I-Sodium Stearyl Fumarate (SSF) Pharmaceutical Lubricant | Ukuhambisana Okuphezulu kwe-API, Okunye Okungafakwanga ku-Magnesium Stearate, Ibanga le-GMP

I-Sodium Stearyl Fumarate (SSF) yethu iyisithambisi semithi esihlanzekile kakhulu esenzelwe ngqo amaphilisi kanye nama-capsule formulations. Ngokungafani ne-magnesium stearate, inikeza ukuhambisana okuhle kwe-API, ukuqina ekugcobeni ngokweqile, futhi ayinawo umthelela omubi ekutholakaleni kwezinto eziphilayo.. Kuyisithambisi esihlala emanzini, esingancibiliki kalula esihlinzeka ngokuqina okuphezulu kwethebhulethi ngamandla alinganayo okucindezela futhi sinciphise umthelela esikhathini sokuqhekeka.. Ivumelana ne-USP-NF, EP, kanye ne-JP pharmacopoeias ngokubhaliswa kwe-CDE (F20190000009) kanye nokusekelwa kwe-DMF (38822). Izinga lokusetshenziswa elinconywayo: 0.5-3% w/w. Kulungele ukucindezela okuqondile okusheshayo, amaphilisi akhipha umswakama, kanye namafomula anama-API angahambisani

Xhumana nathi

Imininingwane Yomkhiqizo

I-Pharmaceutical Grade Sodium Stearyl Fumarate (SSF)

Ukubuka Konke Komkhiqizo

I-Sodium Stearyl Fumarate (SSF) iyisithambisi semithi esisebenza kahle kakhulu esaziwa kabanzi njengendlela engcono kakhulu kunezithambisi zendabuko ezifana ne-magnesium stearate ne-talc.. Usawoti we-sodium we-stearyl fumaric acid, obonakala njengempuphu emhlophe kuya kwemhlophe ecwebezelayo enezakhiwo ezihlala emanzini ahlukene ezivumela ukuthambisa okusebenzayo kwemingcele yethebhulethi kanye ne-capsule..

Ubunikazi Bomkhiqizo:

Igama Lekhemikhali:I-Sodium Stearyl Fumarate
Inombolo ye-CAS:4070-80-8
Inombolo Yokubhalisa ye-CDE:F20190000009
Inombolo ye-DMF:38822
Ukuthobela Imithetho Ye-Pharmacopoeia:I-USP-NF, i-EP, i-JP
Ifomula Yamamolekyuli:C22H39NaO4
Isisindo sama-molecule:390.53 g/mol

Izici Eziyinhloko Nezinzuzo

1. Ukuhambisana kwe-API Okuphezulu

Ixazulula izinkinga zokuhambisana ezivame ukuhlangana ne-magnesium stearate
Ukungahambisani kwe-API okubikiwe ne-magnesium stearate kufaka phakathi: i-Azathioprine, i-Cefaclor, i-Cilazapril, i-Clopidogrel, i-Diclofenac, i-Ibuprofen, i-Omeprazole, nezinye eziningi
Ilungele ukwakheka lapho ukungahambisani kwamakhemikhali kuyinkinga

2. Ukuqina Kokugcoba Okudlulele

Ngokungafani ne-magnesium stearate, i-SSF igcina ukusebenza kahle ngisho nangesikhathi eside sokuxuba
Inikeza ukuqina kwethebhulethi okuqhubekayo kanye nokuqhekeka ngaphandle kwemiphumela "yokugcoba ngokweqile"

3. Izakhiwo Zethebhulethi Ezithuthukisiwe

Ubulukhuni obuphakemengamandla okucindezela alinganayo uma kuqhathaniswa nezinye izinto zokugcoba
Umthelela omncane esikhathini sokuqhekeka- igcina ukuqhekeka kwethebhulethi ngokushesha
Akukho mphumela omubi ekutholakaleni kwezinto eziphilayo- kuqinisekisa ukuthi amaphrofayili okukhishwa kwezidakamizwa ahlala elungile

4. Imvelo Ethanda Ukuwa kanye Nencibilika Kancane

Igrisi encibilika emanzini – 0.5 mg/100 mL ku-25°C, ikhuphuke ibe ngu-20 g/100 mL ku-90°C
Kuphumela ekuncipheni kwezinsalela ezincane, okwenza kube kuhle kakhuluamaphilisi okushisa
Kuthuthukisa amaphrofayili okuncibilika kwama-API angancibiliki kahle

5. Izakhiwo Ezinhle Kakhulu Zomzimba