| NO | Prodotti | Numru CAS | Applikazzjoni | Indikatur Ewlieni tal-Kwalità | ||||
| Purità | Iżomeru | Impurità speċifika | *Massimu1 | Umdità | ||||
| 1 | Fmoc-3-(2-naftil)-D-Ala-OH | 138774-94-4 | Il-biċċa l-kbira tal-prodotti | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 2 | Ac-3-(2-naftil)-D-Ala-OH | 37440-01-0 | Il-biċċa l-kbira tal-prodotti | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 3 | Fmoc-3-(3-piridinil)-D-Ala-OH | 142994-45-4 | Il-biċċa l-kbira tal-prodotti | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 4 | Fmoc-4-kloro-D-Phe-OH | 142994-19-2 | Il-biċċa l-kbira tal-prodotti | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 5 | Fmoc-D-Cit-OH | 200344-33-8 | Ċetrorelix | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤1.0% |
| 6 | Fmoc-D-Ala-OH.H2O | 79990-15-1 | Il-biċċa l-kbira tal-prodotti | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤6.5% |
| 7 | Fmoc-D-Aph(tBuCbm)-OH | 1433975-21-3 | Degarelix | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 8 | Fmoc-D-Aph(Cbm)-OH | 324017-22-3 | Degarelix | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 9 | Fmoc-L-Aph(L-Hor)-OH | 1253282-31-3 | Degarelix | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 10 | Fmoc-L-Lys(iPr,Boc)-OH | 201003-48-7 | Degarelix | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 11 | Fmoc-N-Me-Tyr(tBu)-OH | 133373-24-7 | Abarelix | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 12 | Fmoc-D-Asn(Trt)-OH | 180570-71-2 | Abarelix | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 13 | Fmoc-HomoArg(Et)2-OH.HCl | 1864003-26-8 | Ganirelix | ≥95.0% | ≤0.5% | ≤1.0% | ≤2.0% | ≤2.0% |
| 14 | Fmoc-D-HomoArg(Et)2-OH.HCl | 2098497-24-4 | Ganirelix | ≥95.0% | ≤0.5% | ≤1.0% | ≤2.0% | ≤2.0% |
| 15 | Fmoc-Lys(nikotinojl)-OH | 252049-11-9 | Antide | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
| 16 | Fmoc-D-Lys(nikotinojl)-OH | 252049-12-0 | Antide | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
* Max1 = 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)
It-TOC u l-konduttività tal-punti ewlenin tal-provvista u tar-ritorn huma mmonitorjati perjodikament. It-TOC huwa mmonitorjat permezz tal-QC kull ġimgħa. Il-konduttività hija mmonitorjata online u rreġistrata mill-operatur tal-istazzjon tal-ilma ppurifikat darba kull erba' sigħat. Il-konduttività hija mmonitorjata fl-RO primarju, RO sekondarju, EDI u l-punt ta' ritorn totali tas-sistema ta' distribuzzjoni. L-ispeċifikazzjoni tal-ilma ppurifikat hija fis-seħħ u tikkonforma mal-ispeċifikazzjoni predefinita li mhux aktar minn 1.3 µs/cm f'25°C (USP). Għall-punti ewlenin tal-provvista u tar-ritorn, test sħiħ jitwettaq kull ġimgħa, għal punti oħra ta' użu fil-linja taċ-ċirkolazzjoni, test sħiħ jitwettaq darba fix-xahar. It-test sħiħ jinkludi karattri, pH, nitrat, nitrit, ammonja, konduttività, TOC, sustanzi mhux volatili, metalli tqal, limiti mikrobjali u endotossina batterjali.