Atosiban API CAS 90779-69-4

Atosiban|Atosiban API|Atosiban acetate cGMP ntau lawm|Kev tshawb fawb-Peptide

Xav tau cov khoom zoo Atosiban Acetate API rau kev tsim khoom lossis kev tshaj tawm tshuaj generic? Kev tshawb fawb-Peptide muab cGMP-raws li Atosiban API CAS 90779-69-4 nrog cov txheej txheem paub tab, tswj tsis tau qhov profile, kev txhawb nqa rau Tuam Tshoj-US-EU tshaj tawm thiab ruaj khov khoom. Txais tos tiv tauj peb.

Atosiban, ib qho hluavtaws peptide oxytocin receptor antagonist, yog siv los ncua kev ua haujlwm ua ntej lub sijhawm ua haujlwm thiab yog ib qho ntawm cov khoom siv ntau tshaj plaws hauv kev kho mob. Nws yog ib qho ntawm feem ntau siv contraction inhibitors hauv kev kho mob. Piv nrog rau cov tshuaj beta agonists, atosiban muaj ntau dua niam txiv -fetal kev nyab xeeb profile thiab tau raug pom zoo ua thawj - kab tshuaj los ntawm kev soj ntsuam cov lus qhia hauv ntau lub tebchaws. science-Peptide, nrog ntau dua 20 xyoo ntawm kev paub hauv kev tsim cov peptides, yog ib lub tuam txhab thaum ntxov hauv Suav teb uas tau tsim cov txheej txheem ntawm atosiban APIs. Peb atosiban API tau txais cov khoom lag luam paub tab -theem synthesis txoj hauv kev nrog cov txheej txheem muaj zog thiab cov ntaub ntawv tsis huv, thiab peb tau muab cGMP-ua raws Atosiban API CAS 90779-69-4 rau ntau lub tuam txhab tshuaj hauv tsev thiab txawv teb chaws los txhawb lawv cov qauv tsim thiab kev sau npe generic.

Atosiban (Atosiban Acetate) yog cyclic peptide muaj 9 amino acids .Nws inhibits oxytocin -induced uterine contractions los ntawm kev sib tw khi rau oxytocin receptor, li no prolonging cev xeeb tub thiab yuav lub sij hawm rau fetal lub ntsws maturation thiab transit.

Clear mechanism ntawm kev txiav txim:tshwj xeeb oxytocin receptor antagonist, tsis cuam tshuam nrog lwm cov tshuaj hormones.

Kev nyab xeeb siab:zoo tolerated los ntawm leej niam thiab fetus, ob peb lub plawv mob.

Clinical status:Ua ntej - kab contraction inhibitor pom zoo los ntawm European thiab cov lus qhia hauv tsev rau kev kho mob ntxov ntxov.

Ntau yam ntawm cov ntawv ntau npaum li cas:Feem ntau muab raws li cov kua tshuaj txhaj rau hauv ob qho tib si prefilled syringes thiab multi-dose vials.

Nrog rau kev nthuav dav ntawm kev lag luam tshuaj generic, qhov kev thov rau atosiban APIs txuas ntxiv mus. Siab -zoo, ua raws thiab ruaj khov ntawm APIs tau dhau los ua qhov tseem ceeb ntawm cov tuam txhab tshuaj.

1. Cov kev paub dhau los hauv cov txheej txheem routing thiab scale - nce
Peb tau pib txoj kev txhim kho ntawm atosiban ntau tshaj kaum xyoo dhau los, thiab tom qab ntau qhov kev ua kom zoo, peb tau tsim cov txheej txheem ntawm kev paub tab thiab muaj zog hluavtaws:

• Khoom-theem synthesis: Fmoc solid-theem synthesis lub tswv yim tau txais, thiab kev sib xyaw ntawm cov cob thiab tiv thaiv pab pawg tau ua kom zoo dua qub los txhim kho cov txiaj ntsig ntawm crude peptide.
• Cyclization txheej txheem: Precise tswj ntawm disulfide daim ntawv cog lus tsim cov xwm txheej, zam kev tsis sib haum xeeb thiab kev cuam tshuam sab, ua kom muaj kev ua haujlwm ntawm cyclization.
• Txoj kev purification: Multi-pab npaj HPLC purification, zoo tshem tawm impurities, kom paub tseeb tias cov purity ruaj khov ntawm ntau tshaj 99%.
• Scale- nce ntau lawm: Cov txheej txheem tau ua tiav nce mus txog 100 kilograms, thiab cov ntaub ntawv los ntawm ntau qhov kev siv tau zoo qhia tau tias muaj kev sib luag ntawm cov khoom siv.

2. Kev tswj xyuas nruj, raws li cov qauv cGMP
Peb tsim Atosiban API raws li cGMP cov cai, thiab txhua batch raug soj ntsuam nruj me ntsis:

• Tso Tawm: Cov tsos mob, cov ntsiab lus (Ntau dua lossis sib npaug li 99.0%), purity (HPLC, Ntau dua lossis sib npaug li 99.0%), cov khoom muaj feem xyuam (ib qho impurity Tsawg dua lossis sib npaug li 0.15%), noo noo, cov kuab tshuaj seem, cov kab mob endotoxin, microbial txwv.
• Impurity profile tswj: kev txheeb xyuas cov txheej txheem impurities thiab degradation cov khoom los xyuas kom meej tias cov impurity profile yog raws li cov kev tshawb fawb thawj.
• Cov kev tshawb fawb txog kev ruaj ntseg: Ntev- lub sij hawm, ceev cov ntaub ntawv ruaj ntseg los txhawb lub sij hawm rov ua dua 24 lub hlis.
• Method validation: Txhua txoj kev tshuaj ntsuam xyuas tau raug lees paub kom ua tau raws li cov cai ntawm ICH Q2.

3. Ua kom tiav cov ntaub ntawv sau npe, txhawb kev tshaj tawm ntawm Tuam Tshoj, Tebchaws Asmeskas thiab Europe
Peb paub zoo txog API cov ntaub ntawv yuav tsum tau ua rau cov ntaub ntawv dav dav ntawm Atosiban thiab tuaj yeem muab:

• Txheej txheem kev txhim kho cov ntaub ntawv
• Txheej txheem validation cov kev pab cuam thiab ceeb toom
• Cov txheej txheem analytical validation qhia
• Cov ntaub ntawv kawm ruaj khov
• Heterogeneous Mass Spectrometry Analysis Report
• Cov ntaub ntawv pov thawj ntawm cov qauv (NMR, MS, IR, thiab lwm yam)
• Batch ntau lawm cov ntaub ntawv (ua tiav thiab traceable)
• Kev koom tes nrog cov neeg siv khoom nyob rau hauv - kev tshuaj xyuas qhov chaw los ntawm cov chaw muag tshuaj

4. Txhim khu kev ruaj ntseg cov saw hlau

• Kev yuav khoom dual: cov ntaub ntawv tseem ceeb (amino acids, resins) muaj ntau tshaj ob tus neeg muag khoom tsim nyog.
• Strategic stockpiling: Tsim cov khoom ruaj ntseg rau cov khoom siv sij hawm ntev.
• Kev tsim khoom tas mus li: Ntau cov kab ntau lawm tuaj yeem ua rau tib lub sijhawm kom tsis txhob muaj peev xwm fwj.

5. Cov hom kev sib koom tes yooj yim

• Kev muag khoom ntawm APIs: Muab cGMP-raws li Atosiban APIs los txhawb kev tsim cov kev npaj.
• Kev tso cai DMF: Peb muab DMF daim ntawv tso cai los txhawb cov neeg siv khoom cov ntaub ntawv qhia tshuaj.
• Kev hloov pauv tshuab: Cov txheej txheem tuaj yeem xa mus rau cov neeg siv khoom- cov chaw tsim khoom tshwj xeeb.
• Customized ntim: raws li qhov xav tau ntawm kev npaj, muab cov khoom sib txawv ntawm kev ntim khoom.

• cGMP chaw tsim khoom (10 acres)
• Ua raws li US FDA, Europe EMA, Tuam Tshoj NMPA cGMP cov cai
• ISO 9001: 2015 tau ntawv pov thawj
• Automated khoom theem synthesis cog (100 kg peev)
• Npaj HPLC purification system
• Txias-rhiav kom qhuav (ntau tshaj 30 square meters)
• Qhov chaw huv (ISO chav kawm 7/8)
• Ua kom tiav QC kuaj
• Qhov system zoo
• Kev tswj xyuas nruj, kev tswj kev sib txawv
• Cov neeg muab khoom kuaj xyuas thiab cov khoom siv traceability
• Kev Ntsuam Xyuas Txhua Xyoo
• Koom tes nrog cov neeg siv khoom thiab cov tswj hwm rau ntawm - kev tshuaj xyuas qhov chaw

1. Kev siv tshuab paub tab, ntshiab impurity profile
Peb tau sau ntau tshaj 10 xyoo ntawm kev paub nyob rau hauv zus tau tej cov Atosiban API, thiab peb cov txheej txheem yog tas li optimized, thiab cov impurity profile yog heev zoo raws li cov thawj kev tshawb fawb. Ntau tus neeg muas zaub xaiv peb vim peb cov cuab yeej paub tab thiab tswj tsis tau, kom lawv tuaj yeem siv sijhawm tsawg dua thaum ua ntawv.

2. Kev ua raws cai, uas tuaj yeem tiv taus kev tshuaj xyuas
Peb cov chaw cGMP thiab cov ntaub ntawv pov thawj tau tiv thaiv kev tshuaj xyuas los ntawm cov chaw tswj xyuas tshuaj hauv tsev thiab txawv teb chaws. Cov neeg siv khoom twb tau siv peb Atosiban API kom ua tiav kev soj ntsuam kev sib raug zoo hauv tsev thiab EU ANDA pom zoo.

3. Kev ruaj ntseg ntawm kev muab khoom thiab tsis yog - txiav tawm ntawm cov khoom lag luam
Peb tau tsim kom muaj kev tswj xyuas cov khoom lag luam zoo tshaj plaws, nrog rau ob qho - kev yuav khoom ntawm cov ntaub ntawv tseem ceeb thiab cov tswv yim txaus. Peb tau khaws cov khoom ruaj khov ntawm atosiban APIs txawm tias lub sijhawm tshwj xeeb, thiab tsis tau muaj kev cuam tshuam hauv kev muab khoom.

4. Tshaj tawm kev txhawb nqa, txuag kev siv zog
Qhov peb muab tsis yog API nkaus xwb, tab sis kuj muaj cov ntaub ntawv tiav thiab cov ntaub ntawv los txhawb kev sau npe. Ntau tus neeg siv khoom tawm tswv yim tias peb cov pob khoom muaj txiaj ntsig zoo thiab tuaj yeem siv tam sim ntawd, uas txuag lawv lub sijhawm ntau.

Txawm hais tias koj xav tau Atosiban API rau kev tsim tawm lossis npaj cov tshuaj xa mus, Kev Tshawb Fawb -Peptide tuaj yeem muab cov kev daws teeb meem zoo, ua raws thiab txhim khu kev qha rau koj. Peb pawg kws tshaj lij thiab kev lag luam tos ntsoov yuav ua haujlwm nrog koj.