NO. | Produk | Nomer CAS | Aplikasi | Indikator Kualitas Utama | ||||
kemurnian | Isomer | SI* | Maks * | Kelembapan | ||||
1 | Fmoc-Lys(Mtt)-OH | 167393-62-6 | modifikasi rantai sisih Lysine | ≥99,0% | ≤0,1% | ≤0,2% | ≤0,3% | ≤1,0% |
2 | Fmoc-Lys(Alloc)-OH | 146982-27-6 | modifikasi rantai sisih Lysine | ≥99,5% | ≤0,1% | ≤0,1% | ≤0,2% | ≤1,0% |
3 | Fmoc-Lys(ivDde)-OH | 150629-67-7 | modifikasi rantai sisih Lysine | ≥98,0% | ≤0,2% | ≤0,3% | ≤0,5% | ≤1,0% |
4 | Fmoc-Lys(Mmt)-OH | 159857-60-0 | modifikasi rantai sisih Lysine | ≥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 | Asam Octadecanedioic 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 | 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 | SemaglutidePecahan 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 | Pungkasane yaiku 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? | 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 heksadekanedioat | 505-54-4 | Insulin degludec | ≥99,0% | / | ≤0,2% | ≤0,3% | ≤1,0% |
33 | Asam heksadekanedioat mono-tert-butil ester | 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 * = Pengotor Spesifik
Maks* = Maks Kotor sing ora dingerteni
Indikator liyane:
- Asam asetat: ≤0,02% (Kabeh Produk)
- Etil Asetat: ≤0,5% (Kabeh Produk)
- Alkohol: ≤0,5% (Kabeh Produk)
Sanitasi sistem distribusi, kalebu loop lan tangki panyimpenan ditindakake kanthi Pasteurisasi.Nalika sanitasi Pasteurisasi ditindakake, banyu sing wis diresiki ing tangki dipanasake nganti 80 ° C lan wiwit sirkulasi kanthi sistem distribusi.Sanitisasi tahan 1 jam sawise tekan 80 ° C.Sanitisasi ditindakake saben kuartal.Buku log sanitasi sistem banyu sing wis diresiki dicenthang tanpa disorot.