| NO | Producta | Numerus CAS | Applicatio | Indicator Qualitatis Clavis | ||||
| Puritas | Isomerus | Impuritas specifica | *Max1 | Humiditas | ||||
| 1 | Fmoc-3-(2-naphthyl)-D-Ala-OH | 138774-94-4 | Plurima producta | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 2 | Ac-3-(2-naphthyl)-D-Ala-OH | 37440-01-0 | Plurima producta | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 3 | Fmoc-3-(3-pyridinyl)-D-Ala-OH | 142994-45-4 | Plurima producta | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 4 | Fmoc-4-chloro-D-Phe-OH | 142994-19-2 | Plurima producta | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 5 | Fmoc-D-Cit-OH | 200344-33-8 | Cetrorelix | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤1.0% |
| 6 | Fmoc-D-Ala-OH.H2O | 79990-15-1 | Plurima producta | ≥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(nicotinoyl)-OH | 252049-11-9 | Antida | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
| 16 | Fmoc-D-Lys(nicotinoyl)-OH | 252049-12-0 | Antida | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
* Max1 = Maxima Impuritas Ignota
Aliud Indicem:
- Acidum Aceticum: ≤0.02% (Omnia Producta)
- Acetas Aethylicus: ≤0.5% (Omnia Producta)
- Alcohol: ≤0.5% (Omnia Producta)
TOC et conductivitas punctorum principalium immissionis et reditus periodicē monitorantur. TOC per QC (Quantitatem Qualitatis) singulis hebdomadibus monitoratur. Conductivitas interretialis monitoratur et ab operatore stationis aquae purificatae semel singulis quattuor horis notatur. Conductivitas in RO primario, RO secundario, EDI (Electronica Distributionis), et puncto reditus totalis systematis distributionis monitoratur. Specificatio aquae purificatae instituta est et specificationi praedefinitae congruit, quae non plus quam 1.3 µs/cm ad 25°C (USP). Pro punctis principalibus immissionis et reditus, probatio plena singulis hebdomadibus perficitur, pro aliis punctis usui in circuitu circulante, probatio plena semel in mense perficitur. Probatio plena characteres, pH, nitratum, nitritum, ammoniacum, conductivitatem, TOC, substantias non volatiles, metalla gravia, limites microbiales, et endotoxinum bacteriale comprehendit.