INGEN. | Produkter | CAS nei. | Søknad | Nøkkelkvalitetsindikator | ||||
Renhet | Isomer | Si * | Maks * | Fuktighet | ||||
1 | Fmoc-Lys (MTT) -OH | 167393-62-6 | Lysine sidekjedemodifisering | ≥99,0% | ≤0,1% | ≤0,2% | ≤0,3% | ≤ 1,0% |
2 | Fmoc-Lys (alloc) -OH | 146982-27-6 | Lysine sidekjedemodifisering | ≥99,5% | ≤0,1% | ≤0,1% | ≤0,2% | ≤ 1,0% |
3 | Fmoc-Lys (IVDDE) -OH | 150629-67-7 | Lysine sidekjedemodifisering | ≥98,0% | ≤0,2% | ≤0,3% | ≤0,5% | ≤ 1,0% |
4 | FMOC-Lys (MMT) -OH | 159857-60-0 | Lysine sidekjedemodifisering | ≥98,0% | ≤0,2% | ≤0,3% | ≤0,5% | ≤ 1,0% |
5 | FMOC-GLU-OTBU | 84793-07-7 | LiraglutidSemaglutid | ≥99,5% | ≤0,1% | ≤0,1% | ≤0,2% | ≤ 1,0% |
6 | Glu-Otbu | 45120-30-7 | LiraglutidSemaglutid | ≥99,5% | ≤0,1% | ≤0,1% | ≤0,2% | ≤ 1,0% |
7 | Octadecanedioic acid | 871-70-5 | Semaglutid | ≥99,0% | / | ≤0,2% | ≤0,3% | ≤ 1,0% |
8 | Octadecanedioic acid mono-tert-butyl ester | 843666-40-0 | Semaglutid | ≥99,0% | / | ≤0,2% | ≤0,3% | ≤ 1,0% |
9 | TBU-OOC-C16-Co-GLU-OTBU | 1188328-39-3 | SemaglutidFragment a | ≥98,0% | ≤0,2% | ≤0,5% | ≤0,5% | ≤ 1,0% |
10 | Aeea | 134978-97-5 | SemaglutidAlbuvirtide | ≥99,0% | / | ≤0,2% | ≤0,3% | ≤ 1,0% |
11 | Aeea-oh.hcl | 134979-01-4 | SemaglutidAlbuvirtide | ≥99,0% | / | ≤0,2% | ≤0,3% | ≤ 1,0% |
12 | Fmoc-aeea-oh | 166108-71-0 | SemaglutidAlbuvirtide | ≥99,0% | / | ≤0,2% | ≤0,3% | ≤ 1,0% |
13 | Boc-aeea-oh | 108466-89-3 | Semaglutid | ≥99,0% | / | ≤0,2% | ≤0,3% | ≤ 1,0% |
14 | Aeea-aeeea | 1143516-05-5 | Semaglutid | ≥98,0% | ≤0,2% | ≤0,5% | ≤0,5% | ≤ 1,0% |
15 | Fmoc-aeea-aeea-oh | 560088-89-3 | SemaglutidFragment b | ≥98,0% | ≤0,2% | ≤0,5% | ≤0,5% | ≤ 1,0% |
16 | Octa (otbu) -glu (ɑ-otbu) -aeea-aeeea-oh | 1118767-16-0 | SemaglutidFragment c | ≥98,0% | ≤0,2% | ≤0,5% | ≤0,5% | ≤ 1,0% |
17 | TBU-OOC-C16-Co-GLU (AEEA-AEEA-NHS) -Otbu | 1118767-15-9 | SemaglutidFragment 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 | Semaglutidfragment e | ≥96,0% | ≤0,5% | ≤ 1,0% | ≤ 1,0% | ≤ 1,0% |
19 | Boc-His (TRT) -OH | 32926-43-5 | Slutten er histidin | ≥99,5% | ≤0,1% | ≤0,1% | ≤0,2% | ≤ 4,0% |
20 | FMOC-AIB-OH | 94744-50-0 | Semaglutid | ≥99,5% | / | ≤0,1% | ≤0,2% | ≤ 1,0% |
21 | Boc-His (TRT) -Aib-oh | 2061897-68-3 | Semaglutid | ≥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? | Semaglutidfragment f | ≥98,0% | ≤0,2% | ≤0,5% | ≤0,5% | ≤ 1,0% |
24 | Boc-His (TRT) -AIB-GLU (OTBU) -GLY-NHS | 1169630-40-3 | Semaglutidfragment 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 | Palmitinsyre | 1957/10/3 | Liraglutidfragment 1 | ≥99,0% | / | ≤0,2% | ≤0,3% | ≤ 1,0% |
29 | Palm-Glu-Otbu | NA | Liraglutidfragment 2 | ≥98,0% | ≤0,2% | ≤0,5% | ≤0,5% | ≤ 1,0% |
30 | Palm-Glu (NES) -Otbu | NA | Liraglutidfragment 3 | ≥96,0% | ≤0,5% | ≤ 1,0% | ≤ 1,0% | ≤ 1,0% |
31 | FMOC-Lys (Palm-Glu-Otbu) -OH | 1491158-62-3 | Liraglutid | ≥98,0% | ≤0,2% | ≤0,5% | ≤0,5% | ≤ 1,0% |
32 | Heksadekanediosyre | 505-54-4 | Insulin degludec | ≥99,0% | / | ≤0,2% | ≤0,3% | ≤ 1,0% |
33 | Hexadecanedioic acid mono-tert-butylester | 843666-27-3 | Insulin degludec | ≥99,0% | / | ≤0,2% | ≤0,3% | ≤ 1,0% |
34 | TBU-OOC-C14-Co-GLU-OTBU | NA | Insulin degludec fragment 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 *= spesifikk urenhet
Maks*= maks ukjent urenhet
Annen indikator:
- eddiksyre: ≤0,02% (alle produkter)
- Etylacetat: ≤0,5% (alle produkter)
- Alkohol: ≤0,5% (alle produkter)
Sanering av distribusjonssystem, inkludert sløyfe og lagringstank utføres ved pasteurisering. Når sanering av pasteurisering utføres, varmes det rensede vannet i tank opp til 80 ° C og begynner å sirkulere etter distribusjonssystem. Sanering varer 1 time etter å ha nådd 80 ° C. Sanering utføres hvert kvartal. Den rensede loggboken for rensesystemet ble sjekket uten uthevet utflukt.