HK Neopharm Limited yog ib qho ntawm feem txhim khu kev qha manufacturers thiab lwm tus neeg ntawm glatiramer api nyob rau hauv Suav teb, featured los ntawm cov khoom zoo thiab tus nqi zoo. Thov so assured mus yuav glatiramer api hauv Tshuag ntawm no thiab tau txais cov lus hais los ntawm peb lub hoobkas. Customized xaj yog txais tos.
Glatiramer (CAS 147245-92-9) yog ib qho hluavtaws polypeptide polymer, nrhiav pom thaum lub sijhawm tshawb fawb ntawm Weizmann Institute of Science hauv xyoo 1960. Thaum xub thawj siv hauv cov qauv tsiaj rau ntau yam sclerosis (MS), nws tau dhau los ua tus kws kho mob tseem ceeb rau MS. Ua los ntawm plaub amino acids - L-alanine, L-glutamic acid, L-lysine thiab L-tyrosine - nws yog synthesized los ntawm precisely tswj copolymerization. Kev tiv thaiv chemistry thiab kev lim ntshav siab ua kom huv si kom ua tau raws li cov qauv tshuaj thoob ntiaj teb, nrog rau ib puag ncig tus phooj ywg, tsis muaj kev phom sij.
Technical Specifications
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Khoom npe |
Glatiramer |
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Synonyms |
Glatiramer API, Glatiramer Hmoov |
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Yam ntxwv |
Ib qho dawb rau tawm -dawb lyophilized hmoov |
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CAS Nr |
147245-92-9 |
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Assay |
Ntau dua los yog sib npaug rau 98.0% (HPLC, Raws li COA) |
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Formula |
C25H45N5O13 |
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Pob |
Pob txheej txheem |
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Cia |
Ntev-lub sij hawm: Khaws kom nruj, tiv thaiv los ntawm lub teeb & qhuav; ruaj khov rau 3 xyoos ntawm Tsawg dua lossis sib npaug rau -20℃, 2 xyoos ntawm 2-8℃(tub yees). Luv-lub sij hawm: kaw & lub teeb-tiv thaiv; tuaj yeem khaws cia ntawm 15-25℃(chav kub) txog li 1 lub hlis. Tsis txhob khov / thawing voj voog, khaus lub teeb & kub siab. |
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Qauv |
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Raws li ib qho tshuaj tiv thaiv kab mob, Glatiramer API feem ntau yog qhia rau cov ntaub ntawv rov qab los ntawm ntau yam sclerosis, suav nrog kev kuaj mob cais tawm, rov qab ua dua -remitting thiab nquag MS. Nws ua los ntawm kev sib tw rau MHC II binding thiab inducing anti-cov kab mob tiv thaiv kab mob. Nws ua haujlwm rau cov tuam txhab tshuaj, cov chaw tshawb fawb thiab cov tsev kho mob thoob ntiaj teb rau MS kev tsim tshuaj thiab kev tshawb fawb neuroscience. Khaws ntawm 2-8℃thiab muab tshuaj subcutaneously, nws yog lub hauv paus hauv MS kev kho mob thiab ua kom muaj kev vam meej hauv neuroimmunology.
Khoom nta
Cov khoom no yog cov khoom siv hluavtaws polypeptide cov khoom siv raw khoom, raug copolymerized los ntawm plaub lub ntuj amino acids. Nws zoo nkaus li dawb rau tawm -dawb Glatiramer Powder, nrog purity ntsib cov qauv tshuaj pharmacopoeial, ruaj khov thiab tsis muaj impurities los txhawb kev tswj hwm thoob ntiaj teb rau kev txhim kho MS tshuaj.
Viatris glatiramer acetate yog tsim nyob rau hauv kev sib koom ua ke thoob ntiaj teb zoo system nrog tag nrho txias - saw tswj, kaw thiab lub teeb - pov thawj cia ntawm 2-8 degree, xa cov khoom zoo sib xws rau loj - nplai thiab ntev- lub sij hawm muab rau kev lag luam formulation.
Raws li ib qho tseem ceeb immunomodulatory API, nws ua raws li cov protein hauv myelin nrog zoo -cov ntaub ntawv kho mob tau hais tseg, feem ntau yog rau R&D thiab tsim cov tshuaj MS rov qab. Nws txoj kev nyab xeeb thiab kev ua tau zoo tau raug lees paub los ntawm qhov ntev - cov ntaub ntawv kho mob thiab tau lees paub dav hauv kev lag luam.
Cov khoom qhia zoo heev physicochemical stability thiab compatibility. Nws tuaj yeem khaws cia kaw thiab lub teeb - tiv thaiv ntawm 15-25℃rau luv luv - siv sijhawm, thaum lub sijhawm ntev - khaws cia ntawm 2-8℃yog pom zoo. Txias-thaw cycles raug txwv, txhawb nqa thoob ntiaj teb kev thauj mus los thiab txhim khu kev qha rau cov tuam txhab tshuaj.
Full -Cycle Quality Control & Consistent Quality
Los ntawm kev xaiv cov khoom siv raw mus rau cov khoom tiav tiav, tag nrho - txheej txheem tswj kev ua tau zoo yog siv nrog - sij hawm saib xyuas cov txheej txheem tseem ceeb. Purity, impurities thiab physicochemical ntsuas tau nruj me ntsis tswj xyuas kom txhua batch ntawm Glatiramer ua tau raws li thoob ntiaj teb cov qauv kev lag luam zoo nrog kev ruaj khov thiab txhim khu kev qha.
Viatris glatiramer acetate tso siab rau cov txheej txheem tsim khoom thiab kev tswj kom zoo kom ua tiav cov khoom sib xws hauv kev tsim khoom loj -, txo qhov kev hloov pauv zoo thiab muab cov ntaub ntawv rov qab tau, siab - kev ntseeg siab raw cov ntaub ntawv rau cov neeg siv khoom qis.
Raws li kev lag luam xav tau thiab kev lag luam khoom lag luam, cov khoom lag luam tswj hwm qhov zoo thaum txhawb kev sib tw Glatiramer tus nqi, muab cov nqi ruaj khov thiab cov khoom siv txuas ntxiv mus ntev - cov txiaj ntsig zoo thiab nyiaj txiag rau cov neeg koom tes.
Cov qauv nruj nruj thiab kev tshawb fawb ruaj khov yog ua los saib xyuas cov tsos thiab purity nyob rau hauv ntau yam kev cia khoom. Cov ntsiab lus tswj kev ua tau zoo yog qhov ua tau zoo tsis tu ncua kom muaj kev ruaj khov zoo thoob plaws hauv kev khaws cia, kev thauj mus los thiab kev siv, ua raws li cov qauv kev cai thoob ntiaj teb.
Daim ntawv thov Scenario
Raws li kev siv dav hauv immunomodulatory API, Glatiramer (CAS 147245-92-9) nta ruaj khov zoo thiab pom tseeb cov teebmeem tshuaj, pabcuam kws tshuaj R&D, tsim cov qauv tsim thiab kev tshawb fawb tshawb fawb los txhawb kev lag luam kev loj hlob.
Nws yog tsuas yog siv nyob rau hauv kev tsim cov formulations rau relapsing ntau yam sclerosis, ua hauj lwm raws li ib tug tseem ceeb raw khoom rau subcutaneous txhaj tshuaj los pab txhawb loj-scale manufacturing. Viatris glatiramer acetate yog qhov kev xaiv zoo tshaj plaws rau ntau lub tuam txhab tsim vim nws txoj kev tswj hwm nruj.
Nws yog siv nyob rau hauv kws tshuaj R & D rau cov mis optimization, npaum li cas daim ntawv txhim kho thiab mechanism ntawm kev tshawb fawb ntawm cov tshiab MS tshuaj, muab siab - purity raw cov ntaub ntawv rau cov tsev tshawb fawb los txhawb kev ua hauj lwm nyob rau hauv neuroimmunological kev tshawb fawb.
Nws txhawb nqa cov ntawv sau npe thoob ntiaj teb thiab GMP- ua raws li kev tsim khoom, ua tau raws li cov qauv ntawm ChP, FDA thiab lwm cov tub ceev xwm loj los pab cov tuam txhab lag luam tshuaj kom nthuav dav thoob ntiaj teb kev lag luam nrog cov khoom siv raw khoom ua raws thiab ruaj khov.
Nws haum rau cov chaw muag tshuaj muab kev txhawb nqa nrog kev ntim khoom thiab cov phiaj xwm npaj raws li cov neeg siv khoom xav tau. Nrog kev txhim khu kev qha zoo thiab xa khoom raws sijhawm ntxiv rau tus nqi zoo Glatiramer, nws pab cov neeg koom tes txo cov nqi xa khoom.
Ntim thiab thauj
Raws li kev siv tshuaj API zoo heev, Glatiramer (CAS 147245-92-9) xav tau kev ntim khoom thiab kev thauj mus los kom khaws tau qhov zoo. Kev ntim khoom thiab kev tswj xyuas nruj nruj tau raug coj los ua raws li cov khoom siv physicochemical thiab cov qauv kev lag luam los xyuas kom muaj kev nyab xeeb.
Cov khoom raug muab ntim rau hauv cov zaub mov- qib kws tshuaj aluminium foil hnab, nrog rau sab nrauv tsis muaj dej, lub teeb- pov thawj thiab poob siab- cov thawv tiv thaiv, desiccants thiab cov ntaub ntawv cushioning kom cais cov dej noo, lub teeb thiab lub cev. Viatris glatiramer acetate siv tib lub ntim ntim rau kev nyab xeeb thiab kev thauj mus los.
Cov kev qhia tshwj xeeb tuaj yeem hloov kho, nrog kev xaiv tsis tu ncua ntawm 1g, 5g, 10g ib lub hnab thiab 25kg kaw nruas rau kev txiav txim ntau. Txhua batch tau sau meej meej rau tag nrho traceability, haum rau ntau qhov ntau thiab tsawg.
Kev thauj mus los ua raws li cov qauv txias- cov qauv saw nrog cov tsheb tub yees uas tuav 2-8℃thiab tiag tiag- lub sijhawm ntsuas kub. Kev kub siab, khov thiab kev vibration hnyav yog zam kom khaws cia lub cev ruaj khov thiab kev ncaj ncees ntawm cov khoom.
Kev thauj mus los ua raws li cov cai thoob ntiaj teb kev lag luam logistics, txhawb nqa los ntawm kev ua tiav COA thiab cov ntaub ntawv thauj khoom. Nws sib npaug kev ua tau zoo thiab kev tswj hwm tus nqi, nrog tus nqi tsim nyog Glatiramer kom txo cov neeg siv khoom tag nrho cov khoom siv saw hlau.
Peb Qhov Zoo
Peb muaj cov txheej txheem tsim khoom thiab cov txheej txheem tsim khoom siab heev uas ua kom loj - nplai ntau lawm ntawm Glatiramer API. Txhua tus txheej txheem yog nruj me ntsis tswj los xyuas kom meej purity thiab impurities raws li thoob ntiaj teb cov qauv tshuaj nrog zoo batch sib xws.
Peb muab tag nrho - voj voog tswj kom zoo los ntawm cov khoom siv raw khoom mus rau cov khoom tiav tiav nrog kev saib xyuas tag nrho thiab taug qab. Peb kuj txhawb kev sib tw Glatiramer tus nqi los muab tus nqi- cov khoom siv tau zoo thiab cov nqi koom tes qis dua.
Peb cov kws tshaj lij R & D thiab pab pawg muab kev pabcuam Customized Glatiramer cov kev daws teeb meem suav nrog kev ntim khoom thiab cov phiaj xwm npaj, teb sai sai rau cov lus nug thiab ua kom muaj kev sib koom tes zoo.
Nrog xyoo dhau los ntawm kev lag luam kev lag luam, peb nkag siab txog kev tswj hwm tshuaj thoob ntiaj teb thiab kev xav tau ntawm kev lag luam. Peb muab cov khoom lag luam ua raws li cov chaw muag tshuaj loj thiab tswj xyuas cov khoom lag luam ruaj khov kom ntseeg tau tias nyob rau ntawm - lub sijhawm xa khoom thiab zam cov khoom tsis txaus.
FAQ
Peb muab siab -zoo Glatiramer (CAS 147245-92-9) rau cov neeg siv khoom thoob ntiaj teb nrog cov cuab yeej paub tab, puv - voj voog QC thiab cov khoom lag luam txhim khu kev qha. Tag nrho cov txheej txheem ua raws li cov qauv kev lag luam thoob ntiaj teb kom paub meej cov khoom sib xws, ua tiav cov ntaub ntawv thiab ntawm - lub sijhawm xa khoom. Kev tsom mus rau cov neeg siv khoom, peb muab cov kev daws teeb meem hloov tau yooj yim thiab kev txhawb nqa kev tshaj lij nrog cov nqi ua haujlwm. Peb nrhiav kev koom tes nrog kev koom tes ntev nrog cov tuam txhab tshuaj thiab cov chaw tshawb fawb thoob ntiaj teb txhawm rau txhim kho cov tshuaj hauv neuroimmunology.
Cim npe nrov: Tuam Tshoj glatiramer API manufacturers, lwm tus neeg, Hoobkas
