High Purity Sildenafil Citrate Powder API Tus neeg muag khoom|GMP Pharmaceutical Qib
Nyob rau hauv niaj hnub kev lag luam tshuaj muaj kev sib tw heev, nrhiav ibtxhim khu kev qha, siab -purity API tsumNws yog ib qho tseem ceeb los xyuas kom meej cov khoom zoo, kev ua raws cai, thiab ntev - ua lag luam ua tau zoo. PebHigh Purity Sildenafil Citrate hmoovyog tsim nyob rau hauv nruj GMP tej yam kev mob siv advanced synthesis thiab purification technologies, xaZoo sib xws Ntau dua los yog sib npaug rau 99% purity, zoo heev stability, thiab tag nrho ua raws li thoob ntiaj teb cov qauv (USP/EP).
Raws li kev ntseeg siab thoob ntiaj teb cov khoom lag luam, peb txhawb cov kws tsim tshuaj, cov neeg xa khoom, thiab R & D cov koom haum nrogruaj khov khoom, ua tiav cov ntaub ntawv kev, thiab hloov tau yooj yim customization xaiv. Txawm hais tias koj tab tom tsim cov tshuaj generic lossis scaling li ntau lawm, peb sildenafil citrate API xyuas kom meejzoo koj tuaj yeem ntseeg tau thiab kev ua tau zoo koj tuaj yeem tso siab rau.
Technical Specifications
|
Parameter |
Specification |
|
Khoom npe |
Sildenafil Citrate |
|
CAS Nr |
171599-83-0 |
|
Molecular Formula |
C28H38N6O11S |
|
Molecular Luj |
666,7 g / mol |
|
Qhov tshwm sim |
Dawb los yog tawm -dawb crystalline hmoov |
|
Purity (HPLC) |
Ntau dua lossis sib npaug li 99.0% |
|
Poob rau ziab |
Tsawg dua los yog sib npaug li 0.5% |
|
Residue ntawm Ignition |
Tsawg dua lossis sib npaug li 0.1% |
|
Hnyav Hlau |
Tsawg dua lossis sib npaug li 10 ppm |
|
Residual Solvents |
Ua raws li ICH Q3C |
|
Particle Loj |
Customized raws li kev thov |
|
Txee lub neej |
24 hli |
|
Cia |
Khaws rau hauv qhov chaw txias, qhuav, zoo - qhov cua |
Cov txiaj ntsig tseem ceeb ntawm Peb Sildenafil Citrate API
Kev sib tw kom zoo dua
High Purity & Tsawg Impurity Profile
Peb cov khoom tau dhau los ua ntau yam -pab kom huv thiab cov txheej txheem recrystallization kom paub meejTshwj xeeb purity (Ntau dua lossis sib npaug li 99%)thiab nruj impurity tswj, ua tau raws li thoob ntiaj teb cov qauv tshuaj.
01
GMP{0}}Ua raws li kev tsim khoom
Tsim nyob rau hauv aGMP{0}}cov chaw muaj ntawv pov thawj, xyuas kom cov batch-rau-batch sib xws thiab tsim nyog rau kev lag luam tswj.
02
Ua kom tiav cov ntaub ntawv txhawb nqa
Peb muab cov ntaub ntawv qhia txuj ci, suav nrog:
Certificate of Analysis (COA)
Material Safety Data Sheet (MSDS)
Cov ntaub ntawv ruaj ntseg
Kev them nyiaj yug DMF (raws li kev thov)
03
Muaj peev xwm muab khoom muaj zog
Cov qauv muaj (10g-100g)
Pilot-scale ntau lawm
Kev muab khoom ntau rau ntev - daim ntawv cog lus
04
Ntiaj teb no Export Experience
Peb tau ntse muab khoom rau:
North America
Teb chaws Europe
Southeast Asia
Middle East
05
Quality Control System
Kev ua tau zoo yog qhov tseem ceeb ntawm peb cov txheej txheem tsim khoom. Peb cov sildenafil citrate hmoov yog kuaj los ntawm ib tug nruj multi-theem zoo tswj system:
Raw khoom tshuaj xyuas thiab cov khoom tsim nyog
Hauv -kev soj ntsuam zoo
Cov khoom siv zaum kawg kuaj sivHPLC, GC, thiab IR tsom xam
Thib peb-kev txhawb nqa kev xeem (SGS, Intertek)
Txhua batch yog nrog los ntawm cov ncauj lus kom ntxaws COA los xyuas kom meejtraceability thiab ua raws.
Manufacturing Txheej txheem cej luam
Peb cov txheej txheem tsim khoom yog tsim los ua kom muaj txiaj ntsig zoo, purity, thiab sib xws:
Txheej Txheem Flow:
Raw Materials → Chemical Synthesis → Intermediate Purification → Crystallization → Drying → Milling → Quality Testing → Ntim
Txheej txheem Highlights:
Advanced synthesis technology rau siab yield
Tswj crystallization kom pom cov particle loj
Cov txheej txheem tshem tawm impurity nruj
Tag nrho traceable ntau lawm system
Kev tswj hwm & kev ua raws li kev txhawb nqa
Peb nkag siab txog qhov tseem ceeb ntawm kev ua raws cai hauv kev tsim tshuaj. Peb sildenafil citrate API txhawb:
USP / EP cov qauv kev ua raws cai
GMP cov ntaub ntawv tsim khoom
DMF kev pab cuam (yog tias xav tau)
Kev tswj hwm kev sib tham txhawb nqa
