| Khoom npe | Apremilast hmoov |
| Tshuaj npe | (S)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione |
| Synonym | CC-10004 |
| Kev Ntsuas (Purity) | Ntau dua lossis sib npaug li 99.0% |
| CAS Nr | 608141‑41‑9 |
| Molecular Formula | C22H24N2O7S |
| Qhov tshwm sim | Dawb mus rau dawb crystalline hmoov |
| Solubility | Soluble hauv acetonitrile, acetone; me ntsis soluble hauv methanol / ethanol; xyaum insoluble hauv dej |
| Daim ntawv pov thawj | FDA, GMP, ISO, MSDS |
| Kev cia khoom | kaw, tiv thaiv los ntawm lub teeb, 15-25 degree, txias qhov chaw qhuav, tsis txhob khov-thaw mus |
| Muaj Ntim | 100 g / 500 g / 1 kg / 5 kg / 25 kg kws tshuaj aluminium-foil / HDPE nruas |
| Txee-Lub neej | 24 Lub Hlis |
Khoom Description
Apremilast API yog dab tsi?
Apremilast API (CAS 608141-41-9, npe CC-10004)active pharmaceutical ingredient (tshuaj tshuaj)ntawm thawj hom tshuaj Otezla. Nws yog ib qho me me-molecule, xaiv phosphodiesterase-4 (PDE4) inhibitor tsim los rau kev tsim tshuaj thiab kev tsim tshuaj.Chemically, Apremilast yog (S)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminois, hnyav. 460.50 g / mol. Nws zoo nkaus li dawb-rau-tawm-dawb crystalline hmoov, nrog dej solubility tsawg thiab me ntsis hygroscopicity, yuav tsum tau kaw txias-qhuav cia tej yam kev mob.
Xi'an Tongze tuaj yeem muab lwm yam Pharmaceutical-Qib API portfolios.
| Khoom npe | CAS Nr. | Qib & Kev Siv Tau Zoo |
| Apremilast API | 608141‑41‑9 | Pharm Qib: Ntau dua lossis sib npaug ntawm 99.0% HPLC; |
| Roflumilast API | 162408‑66‑4 | Pharm Qib: Ntau dua lossis sib npaug ntawm 99.0% HPLC; |
| Crisaborole API | 906673‑24‑3 | Pharm Qib: Ntau dua lossis sib npaug ntawm 99.0% HPLC; |
| Upadacitinib API | 1708997‑43‑6 | Pharm Qib: Ntau dua lossis sib npaug ntawm 99.0% HPLC; |
| Delgocitinib API | 1263774‑59‑9 | Pharm Qib: Ntau dua lossis sib npaug ntawm 99.0% HPLC; |
| Tapinarof (Benvitimod) API | 79338‑84‑4 | Pharm Qib: Ntau dua lossis sib npaug ntawm 99.0% HPLC; |
| Tazarotene API | 118292‑40‑3 | Pharm Qib: Ntau dua lossis sib npaug ntawm 99.0% HPLC; |
Daim ntawv thov ntawm High-Purity Apremilast API
1. Daim ntawv thov tseem ceeb - Cov khoom siv kho mob rau cov kab mob o
Kev kho cov kab mob inflammatory sawv cev rau kev tsim thiab kev lag luam muaj txiaj ntsig zoo tshaj plaws rau kev ua siab dawb huv Apremilast API. Raws li cov tshuaj yeeb tshuaj, nws ua hauj lwm raws li lub hauv paus raw cov tswv yim rau tiav cov tshuaj noj cov ntaub ntawv.
Kev pom zoo kho mob qhia rau tus neeg pib ua tiav cov tshuaj muaj xws li mob caj dab psoriatic thiab plaque psoriasis, nrog rau cov kab mob hauv qhov ncauj nrog rau Behçet tus kab mob.
2. Cov ntawv thov kev tshawb fawb-Oriented
2.1 Pharmacological Mechanism Research
High-purity Apremilast yog dav siv los ua cov cuab yeej tshawb fawb rau kev tshawb nrhiav PDE-4-targeted inflammatory pathways. Nws txhawb nqa in-vitro enzyme-theem kev soj ntsuam, kev tshawb fawb cytokine-modulation, thiab in-vivo tsiaj- qauv kev sim los tshawb xyuas cov txheej txheem pathological ntawm inflammatory thiab autoimmune disorders. Txhim khu kev ntseeg siab-purity cov ntaub ntawv pab kom tsis txhob muaj cov ntaub ntawv sib txawv los ntawm cov impurities tsis paub thaum lub sij hawm tshawb nrhiav.
2.2 Kev Tswj Xyuas Zoo & Kev Siv-Txheej Txheem Lub Hom Phiaj
High-purity Apremilast (Ntau dua lossis sib npaug li 98.0%, txawm tias mus txog 99.95%) tuaj yeem siv los ua cov ntaub ntawv siv tus qauv. Tej yam xwm txheej muaj xws li:
Kev tswj kom zoo thaum lub sij hawm generic-tshuaj R & D thiab tiav-formulation manufacturing
HPLC system-suitability testing
Analytical-method validation rau kev tswj cov ntaub ntawv xa
High-purity siv cov ntaub ntawv lees paub qhov tseeb, rov ua dua cov txiaj ntsig rau QC lub chaw soj nstuam ntawm cov tuam txhab tshuaj thiab CDMOs.
2.3 Synthetic-Process Development
Kev siv thev naus laus zis yog qhov tseem ceeb rau Apremilast API ntau lawm. Patent-documented recrystallization txheej txheem tuaj yeem nce enantiomeric tshaj (ee tus nqi) mus txog 99.95%, uas yog cov thev naus laus zis thev naus laus zis kom ruaj ntseg siab-purity thiab cov tshuaj siv tshuaj zoo.
Optimized purification workflows ncaj qha cuam tshuam rau impurity profile, raug nqi-efficiency thiab ruaj khov loj-batch muaj peev xwm. Qhov no technical feature.
Kev cuam tshuam ntawm High-Purity API ntawm Down-stream Pharmacological Performance
Rau cov phiaj xwm kev lag luam, API qhov zoo cuam tshuam ncaj qha rau kev ua haujlwm tshuaj ntawm cov ntawv siv tshuaj zaum kawg:
High-purity Apremilast nrog nruj-tswj chiral impurity (R-enantiomer) ua kom cov hom phiaj-inhibitory ua batch-to-batch. Lub R-isomer nthuav tawm tsis muaj zog PDE-4 inhibition kev ua haujlwmOtezla® Nws....
Cov khoom siv qib qis uas nqa cov khoom tsis zoo uas tsis paub meej yuav qhia txog kev ua haujlwm tsis zoo ntawm lub hom phiaj, cuam tshuam nrog kev nyeem ntawv soj ntsuam ua ntej, lossis ua rau muaj kev pheej hmoo tsis txaus siab rau cov tshuaj tiav.
Tias yog vim li cas cGMP-qib high-purity Apremilast (Ntau dua lossis sib npaug rau 99.0% HPLC, tswj hwm tus nqi) yog xav tau rau kev lag luam generic thiab soj ntsuam-sim cov khoom siv. Kev tshawb fawb-qib hmoov tsuas yog haum rau kev kuaj xyuas thaum ntxov.
Cov Lus Qhia Tseem Ceeb
Apremilast API yog cov khoom siv tshuaj nquag, tsis yog tshuaj tiav. Nws yuav tsum tau ua tiav rau hauv cov ntawv ua tiav tiav los ntawm cov chaw tsim tshuaj muaj ntawv tso cai ua ntej tib neeg siv.
Peb tsuas yog muab tshuaj-cov khoom raw-cov ntaub ntawv; peb tsis muab cov lus qhia txog kev kho mob.
Txhua nqe lus hais txog kev kho mob saum toj no yog siv los ntawm pej xeem cov ntaub ntawv tswj hwm tshuaj rau R&D siv nkaus xwb.
Ntim
| Hom kev txiav txim | Net nyhav | Ntim Ntim | Ntim Ntim |
| Qauv / Lab R & D | 100 g, 500 g | Vacuum-sealed multi-layer aluminium-foil barrier bag | Aluminium-foil hnab muab tso rau hauv lub thawv ntawv nrog kev poob siab-absorbing muab tub lim |
| Small-batch lag luam | 1 kg, 5 kg | Ob-txheej nqus tsev vacuum-sealed aluminium-foil hnab nrog desiccant | Pharmaceutical HDPE nruas / fiber nruas |
| Kev lag luam loj loj | 25 kg | Ob txheej txheej aluminium-foil liner + desiccant sab hauv | UN-qualified kws tshuaj fiber nruas |
Cov lus teb rau cov neeg siv khoom
Hu rau nplooj ntawv
High-purity Apremilast API (CAS:608141-41-9) yog cov tshuaj tswj hwm tshuaj. Koj tuaj yeem muab nws los ntawm cGMP-raws li API cov tuam txhab, cov chaw muag tshuaj tsom mus rau thiab cov kws tshaj lij pharma B2B platforms.
Nco tseg: Cov neeg muab tshuaj lom neeg feem ntau tsuas yog muab cov ntaub ntawv tshawb fawb, uas tsis tuaj yeem siv rau kev lag luam tshuaj lossis kev sim tshuaj. Ua ntej kev yuav khoom, thov lees paub cov khoom qib, ICH-raws li kev qhia tshwj xeeb thiab cov ntaub ntawv txhawb nqa tag nrho suav nrog COA, SDS, impurity profile.
Yog tias koj xav tau cov qauv lossis kev txiav txim ntau ntawm high-purity Apremilast API, thov koj xav tiv tauj peb rau daim ntawv qhia tshwj xeeb thiab cov lus hais.
1.Nrhiav txoj kev:
Email: alice@xaheshun.com
whatspp: +8618509260106
Online instant messaging
2. Hu rau cov ntaub ntawv:
Lub npe: Alice
Xov tooj: +8618509260106
Email: alice@xaheshun.com
FAQ
Q: Qhov txawv ntawm cov tshuaj-qib thiab kev tshawb fawb-qib Apremilast API yog dab tsi?
A: Pharmaceutical-qib (Ntau dua lossis sib npaug ntawm 99.0% HPLC) ua raws li ICH Q7 / ICH Q3A, nruj me ntsis tswj chiral enantiomer thiab impurities, haum rau cov tshuaj siv tshuaj thiab cov khoom siv kho mob. Kev tshawb fawb-qib (Ntau dua lossis sib npaug li 98.0% HPLC) tau tso tseg cov kev txwv tsis huv, tsuas yog rau kev kuaj sim, tsis tuaj yeem siv rau tib neeg cov haujlwm ua lag luam.
Q: Cov ntaub ntawv dab tsi koj tuaj yeem muab rau Apremilast API?
A: Batch-specific COA, SDS/MSDS, HPLC chromatogram, impurity profile thiab txoj kev tsom xam. Peb tsis muaj tus lej CEP / DMF uas twb muaj lawm, tab sis muab kev txhawb nqa rau cov neeg siv khoom cov ntaub ntawv tswj hwm kev npaj.
Q: Qhov kev cia khoom dab tsi Apremilast API xav tau?
A: Khaws kaw ntawm 15-25 degree, txias qhuav thiab tiv thaiv los ntawm lub teeb; me ntsis hygroscopic. Txee lub neej yog 3 xyoos nyob rau hauv cov khoom qub qub.
Q: Cov ntawv thov tseem ceeb ntawm Apremilast API yog dab tsi?
A: Feem ntau yog cov tshuaj yeeb tshuaj rau qhov ncauj generic ntsiav tshuaj rau cov kab mob inflammatory; kuj tseem rau kev tsim kho, kev tsim khoom siv tshuaj kho mob, kev tshawb fawb ua ntej kws kho mob thiab QC siv cov qauv qauv. Nws yog raw khoom nkaus xwb, tsis tiav tshuaj.
Q: Dab tsi ntim khoom siv rau Apremilast API?
A: Lub teeb-pov thawj & noo-pov thawj lub tshuab nqus tsev ob-txheej aluminium-foil puab hnab nrog desiccant; Cov khoom ntim sab nraud: thawv rau cov qauv, HDPE / UN-certified fiber nruas rau kev txiav txim ntau. Standard loj: 100 g, 500 g, 1 kg, 5 kg, 25 kg.
Cim npe nrov: Tuam Tshoj high-purity apremilast api (cas 608141-41-9) manufacturers, lwm tus neeg, Hoobkas
