Twishimiye umunezero mwinshi wabaguzi no kwemerwa kwinshi kuberako dukomeje gushakisha hejuru yurwego buri kimwe mubisubizo no gusana imiti yo mu rwego rwo hejuru Ubushinwa Pharmaceutical CAS 679809-58-6Sodium ya EnoxaparinAntiviral Enoxaparin Sodium Enoxaparin, Turi umwe mubakora inganda nini 100% mubushinwa.Amasosiyete menshi yubucuruzi atumiza ibicuruzwa muri twe, bityo tuzaguha igiciro cyiza cyane hamwe nubwiza bumwe niba ubishaka.
Twishimiye umunezero mwinshi wabaguzi no kwemerwa kwinshi kuberako dukomeje gushakisha hejuru yurwego buri kimwe mubisubizo no gusanaUbushinwa Enoxaparin, Sodium ya Enoxaparin, Igenzura rikomeye rikorwa muri buri murongo wibikorwa byose. Turizera rwose ko tuzashyiraho ubufatanye bwa gicuti kandi bwunguka nawe.Dushingiye ku bicuruzwa byiza kandi byiza mbere yo kugurisha / nyuma yo kugurisha ni igitekerezo cyacu, abakiriya bamwe bari barakoranye natwe imyaka irenga 5.
1. Inyuguti: Ifu yera cyangwa hafi yera, hygroscopique cyane.
2. Inkomoko: mucosa amara.
3. Inzira: Sodium ya Heparin ikurwa muri mucosa nziza yo mu mara.
4. Ibyerekana kandi bikoreshwa: Iki gicuruzwa gikoreshwa cyane cyane mukurinda indwara ya tromboembolique, cyane cyane ikenewe mugukenera anticoagulant byihuse, nka: 1. 1. Trombose ikaze cyangwa idakira cyangwa nta maraso akomeye atembera neza ihinduka ryimpyiko (PE) .Heparin Irashobora kwaguka kwa embolus kugirango ikore umwanya wa trombolysis yumubiri.2. Kwirinda no kuvura fibrillation ya Atrial hamwe na embolism.3. Kuvura hakiri kare gukwirakwiza imitsi y'amaraso (DIC).4. Kwirinda no kuvura periferique arterial trombose cyangwa infirasiyo ya myocardial.5. Ibindi muri vitro anticoagulation: nko kubaga umutima-mitsi, kubagwa kwa vitro, hemodialysis, angiography, nabyo birashobora gukoreshwa muguterwa cyangwa gutegura amaraso, kuri ubu ibimenyetso byingenzi byerekana imiti ya heparin ni trombose ndende (DVT), PE na trombose mu barwayi bafite ibyago byinshi.
· Yatsinze abashinwa GMP
· Imyaka 27 ya enzyme ya biologiya R&D amateka
· Ibikoresho bibisi birashobora gukurikiranwa
· Kurikiza USP 、 EP hamwe nibisanzwe byabakiriya
· Kohereza mu bihugu n'uturere birenga 30
· Ifite ubushobozi bwo gucunga neza sisitemu nka US FDA, Ubuyapani PMDA, Koreya yepfo MFDS, nibindi.
Ibizamini | Ibisobanuro bya sosiyete | ||
EP | USP | ||
Inyuguti | Ifu yera cyangwa hafi yera, hygroscopique cyane | ||
Kumenyekanisha | Thrombotest: Ihuza | Indangamuntu ya Chromatografiya: Ihuza | |
1H NMR Ikirangantego: Ihuza | 1H NMR Ikirangantego: Ihuza | ||
Amazi ya Chromatografiya: Ihuza | Uburemere-buringaniye bwa molekuline: 15000 ~ 19000 | ||
Sodium: Ihuza | Sodium: Ihuza | ||
Kurwanya ibintu Xa kugereranya anti-factor IIa: 0.9 ~ 1.1 | Kurwanya ibintu Xa kugereranya anti-factor IIa: 0.9 ~ 1.1 | ||
Ibizamini | Kugaragara no kurangi | Ibisobanuro: Birasobanutse, Ibara: kuri 5 cyangwa byiza | ———— |
Azote | 1.5 ~ 2,5% substance ibintu byumye) | 1.3 ~ 2,5% substance ibintu byumye) | |
Nucleotidic umwanda | A260≤ 0.15 (4mg / ml) | ≤ 0.1 (w / w) | |
Ibintu bifitanye isano | Guhuza | ———— | |
Imipaka yagalactosamine muri hexosamine yose | ———— | ≤ 1.0% | |
Kurenza urugero rwa chondroitine sulfate | ———— | Guhuza | |
pH | 5.5 ~ 8.0 (1%) | 5.5 ~ 7.5 (1%) | |
Gutakaza kumisha | ≤ 8.0% (60 ℃ Kuma muri Vacuum, 3h) | ≤ 5.0% (60 ℃ Kuma muri Vacuum, 3h) | |
Ibisigisigi byo gutwikwa | ———— | 28.0% ~ 41.0% | |
Indwara ya bagiteri | ≤ 0.01 IU / Igice mpuzamahanga cya Heparin | ≤ 0.03 USP U / Ishami mpuzamahanga rya Heparin | |
Icyuma kiremereye | ≤ 30ppm | ≤ 30ppm | |
Sodium | 10.5 ~ 13.5% substance ibintu byumye) | ———— | |
Poroteyine | ≤ 0.5% substance ibintu byumye) | ≤ 0.1% ratio Ikigereranyo cy'uburemere) | |
Igikorwa | ≥ 180 IU / mg substance ibintu byumye) | ≥ 180 USP U / mg substance ibintu byumye) | |
Microbial Impurities | TAMC | ≤ 1000cfu / g | ≤ 1000cfu / g |
TYMC | C 100cfu / g | C 100cfu / g | |
E.coli | Guhuza | Guhuza | |
Staphylococcus aureus | Guhuza | Guhuza | |
Salmonella | Guhuza | Guhuza |
Twishimiye umunezero mwinshi wabaguzi no kwemerwa kwinshi kuberako dukomeje gushakisha hejuru yurwego buri kimwe mubisubizo no gusana imiti yo mu rwego rwo hejuru Ubushinwa Pharmaceutical CAS 679809-58-6 Enoxaparin Sodium Antiviral Enoxaparin Sodium Enoxaparin, Turi umwe muri ba binini 100% mu Bushinwa.Amasosiyete menshi yubucuruzi atumiza ibicuruzwa muri twe, bityo tuzaguha igiciro cyiza cyane hamwe nubwiza bumwe niba ubishaka.
Ubwiza bwo hejuruUbushinwa Enoxaparin, Sodium ya Enoxaparin, Igenzura rikomeye rikorwa muri buri murongo wibikorwa byose. Turizera rwose ko tuzashyiraho ubufatanye bwa gicuti kandi bwunguka nawe.Dushingiye ku bicuruzwa byiza kandi byiza mbere yo kugurisha / nyuma yo kugurisha ni igitekerezo cyacu, abakiriya bamwe bari barakoranye natwe imyaka irenga 5.