LE. | Prodotti | CAS Nru. | Applikazzjoni | Indikatur tal-kwalità ewlieni | ||||
Purità | Isomer | Si * | Max * | Umdità | ||||
1 | Fmoc-lys (mtt) -OH | 167393-62-6 | Modifika tal-katina tal-ġenb tal-lysine | ≥99.0% | ≤0.1% | ≤0.2% | ≤0.3% | ≤1.0% |
2 | Fmoc-lys (alloc) -OH | 146982-27-6 | Modifika tal-katina tal-ġenb tal-lysine | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤1.0% |
3 | FMOC-Lys (IVDDE) -OH | 150629-67-7 | Modifika tal-katina tal-ġenb tal-lysine | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
4 | FMOC-Lys (MMT) -OH | 159857-60-0 | Modifika 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 | Aċidu Octadecanedioic Mono-tert-butyl ester | 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 c | ≥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 ta 'Semaglutide e | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
19 | BOC-HIS (TRT) -OH | 32926-43-5 | It-tmiem huwa 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 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 ta 'semaglutide f | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
24 | BOC-HIS (TRT) -AIB-GLU (OTBU) -Gly-NHS | 1169630-40-3 | Framment ta 'Semaglutide g | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
25 | FMOC-Arg (PBF) -Gly-OH | 660846-80-0 | Analogu GLP-1 | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
26 | Fmoc-ala-ala-oh | 87512-31-0 | Analogu GLP-1 | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
27 | FMOC-Thr (TBU) -Phe-OH | 1260609-75-3? | Analogu GLP-1 | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
28 | Aċidu palmitiku | 1957/10/3 | Framment Liraglutide 1 | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
29 | Palm-Glu-Otbu | NA | Framment Liraglutide 2 | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
30 | Palm-Glu (NES) -otbu | NA | Framment 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 hexadecanedioic | 505-54-4 | Insulina DeGludec | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
33 | Ester mono-tert-butyl acid hexadecanedioic | 843666-27-3 | Insulina DeGludec | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
34 | TBU-OOC-C14-Co-Glu-OTBU | NA | Framment ta 'l-insulina degludec i | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
35 | TBU-OOC-C14-Co-Glu (NES) -otBU | NA | Fragment ta 'l-insulina deGludec II | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
Si * = impurità speċifika
Max * = max impurità 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 tas-sistema ta 'distribuzzjoni, inkluż loop u tank tal-ħażna titwettaq permezz ta' pasturizzazzjoni. Meta titwettaq sanitizzazzjoni tal-pasturizzazzjoni, l-ilma ppurifikat fit-tank jissaħħan sa 80 ° C u jibda jiċċirkola permezz tas-sistema ta 'distribuzzjoni. Is-sanitizzazzjoni ddum siegħa wara li laħqet it-80 ° C. Is-sanitizzazzjoni ssir kull tliet xhur. Il-ġurnal ta ’sanitizzazzjoni tas-sistema tal-ilma ppurifikat ġie kkontrollat bl-ebda eskursjoni enfasizzata.