• Cov khoom
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Cov khoom

High Performance Tuam Tshoj Heparin Sodium


  • CAS Nr.:9 041-08-1
  • HS CODE:3001.9010.00 Nws
  • Kev Pabcuam Cov Ntaub Ntawv:Suav-GMP, DMF
  • Pharmacopoeia standard:EP/USP
  • Product Detail

    Khoom cim npe

    Peb sim ua kom zoo tshaj plaws, tuam txhab cov neeg siv khoom ", vam tias yuav dhau los ua pab pawg kev koom tes zoo tshaj plaws thiab cov thawj coj ua lag luam rau cov neeg ua haujlwm, cov neeg muag khoom thiab cov neeg siv khoom, paub txog qhov tsim nyog thiab txuas ntxiv tshaj tawm rau Kev Ua Haujlwm Siab.Tuam Tshoj Heparin Sodium, Peb tsuas yog tsis tsuas yog xa cov khoom zoo tshaj plaws rau peb cov neeg siv khoom, tab sis qhov tseem ceeb ntxiv yog peb cov kev pabcuam zoo tshaj plaws ntxiv rau cov nqi muag khoom sib tw.
    Peb sim ua kom zoo tshaj plaws, tuam txhab cov neeg siv khoom ", vam tias yuav dhau los ua pab pawg kev koom tes zoo tshaj plaws thiab cov thawj coj ua lag luam rau cov neeg ua haujlwm, cov neeg muag khoom thiab cov neeg siv khoom, paub txog qhov tsim nyog thiab txuas ntxiv tshaj tawm rauTuam Tshoj Heparin Sodium, Cov neeg siv khoom txaus siab ib txwm yog peb qhov kev tshawb nrhiav, tsim kom muaj txiaj ntsig rau cov neeg siv khoom yog ib txwm peb lub luag haujlwm, kev sib raug zoo ntawm kev lag luam mus sij hawm ntev yog qhov peb tab tom ua.Peb tau yog ib tus neeg koom tes nrog koj cov ntaub ntawv hauv Suav teb.Tau kawg, lwm yam kev pabcuam, xws li kev sab laj, tuaj yeem muab tau thiab.

    Paub meej

    1. Cim: Dawb los yog yuav luag dawb hmoov, hygroscopic heev.

    2. Source: Porcine plab hnyuv mucosa.

    3. Cov txheej txheem: Heparin sodium yog muab rho tawm los ntawm kev noj qab haus huv porcine plab hnyuv mucosa.

    4. Cov lus qhia thiab kev siv: Cov khoom no tsuas yog siv rau kev tiv thaiv kab mob thromboembolic, tshwj xeeb tshaj yog tsim nyog rau kev xav tau ntawm anticoagulant sai, xws li: 1. mob venous thrombosis los yog tsis muaj ntshav txaus dynamic hloov pulmonary embolism (PE).Heparin tuaj yeem nres embolus txuas ntxiv los ua lub sijhawm rau thrombolysis ntawm lub cev.2. Kev tiv thaiv thiab kev kho mob ntawm Atrial fibrillation nrog embolism.3. Kev kho mob thaum ntxov diffuse intravascular coagulation (DIC).4. Kev tiv thaiv thiab kev kho mob ntawm peripheral arterial thrombosis lossis myocardial infarction.5. Lwm yam hauv vitro anticoagulation: xws li kev phais plawv, hauv vitro ncig, hemodialysis, angiography, kuj tuaj yeem siv rau kev tso ntshav lossis ntshav npaj, tam sim no cov lus qhia tseem ceeb ntawm daim ntawv thov heparin yog cov hlab ntsha sib sib zog nqus (DVT), PE thiab thrombosis. nyob rau hauv cov neeg mob uas muaj kev pheej hmoo siab.

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    Vim li cas peb?

    · Dhau Suav GMP

    · 27 xyoo ntawm biological enzyme R & D keeb kwm

    · Cov ntaub ntawv nyoos yog traceable

    · Ua raws li USP, EP thiab cov neeg siv khoom tus qauv

    · Export rau ntau tshaj 30 lub teb chaws thiab cheeb tsam

    · Muaj peev xwm ntawm kev tswj xyuas zoo xws li US FDA, Nyiv PMDA, Kaus Lim Qab Teb MFDS, thiab lwm yam.

    Specification

    Cov khoom kuaj

    Tuam txhab Specification

    EP

    USP

    Cov cim

    Dawb los yog yuav luag dawb hmoov, hygroscopic heev

    Kev txheeb xyuas

    Thrombotest: Ua raws

    Chromatographic tus kheej: Conforms

    1H NMR Spectrum: Ua raws

    1H NMR Spectrum: Ua raws

    Liquid Chromatography: Conforms

    Qhov hnyav-qhov nruab nrab molecular hnyav: 15000 ~ 19000

    Sodium: Conforms

    Sodium: Conforms

    Anti-factor Xa rau anti-factor IIa piv: 0.9 ~ 1.1

    Anti-factor Xa rau anti-factor IIa piv: 0.9 ~ 1.1

    Kev sim

    Clarity thiab xim

    Clarity: Ntshiab, Xim: los ntawm 5 lossis zoo dua

    ——————

    Nitrogen

    1.5 ~ 2.5% (cov khoom qhuav)

    1.3 ~ 2.5% (cov khoom qhuav)

    Nucleotidic impurities

    A260≤ 0.15 (4mg / ml)

    ≤ 0.1 (w / w)

    Cov khoom muaj feem xyuam

    Ua raws

    ——————

    Kev txwv ntawm galactosamine hauv tag nrho hexosamine

    ——————

    ≤ 1.0%

    Oversulfated chondroitin sulfate

    ——————

    Ua raws

    pH

    5.5 ~ 8.0 (1%)

    5.5 ~ 7.5 (1%)

    Poob rau ziab

    ≤ 8.0% (60 ℃ Qhuav hauv Nqus tsev, 3h)

    ≤ 5.0% (60 ℃ Qhuav hauv Nqus tsev, 3h)

    Residue ntawm ignition

    ——————

    28.0% ~ 41.0%.

    Cov kab mob endotoxin

    ≤ 0.01 IU/International Unit of Heparin

    ≤ 0.03 USP U/International Unit of Heparin

    Hnyav hlau

    ≤ 30ppm

    ≤ 30ppm

    Sodium

    10.5 ~ 13.5% (cov khoom qhuav)

    ——————

    Cov protein

    ≤ 0.5% (cov khoom qhuav)

    ≤ 0.1% (Qhov hnyav piv)

    Kev ua si

    ≥ 180 IU / mg (cov khoom qhuav)

    ≥ 180 USP U / mg (cov khoom qhuav)

    Microbial impurities

    TAMC

    ≤ 1000cfu / g

    ≤ 1000cfu / g

    TYMC

    ≤ 100cfu / g

    ≤ 100cfu / g

    E.coli

    Ua raws

    Ua raws

    Staphylococcus aureus

    Ua raws

    Ua raws

    Salmonella

    Ua raws

    Ua raws

    Peb sim ua kom zoo tshaj plaws, tuam txhab cov neeg siv khoom ", vam tias yuav dhau los ua pab pawg kev koom tes zoo tshaj plaws thiab cov thawj coj ua lag luam rau cov neeg ua haujlwm, cov chaw muag khoom thiab cov neeg siv khoom, paub txog qhov tsim nyog thiab txuas ntxiv tshaj tawm rau Kev Ua Haujlwm Zoo Tuam Tshoj Heparin Sodium Peb tsuas yog tsis tsuas yog xa cov khoom zoo tshaj plaws rau peb cov neeg siv khoom. , tab sis qhov tseem ceeb ntxiv yog peb cov kev pabcuam zoo tshaj plaws ntxiv rau tus nqi muag khoom sib tw.
    Kev ua haujlwm siab Tuam Tshoj Heparin, Cov neeg siv khoom txaus siab yog ib txwm peb qhov kev tshawb nrhiav, tsim kom muaj txiaj ntsig rau cov neeg siv khoom yog ib txwm peb lub luag haujlwm, kev sib raug zoo ntawm kev lag luam ntev yog qhov peb tab tom ua.Peb tau yog ib tus neeg koom tes nrog koj cov ntaub ntawv hauv Suav teb.Tau kawg, lwm yam kev pabcuam, xws li kev sab laj, tuaj yeem muab tau thiab.


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    EHS
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