Awọn ọja
Didara to gaju China Pharmaceutical CAS 679809-58-6 Enoxaparin Sodium Antiviral Enoxaparin Sodium Enoxaparin
A ni igberaga fun idunnu olura nla ati itẹwọgba jakejado nitori ilepa itẹramọṣẹ wa ti oke ti iwọn kọọkan lori ojutu ati atunṣe fun Didara to gaju China Pharmaceutical CAS 679809-58-6Enoxaparin iṣuu sodaAntiviral Enoxaparin Sodium Enoxaparin, A jẹ ọkan lati ọdọ awọn aṣelọpọ 100% ti o tobi julọ ni Ilu China.Ọpọlọpọ awọn ile-iṣẹ iṣowo nla gbe ọja wọle lati ọdọ wa, nitorinaa a yoo fun ọ ni ami idiyele ti o munadoko julọ pẹlu gbogbo didara kanna ti o ba nifẹ si wa.
A ni igberaga fun idunnu olura nla ati itẹwọgba jakejado nitori ilepa itẹramọṣẹ wa ti oke ti sakani kọọkan lori ojutu ati atunṣe funChina Enoxaparin, Enoxaparin iṣuu soda, Iṣakoso didara ti o muna ni a ṣe ni ọna asopọ kọọkan ti gbogbo ilana iṣelọpọ.Da lori ọja ti o ni agbara giga ati pipe ṣaaju-tita / iṣẹ lẹhin-tita ni imọran wa, diẹ ninu awọn alabara ti ṣe ifowosowopo pẹlu wa fun diẹ sii ju ọdun 5 lọ.
Ẹ̀kúnrẹ́rẹ́
1. Awọn ohun kikọ: Funfun tabi fere funfun lulú, gíga hygroscopic.
2. Orisun: Porcine ifun mucosa.
3. Ilana: Heparin soda ti wa ni jade lati ilera porcine ifun mucosa.
4. Awọn itọkasi ati awọn lilo: Ọja yi ti wa ni o kun ti a lo fun thromboembolic arun idena, paapa dara fun awọn nilo ti anticoagulant ni kiakia, gẹgẹ bi awọn: 1. Àìdá tabi onibaje iṣọn thrombosis tabi ko si significant sisan ẹjẹ san ìmúdàgba ayipada ti ẹdọforo embolism (PE) .Heparin le da itẹsiwaju embolus duro lati ṣe akoko fun thrombolysis lẹẹkọkan ti ara.2. Idena ati itoju ti Atrial fibrillation pẹlu embolism.3. Itoju ti tete tan kaakiri intravascular coagulation (DIC).4. Idena ati itọju thrombosis agbeegbe tabi ailagbara myocardial.5. Omiiran anticoagulation in vitro: gẹgẹbi iṣẹ-abẹ inu ọkan ati ẹjẹ, iṣọn-ẹjẹ in vitro, hemodialysis, angiography, tun le ṣee lo fun gbigbe ẹjẹ tabi igbaradi ayẹwo ẹjẹ, ni bayi awọn itọkasi akọkọ ti ohun elo heparin jẹ thrombosis ti iṣan ti o jinlẹ (DVT), PE ati thrombosis. ni awọn alaisan ti o ni eewu giga.
Kini idi ti wa?
· Ti kọja GMP Kannada
· ọdun 27 ti itan-akọọlẹ R&D henensiamu ti ibi
· Awọn ohun elo aise jẹ itọpa
· Ni ibamu pẹlu USP, EP ati boṣewa alabara
Ṣe okeere si awọn orilẹ-ede ati agbegbe ti o ju 30 lọ
· Ni agbara ti iṣakoso eto didara gẹgẹbi US FDA, Japan PMDA, South Korea MFDS, ati bẹbẹ lọ.
Sipesifikesonu
| Awọn nkan Idanwo | Ile-iṣẹ pato | ||
| EP | USP | ||
| Awọn ohun kikọ | Funfun tabi fere funfun lulú, gíga hygroscopic | ||
| Idanimọ | Thrombotest: Ṣe ibamu | Idanimọ Chromatographic: Ṣe ibamu | |
| 1H NMR julọ.Oniranran: ibamu | 1H NMR julọ.Oniranran: ibamu | ||
| Chromatography Liquid: Ṣe deede | Iwọn-apapọ iwuwo molikula: 15000 ~ 19000 | ||
| Iṣuu soda: Ṣe deede | Iṣuu soda: Ṣe deede | ||
| Anti-ifosiwewe Xa si egboogi-ifosiwewe IIa ratio: 0.9 ~ 1.1 | Anti-ifosiwewe Xa si egboogi-ifosiwewe IIa ratio: 0.9 ~ 1.1 | ||
| Idanwo | wípé ati awọ | wípé: Clear, Awọ: nipasẹ 5 tabi dara julọ | ———— |
| Nitrojiini | 1.5-2.5% (ohun elo gbigbẹ) | 1.3-2.5% (ohun elo gbigbẹ) | |
| Awọn aimọ ti Nucleotidic | A260≤ 0.15 (4mg/ml) | ≤ 0.1 (w/w) | |
| Awọn nkan ti o jọmọ | Ni ibamu | ———— | |
| Idinwo ti galactosamine ni apapọ hexosamine | ———— | ≤ 1.0% | |
| Sulfate chondroitin ti o pọju | ———— | Ni ibamu | |
| pH | 5.5-8.0 (1%) | 5.5-7.5 (1%) | |
| Pipadanu lori gbigbe | ≤ 8.0% (60℃ Gbẹ ninu Igbale, 3h）) | ≤ 5.0% (60℃ Gbẹ ninu Igbale, 3h）) | |
| Aloku lori iginisonu | ———— | 28.0% ~ 41.0% | |
| Endotoxin kokoro arun | ≤ 0.01 IU / International Unit ti Heparin | ≤ 0.03 USP U / International Unit ti Heparin | |
| Irin eru | 30ppm | 30ppm | |
| Iṣuu soda | 10.5 ~ 13.5% (ohun elo gbigbẹ) | ———— | |
| Awọn ọlọjẹ | ≤ 0.5% (ohun elo gbigbẹ) | ≤ 0.1% (Ipin iwuwo) | |
| Iṣẹ-ṣiṣe | ≥ 180 IU/mg (ohun elo gbigbẹ) | ≥ 180 USP U/mg (ohun elo gbigbẹ) | |
| Makirobia impurities | TAMC | ≤ 1000cfu/g | ≤ 1000cfu/g |
| TYMC | ≤ 100cfu/g | ≤ 100cfu/g | |
| E.coli | Ni ibamu | Ni ibamu | |
| Staphylococcus aureus | Ni ibamu | Ni ibamu | |
| Salmonella | Ni ibamu | Ni ibamu | |
A ni igberaga fun idunnu olura nla ati itẹwọgba jakejado nitori ilepa itẹramọṣẹ wa ti oke ti iwọn kọọkan lori ojutu ati atunṣe fun Didara to gaju China Pharmaceutical CAS 679809-58-6 Enoxaparin Sodium Antiviral Enoxaparin Sodium Enoxaparin, A jẹ ọkan lati awọn tobi 100% awọn olupese ni China.Ọpọlọpọ awọn ile-iṣẹ iṣowo nla gbe ọja wọle lati ọdọ wa, nitorinaa a yoo fun ọ ni ami idiyele ti o munadoko julọ pẹlu gbogbo didara kanna ti o ba nifẹ si wa.
Oniga nlaChina Enoxaparin, Enoxaparin Sodium, Iṣakoso didara ti o muna ni a ṣe ni ọna asopọ kọọkan ti gbogbo ilana iṣelọpọ.Da lori ọja ti o ni agbara giga ati pipe ṣaaju-tita / iṣẹ lẹhin-tita ni imọran wa, diẹ ninu awọn alabara ti ṣe ifowosowopo pẹlu wa fun diẹ sii ju ọdun 5 lọ.
