunjuk Kualiti Utama | ||||
| Kesucian | Isomer | Si * | Maksimum * | Kelembapan | ||||
| 1 | FMOC-LYS (MTT) -OH | 167393-62-6 | Pengubahsuaian rantai sampingan lisin | ≥99.0% | ≤0.1% | ≤0.2% | ≤0.3% | ≤1.0% |
| 2 | FMOC-LYS (Alloc) -OH | 146982-27-6 | Pengubahsuaian rantai sampingan lisin | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤1.0% |
| 3 | FMOC-LYS (IVDDE) -OH | 150629-67-7 | Pengubahsuaian rantai sampingan lisin | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
| 4 | FMOC-LYS (MMT) -OH | 159857-60-0 | Pengubahsuaian rantai sampingan lisin | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
| 5 | FMOC-Glu-Otbu | 84793-07-7 | LiraglutideSemaglutide | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤1.0% |
| 6 | Glu-Otbu | 45120-30-7 | LiraglutideSemaglutide | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤1.0% |
| 7 | Asid octadecanedioic | 871-70-5 | Semaglutide | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 8 | Octadecanedioic acid mono-tert-butil ester | 843666-40-0 | Semaglutide | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 9 | TBU-OOC-C16-CO-GLU-OTBU | 1188328-39-3 | SemaglutideFragmen a | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 10 | Aeea | 134978-97-5 | SemaglutideAlbuvirtide | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 11 | Aeea-oh.hcl | 134979-01-4 | SemaglutideAlbuvirtide | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 12 | FMOC-aeea-oh | 166108-71-0 | SemaglutideAlbuvirtide | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 13 | BOC-aeea-oh | 108466-89-3 | Semaglutide | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 14 | Aeea-aeea | 1143516-05-5 | Semaglutide | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 15 | FMOC-aeea-aeea-oh | 560088-89-3 | SemaglutideFragment b | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 16 | Octa (otbu) -glu (ɑ-otbu) -aeea-aeea-oh | 1118767-16-0 | SemaglutideFragment c | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 17 | TBU-OOC-C16-CO-GLU (AEEA-AEEA-NHS) -OTBU | 1118767-15-9 | SemaglutideFragmen d | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
| 18 | FMOC-LYS (TBU-OOC-C16-CO-GLU (AEEA-AEEA) -OTBU) -OH | 1662688-20-1 | Serpihan semaglutide e | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
| 19 | BOC-HIS (TRT) -OH | 32926-43-5 | Akhir adalah histidin | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤4.0% |
| 20 | FMOC-AIB-OH | 94744-50-0 | Semaglutide | ≥99.5% | / | ≤0.1% | ≤0.2% | ≤1.0% |
| 21 | BOC-HIS (TRT) -AIB-OH | 2061897-68-3 | Semaglutide | ≥99.0% | ≤0.1% | ≤0.2% | ≤0.3% | ≤2.0% |
| 22 | Fmoc-Glu (Otbu) -gly-oh | 866044-63-5 | GLP-1 analog | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
| 23 | BOC-HIS (TRT) -AIB-GLU (OTBU) -GLY-OH | 1169630-31-2？ | Serpihan semaglutide f | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 24 | BOC-HIS (TRT) -AIB-GLU (OTBU) -GLY-NHS | 1169630-40-3 | Serpihan semaglutide g | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
| 25 | FMOC-Arg (PBF) -gly-OH | 660846-80-0 | GLP-1 analog | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
| 26 | FMOC-Ala-Ala-oh | 87512-31-0 | GLP-1 analog | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
| 27 | Fmoc-thr (tbu) -phe-oh | 1260609-75-3? | GLP-1 analog | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
| 28 | Asid palmitik | 1957/10/3 | Fragment Liraglutide 1 | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 29 | Palm-Glu-Otbu | NA | Fragment Liraglutide 2 | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 30 | Palm-Glu (NES) -OTBU | NA | Serpihan Liraglutide 3 | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
| 31 | FMOC-LYS (Palm-Glu-Otbu) -OH | 1491158-62-3 | Liraglutide | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 32 | Asid hexadecanedioic | 505-54-4 | Insulin Degludec | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 33 | Hexadecanedioic Acid Mono-Tert-Butyl Ester | 843666-27-3 | Insulin Degludec | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 34 | TBU-OOC-C14-CO-GLU-OTBU | NA | Serpihan degludec insulin i | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 35 | TBU-OOC-C14-CO-GLU (NES) -OTBU | NA | Insulin Degludec Fragment II | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
Si *= kekotoran tertentu
Max*= maksimum yang tidak diketahui
Penunjuk lain:
- Asid Acetic: ≤0.02% (semua produk)
- Etil asetat: ≤0.5% (semua produk)
- Alkohol: ≤0.5% (semua produk)
Sanitisasi
Sanitisasi sistem pengedaran, termasuk tangki gelung dan penyimpanan dilakukan oleh pasteurisasi. Apabila sanitisasi pasteurisasi dilakukan, air yang disucikan dalam tangki dipanaskan sehingga 80 ° C dan mula beredar oleh sistem pengedaran. Sanitisasi berlangsung selama 1 jam selepas mencapai 80 ° C. Sanitisasi dilakukan setiap suku tahun. Buku log sanitisasi sistem air yang disucikan telah diperiksa tanpa lawatan yang diserlahkan.
