NE. | Produktoj | CAS-numero | Apliko | Ŝlosila Kvalit-Indikilo | ||||
Pureco | Izomero | SI * | Maks. * | Humido | ||||
1 | Fmoc-Lys(Mtt)-OH | 167393-62-6 | Modifo de la flankĉeno de lizino | ≥99.0% | ≤0.1% | ≤0.2% | ≤0.3% | ≤1.0% |
2 | Fmoc-Lys(Alloc)-OH | 146982-27-6 | Modifo de la flankĉeno de lizino | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤1.0% |
3 | Fmoc-Lys(ivDde)-OH | 150629-67-7 | Modifo de la flankĉeno de lizino | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
4 | Fmoc-Lis(Mmt)-OH | 159857-60-0 | Modifo de la flankĉeno de lizino | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
5 | Fmoc-Glu-OtBu | 84793-07-7 | LiraglutidoSemaglutido | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤1.0% |
6 | Glu-OtBu | 45120-30-7 | LiraglutidoSemaglutido | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤1.0% |
7 | Oktadekanodioa acido | 871-70-5 | Semaglutido | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
8 | Oktadekanoia acido mono-tert-butila estero | 843666-40-0 | Semaglutido | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
9 | tBu-OOC-C16-CO-Glu-OtBu | 1188328-39-3 | SemaglutidoFragmento A | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
10 | AEEA | 134978-97-5 | SemaglutidoAlbuvirtido | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
11 | AEEA-OH.HCl | 134979-01-4 | SemaglutidoAlbuvirtido | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
12 | Fmoc-AEEA-OH | 166108-71-0 | SemaglutidoAlbuvirtido | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
13 | Boc-AEEA-OH | 108466-89-3 | Semaglutido | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
14 | AEEA-AEEA | 1143516-05-5 | Semaglutido | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
15 | Fmoc-AEEA-AEEA-OH | 560088-89-3 | SemaglutidoFragmento B | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
16 | Octa(OtBu)-Glu(ɑ-OtBu)-AEEA-AEEA-OH | 1118767-16-0 | SemaglutidoFragmento C | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
17 | tBu-OOC-C16-CO-Glu (AEEA-AEEA-NHS) -OtBu | 1118767-15-9 | SemaglutidoFragmento 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 | Semaglutida Fragmento E | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
19 | Boc-His(Trt)-OH | 32926-43-5 | La fino estas histidino | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤4.0% |
20 | Fmoc-Aib-OH | 94744-50-0 | Semaglutido | ≥99.5% | / | ≤0.1% | ≤0.2% | ≤1.0% |
21 | Boc-His(Trt)-Aib-OH | 2061897-68-3 | Semaglutido | ≥99.0% | ≤0.1% | ≤0.2% | ≤0.3% | ≤2.0% |
22 | Fmoc-Glu(OtBu)-Gly-OH | 866044-63-5 | GLP-1-analogo | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
23 | Boc-His(Trt)-Aib-Glu(OtBu)-Gly-OH | 1169630-31-2? | Semaglutida Fragmento F | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
24 | Boc-His(Trt)-Aib-Glu(OtBu)-Gly-NHS | 1169630-40-3 | Semaglutida Fragmento G | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
25 | Fmoc-Arg(pbf)-Gly-OH | 660846-80-0 | GLP-1-analogo | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
26 | Fmoc-Ala-Ala-OH | 87512-31-0 | GLP-1-analogo | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
27 | Fmoc-Thr(tBu)-Phe-OH | 1260609-75-3 ? | GLP-1-analogo | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
28 | Palmita acido | 1957/10/3 | Liraglutida Fragmento 1 | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
29 | Palmo-Glu-OtBu | NA | Liraglutida Fragmento 2 | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
30 | Palmo-Glu(NES)-OtBu | NA | Liraglutida Fragmento 3 | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
31 | Fmoc-Lys(Palmo-Glu-OtBu)-OH | 1491158-62-3 | Liraglutido | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
32 | Heksadekanedioata acido | 505-54-4 | Insulino degludec | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
33 | Heksadekanedioata acido mono-tert-butila estero | 843666-27-3 | Insulino degludec | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
34 | tBu-OOC-C14-CO-Glu-OtBu | NA | Insulino degludec Fragmento I | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
35 | tBu-OOC-C14-CO-Glu(NES)-OtBu | NA | Insulino degludec Fragmento II | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
SI *= Specifa Malpureco
Maks*= Maks Nekonata Malpuraĵo
Alia Indikilo:
- Aceta acido: ≤0.02% (Ĉiuj produktoj)
- Etila acetato: ≤0.5% (Ĉiuj produktoj)
- Alkoholo: ≤0.5% (Ĉiuj Produktoj)
Steriligo de la distribua sistemo, inkluzive de la buklo kaj la stokujo, estas farata per pasteŭrizado. Kiam oni faras pasteŭrizadon, la purigita akvo en la tanko estas varmigita ĝis 80 °C kaj komencas cirkuli tra la distribua sistemo. La steriligo daŭras 1 horon post atingi 80 °C. Steriligo estas farata ĉiun kvaronjaron. La protokolo pri steriligo de la purigita akvosistemo estis kontrolita, sen elstarigi iun ajn deturnon.