PebXenical Raw Khoom Powder (Orlistat API, CAS 96829-58-2)yog tsim nyob rau hauv nruj GMP tej yam kev mob, xasiab purity, zoo ib yam, thiab ruaj khov khoom muaj peev xwmrau thoob ntiaj teb kws tshuaj manufacturers thiab ntxiv hom.
Nrog cov kws tshaj lij pov thawj hauv API ntau lawm thiab xa tawm, peb muab atag nrho ua raws, technically txhawb, thiab scalable mov tovrau cov tuam txhab tsim cov qauv tswj qhov hnyav, rog- thaiv cov tshuaj, thiab tshuaj tiv thaiv- cov khoom siv tshuaj rog. Txawm hais tias koj yog cov chaw tsim tshuaj, cov neeg tsim khoom cog lus, lossis cov khoom lag luam xa tawm, peb cov khoom siv Orlistat ua kom ntseeg tau.txhim khu kev qha kev ua tau zoo, kev tswj hwm kev txhawb nqa, thiab ntev - lub sij hawm muab khoom ruaj khov.
Technical Specifications
|
Parameter |
Specification |
|
Khoom npe |
Orlistat (Xenical Raw Khoom) |
|
CAS Nr |
96829-58-2 |
|
Molecular Formula |
C29H53 NPO 5 |
|
Molecular Luj |
495.73 |
|
Qhov tshwm sim |
Dawb rau tawm -dawb hmoov |
|
Kev ntsuam xyuas (HPLC) |
98.0% – 102.0% |
|
Profile ntawm impurity |
Ua tau raws li USP/EP cov qauv |
|
Residual Solvents |
Ua raws li ICH Q3C |
|
Hnyav Hlau |
Tsawg dua lossis sib npaug li 10 ppm |
|
Poob rau ziab |
Tsawg dua los yog sib npaug li 0.5% |
|
Kev txheeb xyuas |
IR / HPLC ua raws |
|
Particle Loj |
Customizable raws li kev thov |
|
Txee lub neej |
24 hli |
|
Cia |
Txias, qhuav, deb ntawm lub teeb |
Qhov Zoo Tshaj Plaws
High Purity & Pharmaceutical Qib Zoo
Peb cov khoom siv Orlistat yog tsim los ntawm kev siv cov txheej txheem siab tshaj plaws thiab kev ua kom huv huv, kom ntseeg tauhigh assay tus nqi thiab tswj impurity theem, haum rau kev tswj cov tshuaj formulations.
Strong Lipase Inhibition Performance
Orlistat ua raws li ib tugmuaj zog gastrointestinal lipase inhibitor, txo cov kev noj zaub mov muaj roj txaus thiab txhawb nqa kev tswj qhov hnyav ntawm cov khoom tsim.
GMP{0}}Ua raws kev tsim khoom
Ua nyob rau hauv nruj GMP- tswj ib puag ncig kom paub meej:
Batch-rau-batch sib xws
Tag nrho traceability
Regulatory ua raws li kev npaj
Stable Ntiaj teb no Supply Capability
Peb txhawb:
Tsawg R & D kom muaj nuj nqis (10g-100g)
Pilot ntau lawm scale
Cov khoom lag luam ntau (kg-ton theem)
Kev them nyiaj yug cov ntaub ntawv tag nrho
Cov ntaub ntawv muaj xws li:
Certificate of Analysis (COA)
Material Safety Data Sheet (MSDS)
Cov ntaub ntawv ruaj ntseg
Cov ntaub ntawv txhawb nqa kev tswj hwm (DMF muaj nyob rau ntawm kev thov)
Quality Assurance & Regulatory Compliance
Peb ua raws li kev tswj hwm kev tswj hwm nruj nruj:
Raw Material Control
Tsim nyog kev soj ntsuam tus neeg muag khoom upstream
Cov khoom pov thawj tuaj
Hauv -Kev Saib Xyuas Kev Ua Haujlwm Zoo
Cov tshuaj tiv thaiv kab mob
Intermediate purity xeem
Kev Xeem Khoom Kawg
Kev kuaj xyuas HPLC
Impurity profiles
Microbial txwv kev kuaj
Kev Pabcuam Kev Ua Raws Cai Thoob Ntiaj Teb
GMP manufacturing system
ISO-cov ntaub ntawv pov thawj zoo
USP / EP tus qauv muaj peev xwm ua raws
Kev them nyiaj yug DMF cov ntaub ntawv (yeem rau kev tswj cov ntaub ntawv)
