Aċidu Aminiku Protett bil-GLP-1 għall-Modifikazzjoni tal-Katina tal-Ġenb
Dettalji tal-Prodott
| LE. | Prodotti | Numru CAS | Applikazzjoni | Indikatur Ewlieni tal-Kwalità | ||||
| Purità | Iżomeru | SI * | Massimu * | Umdità | ||||
| 1 | Fmoc-Lys(Mtt)-OH | 167393-62-6 | Modifikazzjoni tal-katina tal-ġenb tal-lisina | ≥99.0% | ≤0.1% | ≤0.2% | ≤0.3% | ≤1.0% |
| 2 | Fmoc-Lys(Alloc)-OH | 146982-27-6 | Modifikazzjoni tal-katina tal-ġenb tal-lisina | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤1.0% |
| 3 | Fmoc-Lys(ivDde)-OH | 150629-67-7 | Modifikazzjoni tal-katina tal-ġenb tal-lisina | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
| 4 | Fmoc-Lys(Mmt)-OH | 159857-60-0 | Modifikazzjoni tal-katina tal-ġenb tal-lisina | ≥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 ottadekanedojku | 871-70-5 | Semaglutide | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 8 | Ester mono-tert-butil tal-aċidu ottadekanedojku | 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 | L-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 | Framment E tas-Semaglutide | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
| 19 | Boc-His(Trt)-OH | 32926-43-5 | It-tarf 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 | Analogu tal-GLP-1 | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
| 23 | Boc-His(Trt)-Aib-Glu(OtBu)-Gly-OH | 1169630-31-2? | Framment F tas-Semaglutide | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 24 | Boc-His(Trt)-Aib-Glu(OtBu)-Gly-NHS | 1169630-40-3 | Framment tas-Semaglutide G | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
| 25 | Fmoc-Arg(pbf)-Gly-OH | 660846-80-0 | Analogu tal-GLP-1 | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
| 26 | Fmoc-Ala-Ala-OH | 87512-31-0 | Analogu tal-GLP-1 | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
| 27 | Fmoc-Thr(tBu)-Phe-OH | 1260609-75-3? | Analogu tal-GLP-1 | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
| 28 | Aċidu palmitiku | 1957/10/3 | Framment ta' Liraglutide 1 | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 29 | Palm-Glu-OtBu | NA | Framment ta' Liraglutide 2 | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 30 | Palm-Glu(NES)-OtBu | NA | Framment ta' Liraglutide 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 eżadekanedojku | 505-54-4 | Insulina degludec | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 33 | Ester mono-tert-butil tal-aċidu eżadekanedojku | 843666-27-3 | Insulina degludec | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 34 | tBu-OOC-C14-CO-Glu-OtBu | NA | Framment I tal-insulina degludec | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 35 | tBu-OOC-C14-CO-Glu(NES)-OtBu | NA | Framment II tal-insulina degludec | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
SI *= Impurità Speċifika
Max*= Impurità Massima Mhux Magħrufa
Indikatur Ieħor:
- Aċidu Aċetiku: ≤0.02% (Il-Prodotti Kollha)
- Aċetat tal-Etil: ≤0.5% (Il-Prodotti Kollha)
- Alkoħol: ≤0.5% (Il-Prodotti Kollha)
Sanitizzazzjoni
Is-sanitizzazzjoni tas-sistema ta' distribuzzjoni, inkluż il-linja u t-tank tal-ħażna, titwettaq permezz tal-Pasturizzazzjoni. Meta titwettaq is-sanitizzazzjoni bil-Pasturizzazzjoni, l-ilma ppurifikat fit-tank jissaħħan sa 80°C u jibda jiċċirkola mis-sistema ta' distribuzzjoni. Is-sanitizzazzjoni ddum siegħa wara li tilħaq it-80°C. Is-sanitizzazzjoni titwettaq kull tliet xhur. Il-ktieb tar-reġistrazzjoni tas-sanitizzazzjoni tas-sistema tal-ilma ppurifikat ġie ċċekkjat mingħajr ma ġie enfasizzat li kien hemm xi eskursjoni.
