| NO | Cynhyrchion | Rhif CAS | Cais | Dangosydd Ansawdd Allweddol | ||||
| Purdeb | Isomer | Amhuredd penodol | *Uchafswm o 1 | Lleithder | ||||
| 1 | Fmoc-3-(2-naffthyl)-D-Ala-OH | 138774-94-4 | Y rhan fwyaf o gynhyrchion | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 2 | Ac-3-(2-naffthyl)-D-Ala-OH | 37440-01-0 | Y rhan fwyaf o gynhyrchion | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 3 | Fmoc-3-(3-pyridinyl)-D-Ala-OH | 142994-45-4 | Y rhan fwyaf o gynhyrchion | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 4 | Fmoc-4-chloro-D-Phe-OH | 142994-19-2 | Y rhan fwyaf o gynhyrchion | ≥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 | Y rhan fwyaf o gynhyrchion | ≥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 | Antide | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
| 16 | Fmoc-D-Lys(nicotinoyl)-OH | 252049-12-0 | Antide | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
* Max1 = Uchafswm Amhuredd Anhysbys
Dangosydd Arall:
- Asid Asetig: ≤0.02% (Pob Cynnyrch)
- Ethyl Acetate: ≤0.5% (Pob Cynnyrch)
- Alcohol: ≤0.5% (Pob Cynnyrch)
Mae TOC a dargludedd y prif bwyntiau cyflenwi a dychwelyd yn cael eu monitro'n rheolaidd. Mae TOC yn cael ei fonitro gan QC bob wythnos. Mae dargludedd yn cael ei fonitro ar-lein a'i gofnodi gan weithredwr gorsaf dŵr wedi'i buro unwaith bob pedair awr. Mae'r dargludedd yn cael ei fonitro yn y prif RO, yr eilaidd RO, yr EDI a phwynt dychwelyd cyflawn y system ddosbarthu. Mae manyleb y dŵr wedi'i buro ar waith ac yn cydymffurfio â manyleb wedi'i diffinio ymlaen llaw nad yw'n fwy nag 1.3 µs/cm ar 25°C (USP). Ar gyfer prif bwyntiau cyflenwi a dychwelyd, cynhelir prawf llawn bob wythnos, ar gyfer pwynt defnyddio arall yn y ddolen gylchredeg, cynhelir prawf llawn unwaith bob mis. Mae'r prawf llawn yn cynnwys nodweddion, pH, nitrad, nitraid, amonia, dargludedd, TOC, sylweddau anweddol, metelau trwm, terfynau microbaidd ac endotocsin bacteriol.