Dapoxetine Hydrochloride yog ib qho kev xaiv serotonin reuptake inhibitor synthesized raws li siab -purity active tshuaj muaj nyob rau hauv lub qhov ncauj ntau npaum li cas manufacturing. Optimized los ntawm cov crystallization siab heev thiab tswj purification txoj hauv kev, qhov API no muab cov txiaj ntsig zoo sib xws, cov ntsiab lus morphology, thiab kev tswj xyuas nruj ntawm impurity profiles los txhawb kev tsim cov khoom lag luam hauv qab, kev ua raws cai, thiab cov khoom lag luam scalable.
Cov ntsiab lus tseem ceeb
|
Parameter |
Specification Standard |
Test Method/Note |
|
CAS Registry Number |
129938-20-1 |
Chemical Identity |
|
Molecular Formula |
C21H24FNO * HCl |
Stoichiometric Formula |
|
Molecular Luj |
357,89 g / mol |
Mass per Mole |
|
Qhov tshwm sim |
Dawb rau tawm -dawb crystalline hmoov |
Kev tshuaj xyuas qhov muag |
|
Assay (Dried Basis) |
99.0% rau 101.0% |
HPLC |
|
Cov ntsiab lus dej |
Tsawg dua los yog sib npaug li 0.5% |
Karl Fischer |
|
Residue ntawm Ignition |
Tsawg dua lossis sib npaug li 0.1% |
Pharmacopeial Standard |
|
Specified impurity |
Tsawg dua lossis sib npaug li 0.10% |
Tus neeg siab tshaj |
|
Unspecified impurity |
Tsawg dua lossis sib npaug li 0.05% |
Tus neeg siab tshaj |
|
Tag nrho cov impurities |
Tsawg dua lossis sib npaug li 0.30% |
Kev txwv ntau |
|
Residual Solvents |
ICH Q3C Raws Cai (Ethanol tsawg dua lossis sib npaug ntawm 5000 ppm, Dichloromethane tsawg dua lossis sib npaug li 600 ppm) |
GC Headspace |
Chemical & Functional Yam ntxwv
Solubility & Theem Cwj Pwm
Dawb soluble hauv methanol thiab ethanol; sparingly soluble nyob rau hauv dej, cuam tshuam kev xaiv binder thiab ntub granulation tswv yim.
Polymorphism & Stability
Ib leeg, ruaj khov polymorphic daim ntawv tsim los ntawm validated crystallization tsis tiv thaiv theem transformation thaum lub sij hawm cia thiab compression.
Hygroscopic Performance
Tsawg noo noo affinity nyob rau hauv ambient tej yam kev mob, tiv thaiv caking thiab tswj huab hwm coj nyob rau hauv lub sij hawm siab - sib tov ceev.
Technical Focus & Critical Parameters
Particle Loj Distribution (PSD)
Precision dav hlau-milled kom ua tiav D10 tsawg dua lossis sib npaug li 5 micrometers, D50 nruab nrab ntawm 15 thiab 25 micrometers, thiab D90 tsawg dua lossis sib npaug li 60 micrometers rau kev ua kom zoo dua cov hmoov ntws thiab cov ntsiab lus sib xws.
Chiral Integrity
Synthesized los ntawm stereoselective txoj hauv kev kom ntseeg tau siab enantiomeric tshaj thiab nruj pharmacological fidelity.
Elemental Impurity Tswj
Quantified los ntawm ICP-MS raws li ICH Q3D cov lus qhia, khaws cov hlau hnyav kom nyab xeeb hauv qab cov kab mob toxicological.
Formulation & Txheej txheem kev koom ua ke
Direct Compression Suitability
Optimized siv lead ua cwj pwm txo glidant xav tau thaum txhawb cov ntsiav tshuaj ruaj khov hardness thiab sai disintegration.
Excipient Compatibility
Inert kev sib cuam tshuam profile nrog tus qauv excipients suav nrog microcrystalline cellulose, lactose monohydrate, thiab magnesium stearate.
Dissolution Optimization
Kev tsim cov khoom me me txhawb nqa tam sim ntawd - tso tawm cov ntaub ntawv kom zoo ib yam hauv -vivo bioavailability.
Cov ntawv thov kev lag luam
Tam sim ntawd -Tshuaj ntsiav tshuaj
Qhov tseem ceeb active ingredient rau core qhov ncauj ntsiav tshuaj engineered rau ceev gastrointestinal absorption.
Cov ntaub ntawv soj ntsuam kuaj mob
Muab nyob rau hauv theem- qhov loj me batch tsim nyog rau bioequivalence thiab stability raws tu qauv validation.
Kev Tshawb Fawb Kev Siv Tshuaj
validated active tivthaiv rau siab heev urological txoj kev loj hlob pib.
Quality Assurance & Testing
Cov txheej txheem analytical
Tso tawm siv HPLC, GC-MS, LC-MS/MS, thiab FTIR cov txheej txheem.
Hauv -Kev Saib Xyuas Txheej Txheem
Tiag -lub sij hawm taug qab ntawm cov tshuaj tiv thaiv kinetics, thermal gradients, thiab centrifugation tsis.
Kev siv Traceability
Calibrated tiv thaiv thawj cov qauv tshuaj pharmacopeial los xyuas kom meej cov ntaub ntawv kev ncaj ncees.
Technical Documentation & Regulatory Support
Comprehensive Dossier Deliveables
Muab nrog cov ntaub ntawv ua tiav cov ntaub ntawv pov thawj uas muaj Daim Ntawv Pov Thawj Kev Ntsuam Xyuas rau kev sau npe, tsav, thiab kev lag luam validation batches.
Kev Nyab Xeeb & Kev Txheeb Xyuas Cov Txheej Txheem
suav nrog tag nrho GHS raws li -cov ntaub ntawv kev nyab xeeb cov ntaub ntawv nrog rau cov ncauj lus kom ntxaws Product Specifications, Analytical Methods, thiab Synthesis Routes.
Cov Lus Qhia Txog Kev Ua Raws Cai
Rov qab los ntawm cov ntaub ntawv BSE/TSE- daim ntawv pov thawj pub dawb, Tsis yog -GMO cov lus, thiab cov ntaub ntawv qhia txog kev ua xua.
Ntiaj teb no Regulatory Support
Kev sib koom tes tag nrho rau Drug Master Files thiab Certificate of Suitability xav tau los txhawb nqa cov ntaub ntawv nrog cov thawj coj saib xyuas kev noj qab haus huv thoob ntiaj teb.
Cia & Stability raws tu qauv
Kev Tswj Kub Kub
Khaws ntawm 15 ° C thiab 25 ° C, nrog kev tso cai mus ncig txog 30 ° C.
Kev tiv thaiv ib puag ncig
Muab ntim rau hauv cov dej noo-cov thawv tiv thaiv tiv thaiv los ntawm lub teeb ncaj qha thiab av noo.
Txee lub neej
36-Lub hli rov ntsuas qhov rais tau tsim los ntawm hnub tsim khoom hauv cov ntim tsis tau qhib.
Ntim & Logistics
Thawj Tswj Hwm
Muab ob npaug rau- txheej zaub mov- qib LDPE hnab cua sov- kaw hauv qab nitrogen ntxuav kom tshem tawm oxidation.
Kev tiv thaiv thib ob
High -nruas fiber ntau featuring tamper- pov thawj cov ntsaws ruaj ruaj los tiv thaiv txhua yam thiab lub teeb raug.
Transit Security
Shipped nyob rau hauv kev ruaj ntseg, huab cua- saib xyuas ambient logistics channels.
Cov lus nug nquag
Q: Tus qauv coj mus muag kom muaj nuj nqis yog dab tsi?
A: Muab nyob rau hauv 25 kg fiber nruas configurations, nrog kev cai bulk ntim muaj.
Q: Puas yog cov txheej txheem kuaj tau raug muab rau kev kuaj xyuas?
A: HPLC xeem cov txheej txheem thiab chromatograms muaj nyob rau hauv cov ntaub ntawv pob.
Q: Yuav ua li cas residual solvents tswj?
A: Cov txheej txheem hluavtaws siv Chav Kawm 3 lossis tswj chav kawm 2 cov kuab tshuaj tau txheeb xyuas los ntawm headspace GC.
Q: Lub sij hawm ua kom tiav cov txheej txheem yog dab tsi?
A: Kev txiav txim niaj hnub xa nkoj hauv 10 mus rau 15 hnub ua haujlwm tom qab tau txais kev pom zoo.
Q: Puas yog particle loj faib tau customized?
A: Yog lawm, kev cai dav hlau -milling tsis tuaj yeem siv tau kom tau raws li qhov tshwj xeeb compression profiles.
Cim npe nrov: Tuam Tshoj dapoxetine hydrochloride manufacturers, lwm tus neeg, Hoobkas
