GLP-1 beskyttet aminosyre til modifikation af sidekæde
Produktdetaljer
| INGEN. | Produkter | CAS Nej. | Anvendelse | Indikator for nøglekvalitet | ||||
| Renhed | Isomer | Si * | Max * | Fugtighed | ||||
| 1 | Fmoc-lys (MTT) -OH | 167393-62-6 | Lysin -sidekædemodifikation | ≥99,0% | ≤0,1% | ≤0,2% | ≤0,3% | ≤1,0% |
| 2 | Fmoc-lys (alloc) -OH | 146982-27-6 | Lysin -sidekædemodifikation | ≥99,5% | ≤0,1% | ≤0,1% | ≤0,2% | ≤1,0% |
| 3 | Fmoc-Lys (IVDDE) -OH | 150629-67-7 | Lysin -sidekædemodifikation | ≥98,0% | ≤0,2% | ≤0,3% | ≤0,5% | ≤1,0% |
| 4 | Fmoc-Lys (MMT) -OH | 159857-60-0 | Lysin -sidekædemodifikation | ≥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 | Octadecanedioinsyre | 871-70-5 | Semaglutid | ≥99,0% | / | ≤0,2% | ≤0,3% | ≤1,0% |
| 8 | Octadecanedioic acid 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 | Enden 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 | Hexadecanedioinsyre | 505-54-4 | Insulin degludec | ≥99,0% | / | ≤0,2% | ≤0,3% | ≤1,0% |
| 33 | Hexadecanedioinsyre 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 urenhed
Max*= maks. Ukendt urenhed
Anden indikator:
- eddikesyre: ≤0,02% (alle produkter)
- Ethylacetat: ≤0,5% (alle produkter)
- Alkohol: ≤0,5% (alle produkter)
Sanitisering
Sanitisering af distributionssystemet, herunder sløjfe og opbevaringstank, udføres ved pasteurisering. Når pasteuriseringssanitering udføres, opvarmes det oprensede vand i tank op til 80 ° C og begynder at cirkulere med distributionssystem. Sanitiseringen varer 1 time efter at have nået 80 ° C. Sanitisering udføres hvert kvartal. Den oprensede vandsystem -sanitiseringslogbog blev kontrolleret uden fremhævet udflugt.
