| NO | Iimveliso | Inombolo yeCAS. | Isicelo | Isalathisi soMgangatho oPhambili | ||||
| Ubunyulu | Isomer | Ukungcola okuthe ngqo | *Ubukhulu 1 | Ukufuma | ||||
| 1 | Fmoc-3-(2-naphthyl)-D-Ala-OH | 138774-94-4 | Uninzi lweemveliso | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 2 | I-Ac-3-(2-naphthyl)-D-Ala-OH | 37440-01-0 | Uninzi lweemveliso | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 3 | Fmoc-3-(3-pyridinyl)-D-Ala-OH | 142994-45-4 | Uninzi lweemveliso | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 4 | Fmoc-4-chloro-D-Phe-OH | 142994-19-2 | Uninzi lweemveliso | ≥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 | Uninzi lweemveliso | ≥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 | I-Fmoc-Lys(nicotinoyl)-OH | 252049-11-9 | Antide | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
| 16 | I-Fmoc-D-Lys(nicotinoyl)-OH | 252049-12-0 | Antide | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
* UMax1 = Ubuninzi bokungacoceki okungaziwayo
Esinye isalathisi:
-Acetic Acid: ≤0.02% (Zonke iimveliso)
-Ethyl Acetate: ≤0.5% (Zonke Iimveliso)
- Utywala: ≤0.5% (Zonke Iimveliso)
I-TOC kunye ne-conductivity yobonelelo oluphambili kunye neendawo zokubuya zibekwe esweni ngamaxesha athile. I-TOC ibekwe esweni yi-QC veki nganye. I-Conductivity ijongwa kwi-intanethi kwaye irekhodwa ngumsebenzisi wesikhululo samanzi acociweyo kanye ngeyure ezine. I-conductivity ibekwe esweni kwi-RO ephambili, i-RO yesibini, i-EDI kunye ne-total return point of distribution system. Iinkcukacha zamanzi acociweyo zikhona kwaye zihambelana neenkcukacha ezichazwe kwangaphambili ezingadluli kwi-1.3 µs/cm kuma-25°C (USP). Kubonelelo oluphambili kunye namanqaku okubuyisela, uvavanyo olupheleleyo. lwenziwa veki nganye, kwezinye iindawo zokusebenzisa kwi-loop ejikelezayo, uvavanyo olupheleleyo lwenziwa kanye ngenyanga. Uvavanyo olupheleleyo lubandakanya abalinganiswa, i-pH, i-nitrate, i-nitrite, i-ammonia, i-conductivity, i-TOC, izinto ezingaguqukiyo, isinyithi esinzima, imida ye-microbial kunye ne-endotoxin yebhaktheriya.