GLP-1-skyddad aminosyra för sidokedjemodifiering
Produktdetaljer
| INGA. | Produkt | CAS Nej. | Ansökan | Nyckelkvalitetsindikator | ||||
| Renhet | Isomer | Si * | Max * | Fukt | ||||
| 1 | FMOC-LYS (MTT) -OH | 167393-62-6 | Lysin sidokedjemodifiering | ≥99,0% | ≤0,1% | ≤0,2% | ≤0,3% | ≤1,0% |
| 2 | Fmoc-lys (alloc) -OH | 146982-27-6 | Lysin sidokedjemodifiering | ≥99,5% | ≤0,1% | ≤0,1% | ≤0,2% | ≤1,0% |
| 3 | Fmoc-lys (IVDDE) -OH | 150629-67-7 | Lysin sidokedjemodifiering | ≥98,0% | ≤0,2% | ≤0,3% | ≤0,5% | ≤1,0% |
| 4 | FMOC-LYS (MMT) -OH | 159857-60-0 | Lysin sidokedjemodifiering | ≥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-obbu | 45120-30-7 | LiraglutidSemaglutid | ≥99,5% | ≤0,1% | ≤0,1% | ≤0,2% | ≤1,0% |
| 7 | Oktadekansyra | 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 | Aea | 134978-97-5 | SemaglutidAlbuvirt | ≥99,0% | / | ≤0,2% | ≤0,3% | ≤1,0% |
| 11 | Aeea-oh.hcl | 134979-01-4 | SemaglutidAlbuvirt | ≥99,0% | / | ≤0,2% | ≤0,3% | ≤1,0% |
| 12 | Fmoc-aeea-oh | 166108-71-0 | SemaglutidAlbuvirt | ≥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-aea | 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) -eaa-aea-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 | Slutet är 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 | Palmitinsyra | 1957/10/3 | Liraglutidfragment 1 | ≥99,0% | / | ≤0,2% | ≤0,3% | ≤1,0% |
| 29 | Palm-Glu-Otbu | NA | Liraglutide -fragment 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 | Hexadecansyra | 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 *= specifik föroreningar
Max*= max okänd förorening
Annan indikator:
- Ättiksyra: ≤0,02% (alla produkter)
- Etylacetat: ≤0,5% (alla produkter)
- Alkohol: ≤0,5% (alla produkter)
Sanering
Sanitisering av distributionssystemet, inklusive sling- och lagringstank utförs genom pastörisering. När pasteuriseringssanalisering utförs upphettas det renade vattnet i tanken upp till 80 ° C och börjar cirkulera med distributionssystem. Ranningen varar 1 timme efter att 80 ° C har nått. Sanering utförs varje kvartal. Den renade vattensystemets saneringsloggbok kontrollerades utan utflykt.
