GLP-1 Amino Acid Protetti għall-Modifikazzjoni tal-Katina tal-Ġnub
Dettall tal-Prodott
| LE. | Prodotti | CAS Nru. | Applikazzjoni | Indikatur Ewlenin tal-Kwalità | ||||
| Purità | Isomeru | SI * | Max * | Umdità | ||||
| 1 | Fmoc-Lys(Mtt)-OH | 167393-62-6 | Modifikazzjoni tal-katina tal-ġenb tal-lysine | ≥99.0% | ≤0.1% | ≤0.2% | ≤0.3% | ≤1.0% |
| 2 | Fmoc-Lys(Alloc)-OH | 146982-27-6 | Modifikazzjoni tal-katina tal-ġenb tal-lysine | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤1.0% |
| 3 | Fmoc-Lys(ivDde)-OH | 150629-67-7 | Modifikazzjoni tal-katina tal-ġenb tal-lysine | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
| 4 | Fmoc-Lys(Mmt)-OH | 159857-60-0 | Modifikazzjoni tal-katina tal-ġenb tal-lysine | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
| 5 | Fmoc-Glu-OtBu | 84793-07-7 | LiraglutideSemaglutide | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤1.0% |
| 6 | Glu-OtBu | 45120-30-7 | LiraglutideSemaglutide | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤1.0% |
| 7 | Aċidu Octadecanedioic | 871-70-5 | Semaglutide | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 8 | Ester mono-tert-butil tal-aċidu octadecanedioic | 843666-40-0 | Semaglutide | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 9 | tBu-OOC-C16-CO-Glu-OtBu | 1188328-39-3 | SemaglutideFramment A | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 10 | AEEA | 134978-97-5 | SemaglutideAlbuvirtide | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 11 | AEEA-OH.HCl | 134979-01-4 | SemaglutideAlbuvirtide | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 12 | Fmoc-AEEA-OH | 166108-71-0 | SemaglutideAlbuvirtide | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 13 | Boc-AEEA-OH | 108466-89-3 | Semaglutide | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 14 | AEEA-AEEA | 1143516-05-5 | Semaglutide | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 15 | Fmoc-AEEA-AEEA-OH | 560088-89-3 | SemaglutideFramment B | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 16 | Octa(OtBu)-Glu(ɑ-OtBu)-AEEA-AEEA-OH | 1118767-16-0 | SemaglutideFramment Ċ | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 17 | tBu-OOC-C16-CO-Glu(AEEA-AEEA-NHS)-OtBu | 1118767-15-9 | SemaglutideFramment 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 | Semaglutide Fragment E | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
| 19 | Boc-His(Trt)-OH | 32926-43-5 | It-tmiem huwa l-istidina | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤4.0% |
| 20 | Fmoc-Aib-OH | 94744-50-0 | Semaglutide | ≥99.5% | / | ≤0.1% | ≤0.2% | ≤1.0% |
| 21 | Boc-His(Trt)-Aib-OH | 2061897-68-3 | Semaglutide | ≥99.0% | ≤0.1% | ≤0.2% | ≤0.3% | ≤2.0% |
| 22 | Fmoc-Glu(OtBu)-Gly-OH | 866044-63-5 | GLP-1 analogu | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
| 23 | Boc-His(Trt)-Aib-Glu(OtBu)-Gly-OH | 1169630-31-2? | Semaglutide Framment F | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 24 | Boc-His(Trt)-Aib-Glu(OtBu)-Gly-NHS | 1169630-40-3 | Semaglutide Framment G | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
| 25 | Fmoc-Arg(pbf)-Gly-OH | 660846-80-0 | GLP-1 analogu | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
| 26 | Fmoc-Ala-Ala-OH | 87512-31-0 | GLP-1 analogu | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
| 27 | Fmoc-Thr(tBu)-Phe-OH | 1260609-75-3 ? | GLP-1 analogu | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
| 28 | Aċidu palmitiku | 1957/10/3 | Liraglutide Framment 1 | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 29 | Palm-Glu-OtBu | NA | Liraglutide Framment 2 | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 30 | Palm-Glu(NES)-OtBu | NA | Liraglutide Framment 3 | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
| 31 | Fmoc-Lys(Palm-Glu-OtBu)-OH | 1491158-62-3 | Liraglutide | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 32 | Aċidu hexadecanedioic | 505-54-4 | Insulina degludec | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 33 | Ester mono-tert-butil tal-aċidu hexadecanedioic | 843666-27-3 | Insulina degludec | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 34 | tBu-OOC-C14-CO-Glu-OtBu | NA | Insulina degludec Framment I | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 35 | tBu-OOC-C14-CO-Glu(NES)-OtBu | NA | Insulina degludec Framment II | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
SI *= Impurità Speċifika
Max*= Max Mhux Magħruf Impurità
Indikatur ieħor:
- Aċidu Aċetiku: ≤0.02% (Il-Prodotti Kollha)
- Ethyl Acetate: ≤0.5% (Il-Prodotti Kollha)
- Alkoħol: ≤0.5% (Il-Prodotti Kollha)
Sanitizzazzjoni
Is-sanitizzazzjoni tas-sistema tad-distribuzzjoni, inkluż il-linja u t-tank tal-ħażna titwettaq permezz tal-Pasturizzazzjoni.Meta titwettaq sanitizzazzjoni tal-Pasturizzazzjoni, l-ilma purifikat fit-tank jissaħħan sa 80 ° C u jibda jiċċirkola b'sistema ta 'distribuzzjoni.Is-sanitizzazzjoni ddum siegħa wara li tilħaq it-80°C.Is-sanitizzazzjoni ssir kull tliet xhur.Il-ġurnal ta' abbord tas-sanitizzazzjoni tas-sistema tal-ilma purifikat ġie ċċekkjat mingħajr ebda eskursjoni enfasizzata.
