NO | Ibicuruzwa | URUBANZA No. | Gusaba | Icyerekezo Cyiza Cyerekana | ||||
Isuku | Isomer | Umwanda wihariye | * Max1 | Ubushuhe | ||||
1 | Fmoc-3- (2-naphthyl) -D-Ala-OH | 138774-94-4 | Ibicuruzwa byinshi | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
2 | Ac-3- (2-naphthyl) -D-Ala-OH | 37440-01-0 | Ibicuruzwa byinshi | ≥99.0% | ≤0.2% | ≤0.3% | ≤0.3% | ≤1.0% |
3 | Fmoc-3- (3-pyridinyl) -D-Ala-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 | Cetrorelix | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤1.0% |
6 | Fmoc-D-Ala-OH.H2O | 79990-15-1 | Ibicuruzwa byinshi | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | .5 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 | Kurwanya | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
16 | Fmoc-D-Lys (nicotinoyl) -OH | 252049-12-0 | Kurwanya | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
* Max1 = Impanuka itazwi
Ibindi bipimo:
- Acide Acike: ≤0.02% (Ibicuruzwa byose)
- Ethyl Acetate: ≤0.5% (Ibicuruzwa byose)
- Inzoga: ≤0.5% (Ibicuruzwa byose)
TOC hamwe nuburyo bwo gutanga ibintu byingenzi no kugaruka bikurikiranwa buri gihe.TOC ikurikiranwa na QC buri cyumweru.Imikorere ikurikiranwa kumurongo kandi ikandikwa nuwashinzwe amazi meza asukuye rimwe mumasaha ane.Imiyoboro ikurikiranwa kuri RO ibanza, RO ya kabiri, EDI hamwe nibisubizo byose byo kugabura sisitemu.Ibisobanuro byamazi meza birahari kandi bihuye nibisobanuro byateganijwe bitarenze 1.3 µs / cm kuri 25 ° C (USP).Kubintu nyamukuru byo gutanga no kugaruka, ikizamini cyuzuye.ikorwa buri cyumweru, kubindi ukoresheje ingingo mukuzenguruka, ikizamini cyuzuye gikorwa rimwe mukwezi.Ikizamini cyuzuye kirimo inyuguti, pH, nitrate, nitrite, ammonia, imiyoboro, TOC, ibintu bidahindagurika, ibyuma biremereye, imipaka ya mikorobe na endotoxine ya bagiteri.