TIDAK. | Produk | CAS No. | Permohonan | Penunjuk Kualiti Utama | ||||
Kesucian | Isomer | SI * | Maks * | lembapan | ||||
1 | Fmoc-Lys(Mtt)-OH | 167393-62-6 | Pengubahsuaian rantai sisi lisin | ≥99.0% | ≤0.1% | ≤0.2% | ≤0.3% | ≤1.0% |
2 | Fmoc-Lys(Alloc)-OH | 146982-27-6 | Pengubahsuaian rantai sisi lisin | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤1.0% |
3 | Fmoc-Lys(ivDde)-OH | 150629-67-7 | Pengubahsuaian rantai sisi lisin | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
4 | Fmoc-Lys(Mmt)-OH | 159857-60-0 | Pengubahsuaian rantai sisi 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 oktadecanedioik | 871-70-5 | Semaglutide | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
8 | Ester mono-tert-butil asid oktadecanedioik | 843666-40-0 | Semaglutide | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
9 | tBu-OOC-C16-CO-Glu-OtBu | 1188328-39-3 | SemaglutideSerpihan 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 | SemaglutideSerpihan B | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
16 | Octa(OtBu)-Glu(ɑ-OtBu)-AEEA-AEEA-OH | 1118767-16-0 | SemaglutideSerpihan C | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
17 | tBu-OOC-C16-CO-Glu(AEEA-AEEA-NHS)-OtBu | 1118767-15-9 | SemaglutideSerpihan 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 | Penghujungnya ialah histidine | ≥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 | Analog GLP-1 | ≥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 | Analog GLP-1 | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
26 | Fmoc-Ala-Ala-OH | 87512-31-0 | Analog GLP-1 | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
27 | Fmoc-Thr(tBu)-Phe-OH | 1260609-75-3 ? | Analog GLP-1 | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
28 | Asid palmitik | 1957/10/3 | Serpihan Liraglutide 1 | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
29 | Palm-Glu-OtBu | NA | Serpihan 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 heksadekanedioik | 505-54-4 | Insulin degludec | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
33 | Ester mono-tert-butil asid heksadekanedioik | 843666-27-3 | Insulin degludec | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
34 | tBu-OOC-C14-CO-Glu-OtBu | NA | Insulin degludec Fragmen I | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
35 | tBu-OOC-C14-CO-Glu(NES)-OtBu | NA | Insulin degludec Fragmen II | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
SI *= Kekotoran Khusus
Maks*= Maks Kekotoran Tidak Diketahui
Penunjuk Lain:
- Asid Acetic: ≤0.02% (Semua Produk)
- Etil Asetat: ≤0.5% (Semua Produk)
- Alkohol: ≤0.5% (Semua Produk)
Pembersihan sistem pengedaran, termasuk gelung dan tangki simpanan dilakukan oleh Pasteurisasi.Apabila sanitasi Pempasteuran dilakukan, air yang telah disucikan dalam tangki dipanaskan sehingga 80°C dan mula beredar melalui sistem pengedaran.Pembasmian berlangsung 1 jam selepas mencapai 80°C.Pembersihan dilakukan setiap suku tahun.Buku log sanitasi sistem air yang telah disucikan telah diperiksa tanpa pengembaraan yang diserlahkan.