HK Neopharm Limited yog ib qho ntawm feem txhim khu kev qha manufacturers thiab lwm tus neeg ntawm etelcalcetide hydrochloride nyob rau hauv Suav teb, featured los ntawm cov khoom zoo thiab tus nqi zoo. Thov so assured mus yuav etelcalcetide hydrochloride hauv Tshuag ntawm no thiab tau txais cov lus hais los ntawm peb lub hoobkas. Customized xaj yog txais tos.
Etelcalcetide Hydrochloride, tseem hu ua CAS 1334237-71-}6, yog ib tiam tshiab ntawm longacting calcimimetic peptide API, ua ib tug muaj zog agonist ntawm calcium-sensing receptor (CaSR). Nws yog cov khoom siv tseem ceeb rau kev kho mob ntawm theem nrab hyperparathyroidism (SHPT) nyob rau hauv cov neeg laus cov neeg mob uas muaj kab mob raum mob nyob rau hauv hemodialysis.Cov khoom no muaj peev xwm allosterically qhib lub parathyroid calcium-sensing receptor, sai thiab potently inhibit lub synthesis thiab secretion ntawm parathyroid hormone (PTH), tsis muaj mob loj heev gastrointestinal los yog phiv tshuaj. Nws muaj qhov ua tau zoo ntawm PTH ntau dua thiab ua raws li cov neeg mob zoo dua, ua rau nws muaj kev nyab xeeb thiab muaj txiaj ntsig zoo siab peptide raw khoom hauv kev kho mob nephrology endocrine.
Technical Specifications
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Khoom npe |
Etelcalcetide Hydrochloride |
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Synonyms |
Etelcalcetide hydrochloride txhaj |
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Yam ntxwv |
Colorless ntshiab kua |
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CAS Nr |
1334237-71-6 |
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Assay |
Ntau dua los yog sib npaug rau 99.0% (HPLC, Raws li COA) |
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Formula |
C38H73N21O10S2 • xHCl, 4<=x Ntau tshaj los yog sib npaug 5 |
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Pob |
Pob txheej txheem |
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Cia |
Khaws ntawm 2-8 degree |
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Qauv |
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Cov khoom no yog tsim los ntawm cov nplai loj siv cov khoom siv-theem peptide synthesis thev naus laus zis, ua raws li GMP thiab ICH thoob ntiaj teb cov qauv kev tswj hwm zoo thoob plaws hauv cov txheej txheem. Nws nta siab purity, controllable impurities thiab zoo batch - mus rau -batch sib xws. Nws tuaj yeem siv ncaj qha rau hauv kev tsim kho kev txhaj tshuaj, txheej txheem txheej txheem - nce, kev sim tshuaj thiab kev lag luam tsim khoom, muab cov khoom siv ruaj khov thiab ua raws li kev txhawb nqa rau ntiaj teb nephrology kws tshuaj lag luam, CDMO platforms thiab cov chaw tshawb fawb.
Khoom nta
Raws li kev txhaj tshuaj -cov tshuaj calcimimetic tshwj xeeb, Etelcalcetide Hydrochloride tuaj yeem ua kom muaj zog parathyroid CaSR, txo PTH sai sai hauv 30 feeb, nrog rau ntev - kav ntev thiab ruaj khov, tsis xav tau kev tswj hwm qhov ncauj txhua hnub; tsis muaj kev pheej hmoo ntawm kev nce PTH thawj zaug, thiab nws tuaj yeem kho cov calcium thiab phosphorus metabolism tsis zoo, nrog rau PTH ntau dua li cov tshuaj hauv qhov ncauj.
Kev nyab xeeb zoo heev, kev ua siab ntev siab dua: Nws yuav luag tsis muaj qhov tshwm sim ntawm plab hnyuv loj xws li xeev siab thiab ntuav, qhov tshwm sim ntawm qhov tshwm sim tsis zoo tsuas yog 3% ~ 4%, uas ua rau lub sijhawm ntev - kev kho mob siab ntev ntawm cov neeg mob lim ntshav. Lub hom phiaj yog tshwj xeeb, nrog me ntsis cuam tshuam rau lwm cov ntaub so ntswg ntawm tag nrho lub cev, thiab kev pheej hmoo ntawm niam thiab cov hlab plawv yog tswj tau.
Cov txheej txheem peptide paub tab, ruaj khov thiab txhim khu kev qha zoo: Kev siv cov khoom siv -theem peptide synthesis + ntau- theem purification txheej txheem, cov impurities tseem ceeb, cov kuab tshuaj seem thiab cov microbial txwv nruj me ntsis tswj nyob rau hauv cov kev txwv ntawm thoob ntiaj teb pharmacopoeia. Cov ntaub ntawv siv lead ua thiab lub cev thiab tshuaj lom neeg muaj zog, thiab qhov sib txawv ntawm purity thiab potency ntawm batches yog tsawg, ua tau raws li cov kev xav tau ntawm kev lag luam tas mus li.
Adaptable rau kev txhaj tshuaj, ua kom tiav kev txhawb nqa: Tsim tshwj xeeb rau kev txhaj tshuaj, nws muaj qhov zoo solubility thiab compatibility stability, yoog raws cov qauv kev kho mob xws li 0.5mL: 2.5mg, 1mL: 5mg, 2mL: 10mg. Nruab nrog ua tiav COA, cov qauv kev lees paub thiab cov ntaub ntawv ruaj khov, nws txhawb nqa kev sau npe hauv tsev thiab txawv teb chaws thiab kev soj ntsuam zoo ib yam.
Full -Cycle Quality Control & Consistent Quality
Kev ua tau zoo yog qhov kev sib tw tseem ceeb ntawm peb Etelcalcetide Hydrochloride. Peb tau ua tiav kev tswj xyuas qhov zoo los ntawm cov khoom siv raw mus rau cov khoom tiav, kom lav tag nrho cov kev ua raws cai thiab kev nyab xeeb ntawm API:
- Kev tswj xyuas cov khoom siv nruj nruj: Peb xaiv cov kws tshuaj - qib hluavtaws amino acids, txhua tus neeg muab khoom muaj GMP tsim nyog, thiab tsuas yog tom qab kuaj tag nrho thaum nkag tuaj yeem muab tso rau hauv kev tsim khoom.
- Kev tswj cov txheej txheem ntau lawm: Kev tsim khoom yog ua tiav hauv 10,000- theem kev cob qhia huv, nrog kev tswj xyuas meej ntawm cov tshuaj tiv thaiv, purification, lyophilization thiab sub- ntim cov khoom, kev soj ntsuam online hauv lub sijhawm, txhawm rau tshem tawm cov kev hloov pauv.
- Kev tshuaj xyuas tag nrho ntawm cov khoom tiav: Los ntawm ntau qhov kev ntsuam xyuas xws li HPLC, MS, sterility thiab endotoxin, peb muab COA batch los ntawm batch, kom ntseeg tau tias cov ntsiab lus, cov khoom muaj feem xyuam, cov khoom, thiab lwm yam raws li cov qauv EP / USP.
- Kev khaws cia thiab kev thauj mus los lav: Cov saw hlau txias cia thiab kev thauj mus los ntawm 2 ~ 8 degree, nrog lub teeb - pov thawj ntim ntim, tiag - lub sijhawm ntsuas kub thiab av noo thoob plaws hauv cov txheej txheem, los tiv thaiv kev puas tsuaj thiab muaj kuab paug, thiab tswj kev ruaj ntseg ntawm cov khoom lag luam.
- Kev ua kom zoo tsis tu ncua: Peb niaj hnub ua qhov kev tshawb nrhiav kev ruaj ntseg thiab kev tshuaj xyuas cov txheej txheem, hloov kho cov phiaj xwm tswj kom zoo, kom ntseeg tau ntev - Lub sijhawm khoom ruaj khov.
Daim ntawv thov Scenario
Raws li cov khoom siv tseem ceeb rau SHPT kev kho mob, Etelcalcetide Hydrochloride yog siv dav hauv kev lag luam tshuaj R & D, kev tsim kho thiab kev tshawb fawb:
SHPT npaj ntau lawm rau cov neeg mob lim ntshav
Raws li cov ntaub ntawv tseem ceeb rau loj - teev ntau lawm ntawm kev txhaj tshuaj, nws yog tsim rau cov neeg laus hemodialysis, muaj zog inhibiting PTH thiab tiv thaiv cov teeb meem xws li lub raum osteodystrophy thiab vascular calcification.
Generic tshuaj R & D thiab sau npe
Kev ntsuas ntsuas raws li cov qauv kev tshawb fawb thoob ntiaj teb, peb muab siab - cov ntaub ntawv nyoos huv thiab ua tiav cov ntaub ntawv sau npe, pab cov tuam txhab tshuaj ua kom lub voj voog R&D luv luv, txo qis kev pheej hmoo rau kev sau npe, thiab ua kom cov tshuaj muaj txiaj ntsig zoo.
Kev tshawb fawb tshuaj nephrology:
Raws li cov cuab yeej sib xyaw, nws yog siv rau kev tshawb fawb yooj yim xws li kev tswj hwm kev ua haujlwm parathyroid, calcium thiab phosphorus metabolism mechanism, thiab tshuaj ntsuam xyuas tshuaj tshiab, muab kev tshawb fawb tshawb fawb txog kev tshawb fawb ntawm nephrology endocrinology.
Kev koom tes ntawm CDMO/CRO
Peb txhawb nqa tag nrho -cov lus qhia tshwj xeeb los ntawm milligram mus rau kilogram, thiab muab kev kho kom huv si, kev sim thiab kev txhim kho cov txheej txheem, hloov mus rau R&D pilot test, pilot scale-up and commercial production.
Ntim thiab thauj
Txhawm rau kom ruaj khov zoo ntawm cov khoom thaum lub sij hawm tag nrho cov txheej txheem ntawm kev khaws cia thiab kev thauj mus los, peb nruj me ntsis siv cov txheej txheem ntim khoom thiab cov kev daws teeb meem logistics:
Professional sealed ntim:Cov txheej sab hauv yog sterile medicinal aluminium foil hnab, txheej txheej yog siab- tiv taus thiab ya raws- pov thawj nyuaj nruas / vial, nrog ua - nyob rau hauv desiccant, lub teeb - pov thawj, kaw thiab xau- pov thawj, zoo cais cov pa oxygen, noo noo thiab microbial pollution.
Flexible mov ntawm ntau yam specifications:Peb muab kev tshawb fawb tshawb fawb - qib milligram ntim thiab kev lag luam - qib kilogram ntim, uas tuaj yeem ua raws li qhov xav tau.
Lub ntim kom meej meej cim lub npe khoom, batch naj npawb, cia tej yam kev mob thiab hnub tas sij hawm, ua raws li lub ntiaj teb no kws tshuaj raw khoom raws li txoj cai.
Cold chain logistics lav:Tag nrho cov tsheb thauj mus los yog kub - tswj ntawm 2 ~ 8 degree, nruab nrog lub sijhawm tiag tiag - kub thiab av noo traceability system, siv cov khoom ntim tsis zoo, tsis txhob kub siab thiab lub teeb muaj zog, kom ntseeg tau tias cov khoom zoo tsis puas thaum xa khoom. Peb muaj txaus.
Etelcalcetide Hydrochloride hauv Tshuag los txhawb nqa sai, thiab lees txais Bulk Etelcalcetide Hydrochloride xaj kom ua tau raws li cov kev xav tau ntawm cov chaw muag tshuaj thiab cov chaw tshawb fawb.
Peb Qhov Zoo
1. GMP-raws li kev tsim khoom, traceable zoo
Tag nrho cov txheej txheem ua raws li GMP thiab ICH Q7 cov qauv, peb tau tsim kom muaj qhov ua tiav zoo traceability system, cov khoom ua tau raws li cov kev cai thoob ntiaj teb pharmacopoeia, thiab peb tuaj yeem muab cov ntaub ntawv txhawb nqa kev sau npe ua tiav.
2. Leading peptide technology, ruaj khov purity
Peb paub txog cov thev naus laus zis tseem ceeb ntawm kev ua haujlwm ntev -peptide synthesis thiab purification, lub purity yog ruaj khov ntau dua los yog sib npaug li 99.0%, kev tswj tsis huv yog nruj, thiab cov khoom sib xws - rau - batch sib xws yog zoo heev, ua tau raws li cov kev xav tau ntawm siab - kawg kev npaj.
3. Loj - nplai ntau lawm, khoom ruaj khov
Peb muaj lub hauv paus loj hlob peptide ntau lawm, dual - qhov chaw thaub qab ntawm cov ntaub ntawv raw, cov khoom muaj kev ruaj ntseg txaus, uas tuaj yeem teb sai sai rau cov kev xav tau ntawm kev sim ntsuas, ntsuas ntsuas - nce thiab loj batch, tshem tawm cov kev pheej hmoo ntawm kev cuam tshuam cov khoom.
4. Kev pabcuam kev tshaj lij, ua haujlwm puv - txhawb nqa
Peb muaj cov kws tshaj lij peptide npaj thiab sau npe cov kws tshaj lij pab pawg, muab ib qho - nres cov kev pabcuam xws li kev txhim kho tshuaj, kev ua kom zoo dua qub thiab kev taw qhia cov ntaub ntawv sau npe, pab cov neeg siv khoom sai sai txhawb kev ua haujlwm. Peb kuj muab Etelcalcetide Hydrochloride Dawb Qauv rau koj R & D sim. Yog tias koj xav yuav EtelcalcetideHydrochloride, peb tuaj yeem muab Customized Etelcalcetide Hydrochloride cov kev daws teeb meem kom tau raws li koj cov kev xav tau tshwj xeeb.
5. Ntiaj teb no raws li khoom, zoo heev nqi kev ua tau zoo
Cov khoom lag luam ua tau raws li kev xav tau ntawm kev ua lag luam ntawm Tebchaws Europe, Amelikas, Nyiv, Kaus Lim Qab Teb thiab lwm thaj chaw, loj- nplai ntau lawm txo cov nqi, muab cov neeg siv khoom nrog cov nqi siab - cov khoom siv raw cov ntsiab lus.
FAQ
Yog tias koj tab tom nrhiav rau qhov chaw siab -zoo Etelcalcetide Hydrochloride, etelcalcetide hydrochloride txhaj lossis Etelcalcetide raw khoom, thov koj xav tiv tauj peb txhua lub sijhawm rau cov khoom lag luam raug, kev txhawb nqa thiab kho CAS 1334237-716 kev koom tes daws teeb meem!
Cim npe nrov: Etelcalcetide hydrochloride, Tuam Tshoj etelcalcetide hydrochloride manufacturers, lwm tus neeg, Hoobkas
