HK Neopharm Limited yog ib qho ntawm feem txhim khu kev qha manufacturers thiab lwm tus neeg ntawm terlipressin fda nyob rau hauv Suav teb, featured los ntawm cov khoom zoo thiab tus nqi zoo. Thov so assured mus yuav terlipressin fda hauv Tshuag ntawm no thiab tau txais cov lus hais los ntawm peb lub hoobkas. Customized xaj yog txais tos.
Terlipressin API (Terlipressin Active Pharmaceutical Ingredient) yog ib qho hluavtaws ntev - ua vasopressin analog nrog cov tshuaj ID CAS 14636-12-5. Nws yog cov khoom siv tseem ceeb rau kev saib xyuas tseem ceeb hauv kab mob siab, mob los ntshav thiab poob siab. Nrog Terlipressin FDA tso cai pom zoo, nws yog lub ntiaj teb thawj zaug thiab tsuas yog pom zoo API rau kev ua rau lub raum tsis zoo hauv hepatorenal syndrome. Nws ua lub luag haujlwm hloov tsis tau hauv kev txo qhov siab ntawm lub portal, tswj cov ntshav los ntshav, thim rov qab lub raum tsis ua haujlwm thiab txhim kho cov ciaj sia nyob hauv cov neeg mob hnyav.
Technical Specifications
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Khoom npe |
Terlipressin ua |
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Synonyms |
CAS 14636-12-5, Terlipressin API, Terlipressin fda pom zoo, Terlipressin hmoov |
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Yam ntxwv |
Dawb kom tawm -dawb lyophilized hmoov |
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CAS Nr |
14636-12-5 |
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Assay |
Ntau dua lossis sib npaug li 99% (HPLC, Raws li COA) |
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Formula |
C52H74N16O15S2 |
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Pob |
Pob txheej txheem |
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Cia |
Khaws ntawm -25 ~ -15 degree |
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Qauv |
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Raws li cov kws tshaj lij cov khoom siv raw khoom, peb koom tes nrog ntau tus GMP, FDA thiab CEP tau lees paub cov koom haum koom tes. Nrog lub peev xwm tsim khoom ruaj khov, kev tswj hwm nruj thiab kev pabcuam raws li thoob ntiaj teb, peb muab ib qho - nres cov kev daws teeb meem ntawm Terlipressin hmoov rau cov tuam txhab tshuaj npaj thoob ntiaj teb, cov chaw tsim tshuaj thaum muaj xwm txheej ceev thiab cov chaw tshawb fawb. Peb tuav qhov sib npaug ntawm qhov zoo thiab tus nqi los pab cov neeg siv khoom zoo txhawb R & D, sau npe thiab kev lag luam.
Cov yam ntxwv ntawm cov khoom
Terlipressin API yog tsim los ntawm cov txheej txheem ua ke ntawm cov khoom sib xyaw ua ke -theem peptide synthesis, kua-theem purification thiab lyophilization refinement. Peb nruj me ntsis tswj impurities, hlau ions thiab microbial theem thoob plaws hauv cov txheej txheem los xyuas kom meej lub purity thiab stability ntawm Terlipressin hmoov los ntawm qhov chaw. Cov khoom lag luam yog dawb rau tawm -cov hmoov dawb lyophilized nrog cov dej solubility zoo heev, hloov kho sai thiab tsis pom cov teeb meem txawv teb chaws, tsim nyog rau kev tsim cov tshuaj txhaj, lyophilized hmoov txhaj tshuaj thiab lwm yam kev npaj thaum muaj xwm ceev.
Cov ntaub ntawv tswj xyuas zoo: HPLC purity ruaj khov Ntau dua lossis sib npaug li 99.0%, tag nrho cov impurities Tsawg dua lossis sib npaug li 1.0%, qhov siab tshaj plaws ib qho impurity Tsawg dua lossis sib npaug li 0.5%; noo noo tsawg dua lossis sib npaug li 5.0%, acetate 5.0% -11.0%, peptide cov ntsiab lus Ntau dua lossis sib npaug li 80%; endotoxin<5 EU/mg; sterility and microbial limits meet injection-grade requirements. It complies with ICH Q7, USP, EP and CP standards and supports global registration.
Terlipressin API yog ib qho kev xaiv agonist rau vasopressin V1 receptors. Nws maj mam tso tawm lysine vasopressin hauv vivo nrog me me thiab ntev - cov nyhuv kav ntev. Cov ntaub ntawv kho mob qhia tau hais tias rau mob esophageal variceal los ntshav, hemostasis kev vam meej nce mus txog 85% -90%. Thaum ua ke nrog albumin rau hepatorenal syndrome, lub raum ua haujlwm thim rov qab tus nqi yog 29.1%, siab dua li 15.8% ntawm cov placebo pawg (p=0.012), uas tuaj yeem txo qhov kev pheej hmoo ntawm kev lim ntshav thiab kev tuag. Nws muaj ib nrab-lub neej ntawm li 40mins–4 teev, txhawb nqa cov hlab ntsha tsis tu ncua lossis kev txhaj tshuaj tas mus li, tsim nyog rau cov xwm txheej xwm txheej ceev xws li ICU, chav haujlwm xwm txheej ceev, chav haujlwm gastroenterology thiab chav ua haujlwm.
Terlipressin hmoov muaj cov khoom me me thiab cov dej zoo nrog D90 Tsawg dua lossis sib npaug li 30μm. Nws tuaj yeem npaj tau sai sai rau hauv kev txhaj tshuaj meej meej, txhim kho kev tsim khoom. Cov ntaub ntawv ruaj khov: ruaj khov rau 24 lub hlis ntawm 2-8℃hauv qhov ntim thiab lub teeb- pov thawj; cov tshuaj reconstituted yog ruaj khov mus txog 4 teev nyob rau hauv chav tsev kub, ua tau raws li lub ntiaj teb no txias saw cia thiab kev thauj mus los.
Hais txog kev nyab xeeb, Terlipressin API tau txais txiaj ntsig zoo tag nrho. Cov kev phiv tshwm sim feem ntau yog me me mus rau nruab nrab siab ntshav siab, mob plab thiab xeev siab, nrog rau qhov qis thiab tswj tau. Thaum siv raws li cov lus qhia thiab ntau npaum li cas, cov txiaj ntsig zoo tshaj qhov kev pheej hmoo ntawm cov xwm txheej ischemic thiab kev pheej hmoo ua pa, ua rau nws yog ib qho khoom siv ruaj khov rau thawj - kab mob tseem ceeb.
Full -Cycle Quality Control and Compliance Assurance
Tag nrho -Chain Traceability Management
Peb siv tag nrho -txheej txheem traceability tswj rau Terlipressin API los ntawm kev pib cov ntaub ntawv, synthesis, purification, lyophilization, crushing, filling thiab ntim rau cov khoom tiav soj ntsuam. Txhua batch ntawm Terlipressin hmoov yog muab ib tug tshwj xeeb batch naj npawb, nrog ua tiav cov ntaub ntawv thiab kev soj ntsuam cov ntaub ntawv khaws tseg, ua kom tag nrho traceability, soj ntsuam thiab rov- kuaj. Txhua qhov kev xa khoom yog muab nrog cov ntaub ntawv sau npe ua tiav suav nrog COA, HNMR, LC-MS, HPLC chromatograms, elemental impurities, microbiological cov ntaub ntawv thiab cov ntaub ntawv ruaj ntseg, uas zoo kawg nkaus txhawb Terlipressin FDA pom zoo- hais txog kev sau npe thiab kev tshuaj xyuas.
Cov qauv nruj nruj nrog cov qauv thoob ntiaj teb
Terlipressin API (CAS 14636-12-5) nruj me ntsis raws li ICH Q7, USP, EP thiab CP cov qauv. Peb ua cov kev ntsuam xyuas zoo xws li HPLC purity, GC residual solvents, elemental impurities, endotoxin, sterility thiab peptide cov ntsiab lus. Cov ntsuas kev ua tau zoo tau ua tiav raws li FDA cov cai thiab tuaj yeem siv ncaj qha rau Terlipressin FDA pom zoo txog kev npaj tsim kho, pab cov khoom lag luam nkag mus rau cov khw muag tshuaj loj xws li Tebchaws Meskas, Europe, Nyiv, Kaus Lim Qab Teb thiab Qab Teb Asia.
Cov txheej txheem txuas ntxiv thiab kev ua kom zoo
Kev txhawb nqa los ntawm kev txhim kho thev naus laus zis txuas ntxiv ntawm cov koom tes koom tes, peb niaj hnub txhim kho cov txheej txheem sib xyaw thiab ua kom huv ntawm Terlipressin API. Thaum txhim kho purity thiab stability, peb optimize Terlipressin nqi thiab muab efficiency. Peb tau tsim ib qho kev ua tiav rau kev sib txawv, kev hloov pauv thiab kev tshuaj xyuas txhua xyoo kom paub meej thiab ruaj khov zoo ntawm txhua pawg ntawm Terlipressin hmoov thiab muab cov neeg siv khoom nrog ntev -lub sij hawm txhim khu kev qha raw khoom.
Daim ntawv thov Scenario
Kev Kho Mob Xwm Ceev ntawm Hepatorenal Syndrome (HRS)
Terlipressin API yog cov khoom siv tseem ceeb qhia tau meej meej pom zoo raws li Terlipressin FDA pom zoo rau kev ua haujlwm rau lub raum sai sai hauv hepatorenal syndrome. Nws tuaj yeem txhim kho lub raum perfusion, nce glomerular pom tus nqi, rov qab lub raum tsis ua haujlwm, txo cov qib creatinine thiab txo cov kev xav tau lim ntshav, yeej lub sijhawm tseem ceeb rau kev hloov lub siab.
Acute Esophageal Variceal Bleeding
Terlipressin tuaj yeem ua rau cov hlab ntsha splanchnic thiab txo qhov siab ntawm lub portal kom ceev nrooj tswj cov hlab ntsha tawg los ntshav uas tshwm sim los ntawm daim siab cirrhosis. 24-teev hemostasis tus nqi zoo tshaj 85%, ua rau nws yog thawj kab xwm txheej ceev raw khoom pom zoo los ntawm cov lus qhia thoob ntiaj teb.
Critical Shock thiab Perioperative Support
Terlipressin-Cov tshuaj muaj feem xyuam tuaj yeem siv rau norepinephrine- tiv thaiv kab mob septic shock kom nce siab txhais tau tias cov hlab ntsha thiab txhim kho cov ntaub so ntswg perfusion. Nws kuj tseem siv rau kev kho mob thaum muaj xwm txheej ceev ntawm cov ntshav tom qab kev phais, kev tsis txaus siab ascites thiab gynecological los ntshav, txhim kho qhov ua tiav ntawm kev kho mob tseem ceeb.
Innovative Drug R & D thiab Standard Reference
Terlipressin API tuaj yeem siv los ua tus qauv siv los txhawb kev muag tshuaj, tshuaj toxicology, pharmacokinetics, kev tshuaj ntsuam xyuas thiab kev tsim qauv zoo. Nws kuj tseem siv rau hauv R&D ntawm ntev - ua peptides, prodrugs thiab cov phiaj xwm npaj, nthuav dav daim ntawv thov hauv kev kho mob tseem ceeb.
Ntim thiab thauj
Terlipressin hmoov yog lub tshuab nqus tsev vacuum- kaw hauv chaw muag tshuaj- qib lyophilized vials lossis aluminium foil hnab nrog desiccants thiab tiv thaiv lub teeb, thiab cov pob sab nrauv yog noo noo- pov thawj thiab oxidation- tiv thaiv kom ruaj khov thiab kev thauj mus los. Standard specifications: 100mg, 1g, 10g, 100g, 500g, 1kg. Customized Terlipressin ntim tau txais kev txhawb nqa.
Tag nrho cov txheej txheem yog thauj mus rau hauv cov hlua txias thiab lub teeb -cov ntaub ntawv pov thawj ntawm 2-8℃nrog lub sijhawm tiag tiag - ntsuas kub. Kev faib tawm hauv tsev yog tswj hwm los ntawm cov tuam txhab kws tshuaj logistics; Kev thauj mus los thoob ntiaj teb ua raws li UN thiab IATA cov kev cai, muab kev pabcuam huab cua, dej hiav txwv thiab thoob ntiaj teb nrog kev taug qab thiab kev lis kev cai kom muaj txiaj ntsig zoo los xyuas kom meej sijhawm thiab nyab xeeb rau cov neeg siv khoom thoob ntiaj teb.
Peb Qhov Zoo
Ua raws li kev ua tau zoo thiab FDA tso npe txhawb nqa
Cov khoom yog tsim nyob rau hauv GMP / FDA / CEP certified khub factories. Terlipressin API purity Ntau dua lossis sib npaug li 99.0%, cov ntsuas tau ua tiav raws li Terlipressin FDA pom zoo cov cai. Peb muab cov ntaub ntawv sau npe ua tiav los pab kev npaj tau txais kev pom zoo sai.
Muaj peev xwm tsim tau ruaj khov thiab nyob rau hauv -Tshuaj lav
Peb muaj - daim ntawv cog lus ntev nrog cov thawj coj peptide ntau lawm puag. Terlipressin hauv Tshuag ua rau cov lus teb ceev ceev rau kev txiav txim sai. R&D sim txiav txim pib los ntawm 100mg, thiab kev lag luam ntau lawm txhawb nqa Bulk Terlipressin loj - nplai kev yuav khoom yam tsis muaj kev ncua sijhawm R&D thiab kev tsim khoom.
Pob tshab thiab tsim nyog Terlipressin Nqe
Loj - nplai ntau lawm thiab cov saw hlau ruaj khov ua tiav cov nqi siab. Tus nqi qhib thiab pob tshab uas tsis muaj tus nqi zais, pab cov neeg siv khoom tswj cov nqi zoo.
Mature Ntiaj Teb Export thiab Kev Pabcuam
Peb muaj cov tshuab ua tiav rau kev tshaj tawm kev lis kev cai, tshuaj xyuas, kev xa khoom thiab cov ntaub ntawv, nrog rau kev muag khoom mus rau ntau tshaj 60 lub teb chaws thoob ntiaj teb. Peb muab 7 × 12 teev kev txhawb nqa ntau hom lus, kev pab cuam thiab sai tom qab- kev muag khoom rau kev txhawj xeeb- kev paub dawb.
Saj zawg zog Customization Services
Peb muab cov kev pabcuam Terlipressin customized nrog kho purity, particle loj, ya raws cov ntsiab lus, ntim specifications thiab ntau ntxiv kom tau raws li kev npaj tshwj xeeb thiab R & D yuav tsum tau.
FAQ
Cim npe nrov: Terlipressin FDA, Tuam Tshoj Terlipressin FDA manufacturers, lwm tus neeg, Hoobkas
