Sildenafil Raw Khoom

Sildenafil (CAS: 139755-83-2) yog phosphodiesterase-5 (PDE5) inhibitor API nrog cov qauv molecular ntawm C₂₂H₃₀N₆O₄S thiab qhov hnyav molecular ntawm 666.7. Raws li cov khoom tseem ceeb rau kev kho mob erectile kawg (ED) thiab pulmonary hypertension, cov khoom no muaj ib tug purity ntawm ntau tshaj los yog sib npaug rau 99% thiab ua raws li USP / EP cov qauv. Nws yog dav siv nyob rau hauv kev loj hlob ntawm cov ntsiav tshuaj, tshuaj ntsiav, thiab cov ntaub ntawv tshiab npaum li cas.

Purity thiab Cov Ntsiab Lus: Raws li kev txiav txim siab los ntawm HPLC, cov ntsiab lus tseem ceeb yog ntau dua lossis sib npaug li 99.0%, tus neeg tsis huv Tsawg dua lossis sib npaug li 0.1%, thiab tag nrho cov impurities Tsawg dua lossis sib npaug li 0.5%. Nws ua raws li USP 43 thiab EP 10.0 tus qauv.
Lub cev muaj zog: Dawb crystalline hmoov, melting point 187-189℃. Dawb soluble hauv DMSO thiab me ntsis soluble hauv ethanol. Kev Tswjhwm Zoo: Kev txheeb xyuas cov qauv yog ua tiav los ntawm UV-Vis thiab MS cov txheej txheem sib txuas, nrog kev saib xyuas nruj ntawm cov hlau hnyav (tsawg dua lossis sib npaug li 10 ppm), cov kuab tshuaj seem (ua raws li ICH Q3C), thiab cov kev txwv microbial.
Kev ruaj ntseg: txee lub neej: 3 xyoos ntawm 25℃/ 60% RH, khaws cia kaw thiab tiv thaiv lub teeb.

Cov khoom no yog npaj siv cov txheej txheem ntsuab synthesis, siv 4-amino-1-methyl-3-n-propylpyrazole-5-carboxamide ua tus tseem ceeb nruab nrab, los ntawm cov txheej txheem xya-kauj ruam uas muaj bromination, aminolysis, thiab cyclization. Cov txheej txheem innovation muaj xws li:

Hloov cov txheej txheem nitration ib txwm, tshem tawm qhov kev pheej hmoo ntawm kev tawg thiab nce tag nrho cov txiaj ntsig los ntawm 20%;

Siv cov poov tshuaj carbonate es tsis txhob thionyl chloride txo cov khoom siv corrosion thiab cov dej khib nyiab;

Tag nrho cov txheej txheem ua raws li cGMP cov qauv, nrog rau qhov tiag -lub sijhawm saib xyuas online ntawm cov txheej txheem tseem ceeb kom ntseeg tau tias batch-rau-batch sib xws.

Kev ua tau zoo thiab kev ua raws cai
Kev ua tau zoo yog lub hauv paus ntawm txhua yam peb ua. Peb sildenafil API ntau lawm system yog tsim los rau cov qauv nruj tshaj plaws thoob ntiaj teb.

Peb tau tsim kom muaj kev tswj xyuas zoo kom ua tau raws li European thiab Asmeskas cov cai tswj hwm nruj:
Raw Material Procurement: Peb tsuas yog ua haujlwm nrog cov neeg muag khoom tsim nyog (nrog rau kev tshuaj xyuas txhua xyoo) los xyuas kom meej tias cov khoom pib (xws li 4-ethoxybenzoyl chloride) ua raws li EP / USP cov qauv thiab muaj cov ntaub ntawv ua tiav.
Cov Txheej Txheem Ntau Lawm: Peb ua haujlwm hauv Chav D GMP chav huv, siv cov tshuaj siv tshuaj thiab sib xyaw ua ke los tiv thaiv tib neeg kev sib kis. Cov tsis tseem ceeb (kub, siab, lub sij hawm tshuaj tiv thaiv) raug kaw hauv lub sijhawm tiag tiag thiab khaws cia rau tsib xyoos.
Kev sim thiab tso tawm: Txhua pawg tau dhau 12 qhov kev xeem (nrog rau cov kev qhia txog tus kheej, purity, impurities, hnyav hlau, thiab microbial tsom xam) hauv peb ISO 17025- muaj ntawv pov thawj hauv tsev. Tsuas yog cov batch uas dhau txhua qhov kev xeem raug tso tawm.

Kev xa khoom sai thiab kev pabcuam kev lis kev cai Clearance
EU: Kev xa mus rau lub teb chaws Yelemees, Fabkis, UK, thiab lwm lub tebchaws muaj nyob ntawm DHL Freight lossis DB Schenker, nrog lub sijhawm xa khoom nruab nrab ntawm 5-7 hnub ua haujlwm. Peb muab tus lej EORI thiab EU Daim Ntawv Pov Thawj Muag Khoom Dawb (CFS) thiab pab nrog kev lis kev cai.
Teb Chaws Asmeskas: Kev xa mus rau cov nroog xws li Chicago thiab New York muaj nyob ntawm FedEx Freight lossis UPS Supply Chain Solutions. Peb pab nrog FDA ntshuam cov ntaub ntawv thiab muab Daim Ntawv Ceeb Toom Ua Ntej (PN) kev them nyiaj yug.

Cov Qauv Txheej Txheem: Peb cov chaw tsim khoom thiab cov txheej txheem tsim los ua kom tau raws li US FDA, European EMA, EDQM, WHO, thiab lwm lub koom haum tswj hwm loj.

Comprehensive Quality Control: Txhua pawg ntawm cov khoom pib thiab cov khoom nruab nrab yog nruj me ntsis tshuaj xyuas los ntawm qhov chaw. Hauv -kab tswj kev ua tau zoo yog siv thaum lub sijhawm tsim khoom, thiab cov khoom tiav tau raug kuaj xyuas tag nrho.

Kev Tshawb Fawb Kev Ruaj Ntseg: Peb ua cov kev tshawb fawb kev ruaj ntseg txuas ntxiv los txiav txim siab cov khoom lag luam rov qab / txee lub neej thiab muab cov ntaub ntawv tseem ceeb rau koj txoj kev tsim kho.

Traceability: Ua kom tiav batch ntau lawm cov ntaub ntawv kom paub meej tag nrho traceability los ntawm raw khoom mus rau cov khoom tiav.

Peb Txoj Kev Them Nyiaj

 

 

Cim npe nrov: Tuam Tshoj Sildenafil raw cov ntaub ntawv manufacturers, lwm tus neeg