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I-Sodium Stearyl Fumarate (SSF) Pharmaceutical Lubricant | Ukuhambelana okuphezulu kwe-API, Enye indlela kwi-Magnesium Stearate, i-GMP Grade

I-Sodium Stearyl Fumarate (SSF) yethu sisithambisi samayeza esicocekileyo kakhulu esenzelwe ngokukodwa iipilisi kunye neekhaphu. Ngokungafaniyo ne-magnesium stearate, inika ukuhambelana okuhle kwe-API, ukomelela xa itshizwa kakhulu, kwaye ayinampembelelo imbi kwi-bioavailability.Sisithambisi esihlala emanzini, esinganyibilikiyo kakhulu esibonelela ngobunzima obuphezulu bethebhulethi ngamandla alinganayo okucinezelwa kwaye sinciphise impembelelo kwixesha lokuqhekeka.. Ihambelana ne-USP-NF, EP, kunye ne-JP pharmacopoeias kunye nobhaliso lwe-CDE (F20190000009) kunye nenkxaso ye-DMF (38822). Inqanaba lokusetyenziswa elicetyiswayo: 0.5-3% w/w. Ilungele ukucinezelwa ngqo ngesantya esiphezulu, iithebhulethi ezikhupha umoya, kunye neefomyula ezinee-API ezingahambelaniyo

    Ibanga leMithi iSodium Stearyl Fumarate (SSF)

    Isishwankathelo seMveliso

    I-Sodium Stearyl Fumarate (SSF) sisithambisi seyeza esisebenza kakuhle esaziwa ngokubanzi njengendlela engcono kunezithambisi zemveli ezifana ne-magnesium stearate kunye ne-talc.Yityuwa yesodium ye-stearyl fumaric acid, ebonakala njengomgubo ocolekileyo omhlophe ukuya komhlophe oneempawu ze-amphiphilic ezivumela ukuthambisa okusebenzayo kwimida yeepilisi kunye neekhaphu..

    Ubume beMveliso:

    • Igama leKhemikhali:I-Sodium Stearyl Fumarate

    • Inombolo ye-CAS:4070-80-8

    • Inombolo yoBhaliso lwe-CDE:F20190000009

    • Inombolo ye-DMF:38822

    • Ukuthobela i-Pharmacopoeia:I-USP-NF, i-EP, i-JP

    • Ifomula yeMolekyuli:C22H39NaO4

    • Ubunzima beemolekyuli:390.53 g/mol

    Iimpawu eziphambili kunye neenzuzo

    1. Ukuhambelana kwe-API ePhakamileyo

    • Isombulula iingxaki zokuhambelana ezihlala zidibana ne-magnesium stearate

    • Ukungahambisani kwe-API okuxeliweyo kunye ne-magnesium stearate kuquka: i-Azathioprine, i-Cefaclor, i-Cilazapril, i-Clopidogrel, i-Diclofenac, i-Ibuprofen, i-Omeprazole, kunye nezinye ezininzi

    • Ilungele iifomyula apho ukungahambelani kweekhemikhali kuyingxaki

    2. Ukuqina ukuya ekuthambiseni kakhulu

    • Ngokungafaniyo ne-magnesium stearate, i-SSF igcina ukusebenza kwayo nokuba ixesha elide lokuxuba liyancipha.

    • Inika ubulukhuni bethebhulethi kunye nokuqhekeka kwayo ngaphandle kwemiphumo "yokuthambisa kakhulu"

    3. Iimpawu zeTablethi eziphuculweyo

    • Ubulukhuni obuphezulungamandla oxinzelelo alinganayo xa kuthelekiswa nezinye izinto zokuthambisa

    • Impembelelo encinci kwixesha lokuqhekeka- igcina ithebhulethi iqhekeka ngokukhawuleza

    • Akukho mpembelelo imbi kwi-bioavailability- kuqinisekisa ukuba iiprofayili zokukhululwa kweziyobisi zihlala zinjalo

    4. Indalo ethanda amanzi kunye nenyibilikayo kancinci

    • I-lubricant enyibilikayo emanzini – 0.5 mg/100 mL kwi-25°C, inyuke iye kwi-20 g/100 mL kwi-90°C

    • Isiphumo sisiphumo sentsalela ephantsi kwisisombululo, nto leyo eyenza ukuba sibe sifanelekileyoiipilisi ezikhupha umoya

    • Iphucula iiprofayili zokunyibilika kwee-API ezinganyibilikiyo kakuhle

    5. Iipropati Ezintle Zomzimba

    • Indawo ethile yomphezulu:1.2 - 2.0 m²/g (umgangatho oqhelekileyo)

    • i-pH:malunga ne-8.5 (isisombululo samanzi se-10% kwi-90°C)

    • Indawo yokunyibilika:224 – 245°C (ngoDisemba)

    • Ixabiso leSaponification:142.2 – 146.0

    • Umxholo wobumanzi:

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