GLP-1-skyddad aminosyra för modifiering av sidokedjor
Produktdetalj
| NEJ. | Produkter | CAS-nr. | 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-OtBu | 45120-30-7 | LiraglutidSemaglutid | ≥99,5 % | ≤0,1 % | ≤0,1 % | ≤0,2 % | ≤1,0 % |
| 7 | Oktadekandisyra | 871-70-5 | Semaglutid | ≥99,0 % | / | ≤0,2 % | ≤0,3 % | ≤1,0 % |
| 8 | Oktadekandisyra mono-tert-butylester | 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-AEEA | 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-AEEA-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 | 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 | Hexadekandisyra | 505-54-4 | Insulin degludec | ≥99,0 % | / | ≤0,2 % | ≤0,3 % | ≤1,0 % |
| 33 | Hexadekandisyra 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 förorening
Max*= Max Okänd förorening
Annan indikator:
- Ättiksyra: ≤0,02 % (alla produkter)
- Etylacetat: ≤0,5 % (alla produkter)
- Alkohol: ≤0,5 % (alla produkter)
Sanering
Sanering av distributionssystem, inklusive slinga och lagringstank utförs av pastörisering.När pastöriseringssanering utförs värms det renade vattnet i tanken upp till 80°C och börjar cirkulera i distributionssystemet.Saneringen varar 1 timme efter att ha uppnått 80°C.Sanering utförs varje kvartal.Loggboken för sanering av det renade vattensystemet kontrollerades utan att någon utflykt markerats.
