I-GNRH ANTANCIST isetshenziselwa ukuhlanganiswa kwama-peptides
Imininingwane Yomkhiqizo
| NO | Imikhiqizo | Case No. | Isicelo | Isikhombi sekhwalithi esemqoka | ||||
| Ubumsulwa | Isikhungo | Ukungcola Okuthile | * Max1 | Ubumanzi | ||||
| 1 | I-FMOC-3- (2-Naphthyl) -D-ALA-OH | 138774-94-4 | Imikhiqizo eminingi | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 2 | I-AC-3- (2-Naphthyl) -D-Ala-Oh | 37440-01-0 | Imikhiqizo eminingi | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 3 | I-FMOC-3- (3-Pyridinyl) -D-ALA-OH | 142994-45-4 | Imikhiqizo eminingi | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 4 | I-FMOC-4-Chloro-D-phe-phehe-Oh | 142994-19-2 | Imikhiqizo eminingi | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 5 | I-FMOC-D-cit-Oh | Ngo-200344-33-8 | Cetrorelix | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤1.0% |
| 6 | I-FMOC-D-ALA-OH2O | 79990-15-1 | Imikhiqizo eminingi | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤6.5% |
| 7 | I-FMOC-D-APH (TBUCBM) -OH | 1433975-21-3 | UDererelix | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 8 | I-FMOC-D-APH (CBM) -OH | 324017-22-3 | UDererelix | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 9 | I-FMOC-L-APH (L-HOR) -OH | 1253282-31-3 | UDererelix | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 10 | I-FMOC-L-LYS (IPR, BOC) -OH | Ngo-201003-48-7 | UDererelix | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 11 | I-FMOC-N-Me-TR (TBU) -OH | 133373-24-7 | -Abarix | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 12 | I-FMOC-D-ASN (TRT) -OH | 180570-71-2 | -Abarix | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
| 13 | I-FMOC-Homoarg (et) 2-Oh.hcl | Ngo-1864003-26-8 | Ganirelix | ≥95.0% | ≤0.5% | ≤1.0% | ≤2.0% | ≤2.0% |
| 14 | I-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 | 2520404-11-9 | Igugu | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
| 16 | I-FMOC-D-LYS (NICOTINOYL) -OH | 252049-12-0-0-0 | Igugu | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
* Max1 = ukungcola okungaziwa
Enye inkomba:
- I-acetic acid: ≤0.02% (yonke imikhiqizo)
- I-Ethyl Acetate: ≤0.5% (yonke imikhiqizo)
- Utshwala: ≤0.5% (yonke imikhiqizo)
Toc kanye nokwenza
I-TOC kanye nokuvunyelwa kokuhlinzekwa okuphambili kanye namaphuzu wokubuyisa kubhekwa ngezikhathi ezithile. I-TOC ibhekwa yi-QC kuwo masonto onke. Ukuvuselelwa kubhekwe ku-inthanethi futhi kuqoshwe ngo-opharetha wesiteshi samanzi ahlanziwe kanye njalo emahoreni amane. Ukuvuselelwa kubhekwe e-Primary Ro, Secondary Ro, EDI kanye nenani lokubuyisa eliphelele lohlelo lokusabalalisa. Ukucaciswa kwamanzi ahlanziwe kusendaweni futhi kuvumelana nokucaciswa kwangaphambi kokuchazwa okungaphezu kwama-1.3 μs / cm ku-25 ° C (USP). Okokuhlinzekwa okusemqoka kanye namaphoyinti wokubuyisa, ukuhlolwa okugcwele. Kwenziwa njalo ngeviki, kwabanye ukusebenzisa iphuzu ku-loop yokujikeleza, ukuhlolwa okugcwele kwenziwa kanye njalo ngenyanga. Ukuhlolwa okugcwele kufaka phakathi izinhlamvu, i-PH, nitrate, nitrite, i-ammonia, i-ammonia, i-toc, izinto ezingezona ezoshintshashintshashintshayo, imikhawulo yegciwane, imikhawulo yegciwane kanye ne-bacterial endotoxin.
