Lub hauv paus rau phau ntawv
Cov khoom lag luam
#### ** 1. Txheej txheem cej luam **
Sildenafil citrate yog thawj qhov ncauj phosphodiesterase -5 (pde -5) inhibitor tsim los ntawm Pfizer. Nws tau pom zoo los ntawm FDA xyoo 1998 rau kev kho cov txiv neej erectile kawg (ed). Nws API yog ib qho dawb dawb kom tawm-dawb crystalline hmoov nrog siab xaiv thiab ntev-ntev nyhuv, ua ib lub cim nyob rau hauv kev kho mob. Tsis tas li ntawd, nws cov derivatives (xws li Revatio ® tseem siv tau hauv kev kho mob ntawm cov mob ntsws (PAH).
#### ** 2. Tshuaj lom neeg cov khoom lag luam thiab tus lej cas **
1. ** Qiv Qiv Qiv Cim **
- molecular cov mis: C₂₂₂₂₃₀n₆o₄₆s · C₆h₈o₇
- molecular hnyav: 666.7 g / mol
- Cov Txheej Txheem Nrig: muaj pyrazolopyrimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimidimid
2. ** Tus lej Cas **
- Sildenafil puag: 171599-83-0
- Sildenafil citrate: 139755-83-4
3. ** Lub cev nqaij daim tawv thiab tshuaj lom **
- Solubility: soluble me ntsis hauv dej (3.5 mg / ml, 25 degree), yooj yim solub hauv dmo thiab methanol.
- Melting taw tes: {188-190 degree (kev daws teeb meem kub).
- Kev ruaj khov: khaws cia rau hauv tsaus ntuj, p rhiab (zoo pH 3-5).
#### ** 3. Kev txheeb xyuas thiab kev pom zoo **
Raws li daim ntawv thov thiab daim ntawv npaj npaj, Sildenafil API tuaj yeem faib ua cov hauv qab no:
##### ** 1. Kev faib tawm los ntawm indlication **
- ** API rau kev kho mob **
- ** "Cov txiaj ntsig **: Xaiv tau kev txwv tsis pub muaj PDE {1}}, txhim kho tsis muaj kev sib xyaw vasyodation, qhov ncauj ntawm lub ncauj ntawm txog 40%.
- ** DOSAGE **: Cov qauv tsim yog 25-100 mg ntsiav tshuaj, tau zoo nyob rau hauv {2}} feeb.
- ** API rau pah kho (Revatio®) **
- ** Qhov zoo **: txo cov ntshav loog thiab txhim kho tus neeg mob lub zog muaj peev xwm los ntawm kev ua haujlwm ntawm lub zog pde -5.
- ** DOSAGE **: 20 MG ntsiav tshuaj, 3 zaug hauv ib hnub; lossis txhaj tshuaj dosage.
##### ** 2. Kev faib tawm los ntawm kev tsim qauv txheej txheem **
- ** DELFECT cov ntsiav tshuaj API **
- Cov txheej txheem xav tau: Qhov loj me tswj (D90 <50 50 μm) txhawm rau txhim kho kev sib tham.
- ** OFALES ALQUEGRATION KHW / TAM SIM NTAWD DOSAGE DAIM NTAWV API **
- Qhov zoo: Tsis tas yuav nqa dej, haum rau cov neeg mob uas muaj dysphagia.
- ** Nanocrystalline ua qauv API **
- Cov ntsiab lus technical: txhim kho Bioavailability thiab txo cov kev phiv tshuaj tiv thaiv.
##### ** 3. Kev faib tawm los ntawm Purity Qib **
- ** Qib Pharmacopoe qeb (USP / EP / CHJP) **
- Txuj Ci: Purity ntau dua los yog sib npaug rau 99. {0%, ib qho impurity <{}}. 1%.
- ** Customized Synthesis qib **
- Daim ntawv thov: Kev tshawb fawb txuj ci lossis kev tshawb fawb tshwj xeeb, cov cim ua haujlwm (xws li d
#### ** 4. Cov txheej txheem hluavtaws thiab kev nyuaj "
1. ** Txoj kev siv tshuaj synthesis "
- ** {{{{{{{{pentanone yog siv los ua cov khoom siv pib, thiab nws yog synthesized los ntawm kev hws, kev sib tw, thiab lwm yam.
- ** Qhov tseem ceeb intermediates **: pyrazolophyrimidimidegone skeleton (kauj ruam 3), Sulfonamide Pawg Kev Taw Qhia (Kauj Ruam 5).
2. ** Tshuab huv **
- Crystallization optimization: anti-solvent crystallization txoj kev yog siv los tswj cov ntawv crystal (feem ntau polymorph i).
- Chromatographic purification: siv los tshem tawm chiral impurities (xws li R-Isomer).
3. ** Kev txhim kho kev txhim kho ntsuab ntxiv **
- Cov theem theem synthesis: txo kev siv cov organic cov kuab tshuaj thiab nce ntxiv rau ntau tshaj 75%.
- Enzyme catalysis: Hloov cov kab mob lom zem heev thiab txo cov kev thauj khoom.
#### ** 5. Tswjhwm thiab pharmoroia qauv **
1. ** Cov khoom ntsuas tseem ceeb **
- ** Kev txiav txim siab cov ntsiab lus (USP Txuj Ci (USP Txuj Ci: 98. {% {}}}}}}}%).
- ** EGRISURED SPECTRACT **: suav nrog 8 paub impurities xws li n-deletylated khoom thiab epoxides.
- **Dissolution**: paddle method (900 mL pH 4.5 buffer, 30 minutes dissolution> 80%).
2. ** Kawm ruaj khov **
- Kuaj xyuas kom nrawm (4 {{{{}} degree / 75% rh, 6 lub hlis): Kev loj hlob txawv kev loj hlob tsawg dua los yog sib npaug rau 0.5%.
- photostability: yuav tsum ua raws li Ich Q1B cov lus qhia.
#### ** 6. Kev Lag Luam Thoob Ntiaj Teb thiab Kev Tswj Xyuas Ib puag ncig **
- ** Rau cov tuam ntxhab loj ": Pfizer (thawj tshawb fawb), Is Nrias teb Dr. Reddy's, Tuam Tshoj Guangyao pawg, thiab lwm yam.
- ** Cov kev cai tswjfwm **: Yuav tsum ua raws CGMP, Ich Q7, Tuam Tshoj yuav tsum dhau NMPA rau kev kuaj xyuas.
- ** QUSTEN AATOR **: Cov cim patents tau tas sij hawm, thiab cov tshuaj uas muaj cov tshuaj muaj txiaj ntsig hauv ntiaj teb rau ntau tshaj 70%.
- ** ** TXUAS NQE **: API nqe yog li $ 2000-2500 / kg (2023 cov ntaub ntawv).
#### ** 7. Yav Tom Ntej Kev Loj Hlob Tiam no **
1. ** Kev tsim kho cov ntaub ntawv ntau npaum li cas **: kev hloov pauv thaj, kev hloov ua kom muaj kev txhaj tshuaj ntev (xws li PLGA tsom).
2. ** Kev qhia kev nthuav qhia no ntawm Alzheimer tus kab mob thiab cov siab loj ntawm cov roj ntsha edema edement edema.
3. ** Cov txheej txheem tsim kho tshiab **: Flow Flow DisplayStry txhim kho cov synthesis efficiency.
4. ** Biosimilits **: Kev tshawb nrhiav cov kab mob Engineering Engineering Engineesis txoj kev raws li cov thev naus laus zis.
#### ** 8. Cia thiab Tsheb Thauj Khoom Tshwj Xeeb **
- ** QAUV **: Phaj-pov thawj, Airtight, {20-25 degree (ntev ntev); 2-8 degree (zoo dua rau lub sijhawm ntev cia).
- ** ** NTAUB NTAWV **: Ob-txheej aluminium ntawv ci lub hnab ntim nrog nitrogen, ntxiv rau cov neeg sawv cev noo.
- ** TRANE **: Cov kab mob khaub thuas (2-8 degree) yog qhov yuav tsum muaj, zam kev co.
#### ** Xaus **
Cov kev cuam tshuam ntawm Sildenafil Api yog qhov siab, tab sis nws cov kev thov nthuav dav tsav cov txheej txheem tshiab ntawm cov txheej txheem hluav taws xob thiab cov qauv kev siv thev naus laus zis. Nrog rau kev txhim kho cov tshuaj kho mob, nws lub peev xwm hauv kev kho mob tus kheej yuav raug tso tawm ntxiv.
Txhawb nqa txoj kev them nyiaj thiab tiv tauj peb
Txhawb txoj kev them nyiaj
Peb txhawb ntau txoj kev them nyiaj
Tiv Tauj Peb
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Tiv Tauj Peb tam sim no los ntawm email
Cim npe nrov: Cov hmoov nplej dhau los ntawm cov hmoov av (sildenafil citrate) kho erectile kawg li:} {{{{{171599-83-0 chaw tsim khoom, cov chaw tsim khoom, Hoobkas
