| NO | Nā huahana | CAS No. | Palapala noi | Hōʻike Koʻikoʻi Kiʻi | ||||
| Maemae | Isomer | haumia kikoʻī | *Max1 | Māmā | ||||
| 1 | Fmoc-3-(2-naphthyl)-D-Ala-OH | 138774-94-4 | ʻO ka hapa nui o nā huahana | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 2 | Ac-3-(2-naphthyl)-D-Ala-OH | 37440-01-0 | ʻO ka hapa nui o nā huahana | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 3 | Fmoc-3-(3-pyridinyl)-D-Ala-OH | 142994-45-4 | ʻO ka hapa nui o nā huahana | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 4 | Fmoc-4-chloro-D-Phe-OH | 142994-19-2 | ʻO ka hapa nui o nā huahana | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 5 | Fmoc-D-Cit-OH | 200344-33-8 | ʻO Cetrorelix | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤1.0% |
| 6 | Fmoc-D-Ala-OH.H2O | 79990-15-1 | ʻO ka hapa nui o nā huahana | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤6.5% |
| 7 | Fmoc-D-Aph(tBuCbm)-OH | 1433975-21-3 | ʻO Degarelix | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 8 | Fmoc-D-Aph(Cbm)-OH | 324017-22-3 | ʻO Degarelix | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 9 | Fmoc-L-Aph(L-Hor)-OH | 1253282-31-3 | ʻO Degarelix | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 10 | Fmoc-L-Lys(iPr,Boc)-OH | 201003-48-7 | ʻO 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% |
* ʻO Max1 = ʻO ka nui o ka haumia ʻike ʻole ʻia
Hōʻailona ʻē aʻe:
- Acetic Acid: ≤0.02% (Huahana a pau)
- Ethyl Acetate: ≤0.5% (Huahana a pau)
- Waiʻona: ≤0.5% (Huahana a pau)
ʻO TOC a me ka conductivity o nā lako nui a me nā wahi hoʻihoʻi e nānā ʻia i kēlā me kēia manawa. Mālama ʻia ʻo TOC e QC i kēlā me kēia pule. Mālama ʻia ka conductivity ma ka pūnaewele a hoʻopaʻa ʻia e ka mea hoʻokele wai hoʻomaʻemaʻe i hoʻokahi manawa i kēlā me kēia ʻehā hola. Nānā ʻia ka conductivity ma ka RO kumu, RO lua, EDI a me ka helu hoʻihoʻi o ka ʻōnaehana hoʻolaha. Aia ka ʻōlelo kikoʻī o ka wai i hoʻomaʻemaʻe ʻia a hoʻokō i nā kikoʻī i wehewehe mua ʻia ʻaʻole ʻoi aku ma mua o 1.3 µs/cm ma 25°C (USP). No ka lako nui a me ka helu hoʻi, hoʻāʻo piha. hana ʻia i kēlā me kēia pule, no ka hoʻohana ʻana i nā wahi ʻē aʻe i ka loop circulating, hoʻāʻo piha ʻia i hoʻokahi manawa i kēlā me kēia mahina. Loaʻa ka hoʻāʻo piha i nā huapalapala, pH, nitrate, nitrite, ammonia, conductivity, TOC, non-volatile substances, heavy metals, microbial limits and bacterial endotoxin.