TIDAK. | Produk | CAS No. | Aplikasi | Indikator kualitas utama | ||||
Kemurnian | Isomer | Si * | Max * | Kelembaban | ||||
1 | FMOC-LYS (MTT) -OH | 167393-62-6 | Modifikasi rantai samping lisin | ≥99.0% | ≤0,1% | ≤0,2% | ≤0,3% | ≤1.0% |
2 | Fmoc-lys (alloc) -oh | 146982-27-6 | Modifikasi rantai samping lisin | ≥99,5% | ≤0,1% | ≤0,1% | ≤0,2% | ≤1.0% |
3 | FMOC-LYS (IVDDE) -OH | 150629-67-7 | Modifikasi rantai samping lisin | ≥98,0% | ≤0,2% | ≤0,3% | ≤0,5% | ≤1.0% |
4 | FMOC-LYS (MMT) -OH | 159857-60-0 | Modifikasi rantai samping 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 | Asam octadecanedioic | 871-70-5 | Semaglutide | ≥99.0% | / | ≤0,2% | ≤0,3% | ≤1.0% |
8 | Octadecanedioic acid mono-ter-butyl 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 | SemaglutideFragmen b | ≥98,0% | ≤0,2% | ≤0,5% | ≤0,5% | ≤1.0% |
16 | Octa (otbu) -glu (ɑ-otbu) -aeea-aeea-oh | 1118767-16-0 | SemaglutideFragmen 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 | Fragmen semaglutide e | ≥96,0% | ≤0,5% | ≤1.0% | ≤1.0% | ≤1.0% |
19 | BOC-HIS (TRT) -OH | 32926-43-5 | Akhirnya 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 | 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? | Fragmen semaglutide f | ≥98,0% | ≤0,2% | ≤0,5% | ≤0,5% | ≤1.0% |
24 | BOC-HIS (TRT) -aib-glu (otbu) -gly-nhs | 1169630-40-3 | Fragmen 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 | Asam palmitat | 1957/10/3 | Fragmen liraglutide 1 | ≥99.0% | / | ≤0,2% | ≤0,3% | ≤1.0% |
29 | Palm-Glu-Otbu | NA | Fragmen Liraglutide 2 | ≥98,0% | ≤0,2% | ≤0,5% | ≤0,5% | ≤1.0% |
30 | Palm-Glu (NES) -OtBU | NA | Fragmen 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 | Asam Hexadecanedioic | 505-54-4 | Insulin Degludec | ≥99.0% | / | ≤0,2% | ≤0,3% | ≤1.0% |
33 | Ester asam heksadecanedioic mono-ter-butil | 843666-27-3 | Insulin Degludec | ≥99.0% | / | ≤0,2% | ≤0,3% | ≤1.0% |
34 | TBU-OOC-C14-CO-GLU-OTBU | NA | Fragmen insulin degludec 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 *= pengotor spesifik
Max*= Max yang tidak diketahui pengotor
Indikator lain:
- Asam asetat: ≤0,02% (semua produk)
- etil asetat: ≤0,5% (semua produk)
- Alkohol: ≤0,5% (semua produk)
Sanitasi sistem distribusi, termasuk loop dan tangki penyimpanan dilakukan dengan pasteurisasi. Ketika sanitasi pasteurisasi dilakukan, air yang dimurnikan dalam tangki dipanaskan hingga 80 ° C dan mulai bersirkulasi dengan sistem distribusi. Sanitasi berlangsung 1 jam setelah mencapai 80 ° C. Sanitasi dilakukan setiap kuartal. Buku log sanitasi sistem air yang dimurnikan diperiksa tanpa tamasya yang disorot.