Pregnenolone API
Pregnenolone ua raws li qhov tseem ceeb ntawm C21 steroid intermediate synthesized los ntawm kev ua haujlwm nruj, ua lub hauv paus ua ntej rau cov khoom siv tshuaj qis qis thiab cov tshuaj steroidal compound synthesis nrog nruj tswj hwm impurity profiles thiab batch - rau -batch sib xws.
Khoom Specification
|
Parameter |
Specification Standard |
Txoj kev analytical |
|
CAS Nr |
145-13-1 |
Literature/Reference |
|
Molecular Formula |
C21H32O2 |
Stoichiometric suav |
|
Molecular Luj |
316,48 g / mol |
Stoichiometric suav |
|
Assay (Dried Basis) |
Ntau dua lossis sib npaug li 99.0% |
High -Kev Ua Haujlwm Ua Kua Dej Chromatography |
|
Qhov tshwm sim |
Dawb rau tawm -dawb crystalline hmoov |
Kev tshuaj xyuas qhov muag |
|
Melting Point |
190℃rau 193 degree |
Capillary Melting Point |
|
Specific Optical Rotation |
+27.0℃rau +32.0℃(c=1 hauv chloroform) |
Polarimetry |
|
Poob rau ziab |
Tsawg dua lossis sib npaug li 0.5% (105 degree, 3 h) |
Gravimetric Analysis |
|
Tus kheej impurity |
Tsawg dua lossis sib npaug li 0.1% |
High -Kev Ua Haujlwm Ua Kua Dej Chromatography |
|
Tag nrho cov impurities |
Tsawg dua los yog sib npaug li 0.5% |
High -Kev Ua Haujlwm Ua Kua Dej Chromatography |
|
Residual Solvents |
ICH Q3C Raws Cai (Ethanol Tsawg dua lossis sib npaug ntawm 5000 ppm, Toluene Tsawg dua lossis sib npaug rau 890 ppm) |
Gas Chromatography |
|
Hnyav Hlau |
Tsawg dua lossis sib npaug li 10 ppm |
Inductively Coupled Plasma Mass Spectrometry |
Chemical & Functional Profile
Steroid Core Reactivity
Muaj ib pab pawg 3 -hydroxy thiab Δ5,6 ob daim ntawv cog lus, ua kom muaj kev xaiv oxidation thiab isomerization thaum lub sij hawm downstream hormone synthesis.
Crystallinity & Particle Loj Distribution
Tswj polymorph profile tiv thaiv agglomeration, kom ntseeg tau tias qhov kev sib cais ntawm cov kinetics thiab cov stoichiometric sib piv hauv cov nqi hluav taws xob.
Stereochemical kev ncaj ncees
Tuav cov kev taw qhia meej meej ntawm cov chaw chiral C3, C8, C9, C10, C13, C14, thiab C17, tiv thaiv kev tsim cov stereoisomeric byproduct tsim nyob rau hauv ntau- kauj ruam synthesis.
Cov khoom lag luam -Kev tsom xam tshwj xeeb
Synthetic Route Control
Muab los ntawm cov tshuaj sterol purified precursors siv txoj kev degradation validated, tshem tawm cov tsiaj - tau txais kev pheej hmoo kis kab mob thiab ua kom tag nrho traceability.
Hnyav Hlau Mitigation
Purified los ntawm ntau-theem crystallization siv tsis yog-chlorinated hnyav tshuab, kom ntseeg tau tias cov hlau hnyav seem nyob qis dua 10 ppm tag nrho.
Thermal stability
Cov khoom pov thawj ruaj khov decomposition pib mus txog 220 degree, lees paub cov txheej txheem robustness raws li tus qauv kev lag luam ziab thiab cov tshuaj tiv thaiv pib kub.
Formulation & Development Considerations
Solubility Profile
Xyaum insoluble hauv dej; soluble hauv kub ethanol, methanol, acetone, thiab chloroform; sparingly soluble hauv diethyl ether.
Reagent Compatibility
Tau tshaj tus qauv oxidizing tus neeg sawv cev thaum hloov 3-hydroxyl pawg mus rau 3-ketone nruab nrab.
Hygroscopic Tendency
Qhia hygroscopicity tsawg nyob rau hauv ib puag ncig warehouse tej yam kev mob, tab sis yuav tsum tau ntim cov ya raws - thaiv thaiv kom tsis txhob ntev - ib puag ncig degradation.
Tej kev siv
API Synthesis Precursor
Ua hauj lwm los ua cov khoom pib pib rau kev tsim cov tshuaj progesterone, cortisone derivatives, thiab steroidal qhov ncauj contraceptive intermediates.
Tshwj xeeb Chemical Intermediates
Siv nyob rau hauv kev cai organic synthesis txoj kev xav tau ib tug nruj cyclopentanoperhydrophenanthrene nplhaib system.
Reference Standard Production
Ua haujlwm siab -purity analytical reference material rau chromatographic method validation in pharmacopeial testing laboratories.
Kev Tswj Xyuas Zoo
Analytical Instrumentation
Assayed ntawm High-Kev Ua Haujlwm Liquid Chromatography nrog UV kuaj pom; Cov qauv kev pom zoo tau lees paub los ntawm Fourier-Kev hloov pauv Infrared Spectroscopy thiab Proton Nuclear Sib Nqus Resonance.
Hauv -Kev Saib Xyuas Txheej Txheem
Tiag -time gas chromatography taug qab cov tshuaj tiv thaiv kev hloov pauv thaum lub sij hawm nruab nrab crystallization thiab hnyav stripping theem.
Batch Release Criteria
Txhua qhov kev lag luam batch raug cais tawm mus txog thaum kawg kev tshuaj ntsuam xyuas ua tau raws li cov kev qhia tshwj xeeb sab hauv thiab cov kev xav tau zoo, txhawb nqa los ntawm dual-tus neeg kuaj kos npe- tawm.
Technical Documentation & Dossier Support
Cov pob khoom tsom xam
Cov ntawv pov thawj ntawm Kev Tshawb Fawb suav nrog kev sau npe, tsav tsheb, thiab cov khoom siv pov thawj kev lag luam, nrog rau tag nrho GHS-cov ntaub ntawv kev nyab xeeb ua raws.
Txheej txheem & Specification Data
Cov ncauj lus kom ntxaws txog cov khoom lag luam, cov txheej txheem kev soj ntsuam tau raug cai, thiab qhov tsis huv -profile- tswj txoj hauv kev ntawm Synthesis.
Cov Lus Qhia
Verified BSE/TSE-dawb daim ntawv pov thawj, tsis yog-GMO tshaj tawm, thiab allergen- cov ntaub ntawv pub dawb.
DMF & CEP Coordination
Kev them nyiaj yug rau cov ntaub ntawv tswj hwm suav nrog Cov Ntaub Ntawv Tshuaj Yeeb Tshuaj thiab Cov Ntawv Pov Thawj ntawm Kev Tsim Kho kom haum raws li cov kev cai thoob ntiaj teb kev cai.
Kev cia khoom
Qhov kub thiab txias
Khaws ntawm 15℃thiab 25℃nyob rau hauv qhuav, tsaus, thiab zoo -ventilated quarantine los yog pom zoo raw khoom warehouse.
Container Integrity
Khaws cov thawv kaw kom nruj thaum tsis siv los tiv thaiv atmospheric noo noo ingress thiab particulate contamination.
Txee lub neej
Ua kom muaj tshuaj lom neeg ruaj khov thiab tau teev cov kev ntsuas ntsuas rau 36 lub hlis txij li hnub tsim khoom thaum khaws cia hauv cov xwm txheej tshwj xeeb.
Ntim thiab Logistics
Ntim Ntim
Muab ob npaug rau- txheej zaub mov- qib qis- hnab polyethylene ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom ntom hnab ntim khoom noj khoom haus ob chav
Kev ntim khoom thib ob
Rigid fiber nruas nrog tamper- pom tseeb xauv lub nplhaib thiab cov hnab ntim desiccant muab tso rau ntawm sab hauv thiab sab nraud.
Standard Export Unit
25 kg net hnyav ib nruas; customized 1 kg mus rau 5 kg ntim xaiv muaj rau R & D ntsuas ntsuas.
Kev thauj mus los
Shipped nyob rau hauv tsis yog - tshuaj lom neeg muaj kev nyab xeeb kev faib tawm ntawm huab cua- saib xyuas cov khoom thauj, tiv thaiv cov khoom los ntawm huab cua hloov pauv thaum caij tsheb npav.
Cov lus nug nquag
Q: Dab tsi yog qhov tsawg kawg nkaus txiav txim kom muaj nuj nqis rau kev soj ntsuam kev lag luam?
A: Tus qauv qauv loj rau kev kuaj kev tsim nyog yog 100 g rau 1 kg, thaum kev lag luam - nplai qhov tsawg kawg nkaus txiav txim kom muaj nuj nqis pib ntawm 25 kg.
Q: Puas yog tsiaj- cov khoom siv los ntawm kev tsim khoom?
A: Cov txheej txheem tsim khoom siv cov nroj tsuag - muab phytosterol pib cov ntaub ntawv, txhawb nqa BSE/TSE- cov ntaub ntawv dawb.
Q: Cov ntaub ntawv txheeb xyuas dab tsi yog muab ua ntej xa khoom xa tuaj?
A: Daim ntawv pov thawj ua ntej xa khoom xa tuaj ntawm Kev Ntsuas uas muaj cov ntaub ntawv ua tiav chromatographic purity, melting point, thiab residual solvent value yog muab rau kev tshuaj xyuas.
Q: Yuav ua li cas cov kev cai particle loj yuav tsum tau tuav?
A: Mechanical micronization lossis dav hlau -milling tuaj yeem npaj tau raws li qhov kev thov kom ua tau raws li qhov xav tau ntawm kev sib cais thiab kev sib cais.
Cim npe nrov: Tuam Tshoj Pregnenolone manufacturers, lwm tus neeg, Hoobkas
