NO | Ibicuruzwa | Kas Oya | Gusaba | Ikimenyetso Cyingenzi | ||||
Ubuziranenge | Isomer | Umwanda wihariye | * Max1 | Ubuhehere | ||||
1 | FMOC-3- (2-Naphthyl) -D-ALO-OH | 138774-94-4-4-9 | Ibicuruzwa byinshi | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
2 | AC-3- (2-Naphthyl) -d-ala-yewe | 37440-01-0 | Ibicuruzwa byinshi | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
3 | FMOC-3- (3-Pyridinyl) -D-ALO-OH | 142994-45-4 | Ibicuruzwa byinshi | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
4 | Fmoc-4-chloro-d-phe-oh | 142994-19-2 | Ibicuruzwa byinshi | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
5 | FMOC-D-CIT-OH | 200344-33-8-8 | Cetrorelix | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤1.0% |
6 | FMOC-D-ALO-OH.H2O | 79990-15-1 | Ibicuruzwa byinshi | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤6.5% |
7 | FMOC-D-APH (TBUCBM) -Oh | 1433975-21-3 | Dedarelix | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
8 | FMOC-D-AP (CBM) -Oh | 324017-22-3 | Dedarelix | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
9 | FMOC-L-APH (L-Hor) -Oh | 1253282-31-31-3 | Dedarelix | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
10 | FMOC-L-LYS (IPR, Boc) -Oh | 201003-48-7 | Dedarelix | ≥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-HOMAARG (et) 2-oh.hcl | 2098497-24-4 | Ganirelix | ≥95.0% | ≤0.5% | ≤1.0% | ≤2.0% | ≤2.0% |
15 | FMOC-LYS (Nikotinoyl) -Oh | 252049-11-9 | Antide | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
16 | FMOC-D-Lys (Nikotinoyl) -Oh | 252049-12-0 | Antide | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
* Max1 = umwanda utazwi
Ikindi kimenyetso:
- acide ya acetike: ≤0.02% (ibicuruzwa byose)
- Ethyl Acetate: ≤0.5% (ibicuruzwa byose)
- Inzoga: ≤0.5% (ibicuruzwa byose)
Toc na Unvite yo gutanga no gutangwa amanota akurikiranwa buri gihe. Toc irakurikiranwa na QC kuri buri cyumweru. Gukurikiranira kumurongo kandi byanditswe na sitasiyo yamazi yuzuye igihe buri masaha ane. Imyitwarire ikurikiranwa ku Roma Yibanze, Ediyo hamwe n'inyuma ya sisitemu yo gukwirakwiza. Ibisobanuro byamazi byejejwe birahari kandi bihuye nibisobanuro byasobanuwe mbere bitarenze 1.3 μs / cm kuri 25 ° C (USP). Kubwo gutanga nyamukuru no kugaruka ingingo, ikizamini cyuzuye. ikorwa buri cyumweru, kubindi bakoresheje ingingo mugukwirakwiza, ikizamini cyuzuye gikorwa rimwe mukwezi. Ikizamini cyuzuye kirimo inyuguti, PH, Nitrite, Ammomiya, Amahirwe, Toc, ibintu bidahindagurika, imipaka iremereye, imipaka ya mikorobe na bagiteri endotoxin.