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Sodium Stearyl Fumarate (SSF) Tshuaj Siv Rau Tshuaj | API Siab Sib Xws, Lwm Txoj Hauv Kev Rau Magnesium Stearate, Qib GMP

Peb cov Sodium Stearyl Fumarate (SSF) yog cov roj nplua nyeem tshuaj uas muaj cov khoom huv si uas tsim tshwj xeeb rau cov ntsiav tshuaj thiab cov tshuaj ntsiav. Tsis zoo li magnesium stearate, nws muaj kev sib raug zoo nrog API zoo heev, ruaj khov rau kev siv ntau dhau, thiab tsis muaj kev cuam tshuam tsis zoo rau kev siv tau.Nws yog ib qho hydrophilic, semi-soluble roj nplua nyeem uas muab cov ntsiav tshuaj zoo dua ntawm cov zog sib npaug thiab txo qhov cuam tshuam rau lub sijhawm tawg.Ua raws li USP-NF, EP, thiab JP pharmacopoeias nrog CDE sau npe (F20190000009) thiab DMF txhawb nqa (38822). Qib siv pom zoo: 0.5-3% w/wZoo tagnrho rau kev ceev ceev ncaj qha compression, effervescent ntsiav tshuaj, thiab formulations nrog incompatible APIs

    Tshuaj Qib Sodium Stearyl Fumarate (SSF)

    Txheej Txheem Cej Luam Khoom

    Sodium Stearyl Fumarate (SSF) yog cov roj nplua nyeem ua haujlwm siab uas tau lees paub dav dav tias yog lwm txoj hauv kev zoo dua li cov roj nplua nyeem ib txwm muaj xws li magnesium stearate thiab talc.Nws yog ib qho ntsev sodium ntawm stearyl fumaric acid, tshwm sim ua ib qho dawb mus rau off-white hmoov zoo nrog amphiphilic cov khoom uas ua rau muaj kev nplua zoo hauv cov ntsiav tshuaj thiab cov tshuaj ntsiav formulations..

    Lub Npe Khoom:

    • Lub Npe Tshuaj:Sodium Stearyl Fumarate

    • Tus lej CAS:4070-80-8

    • Tus lej rau npe CDE:F20190000009

    • DMF No.:38822

    • Kev Ua Raws Cai ntawm Pharmacopoeia:USP-NF, EP, JP

    • Cov mis molecular:C22H39NaO4

    • Qhov Hnyav Molecular:390.53 g/mol

    Cov Nta Tseem Ceeb & Cov Txiaj Ntsig

    1. Kev Sib Txuas Zoo Tshaj Plaws API

    • Daws cov teeb meem sib xws uas feem ntau ntsib nrog magnesium stearate

    • Cov tshuaj API tsis sib xws nrog magnesium stearate suav nrog: Azathioprine, Cefaclor, Cilazapril, Clopidogrel, Diclofenac, Ibuprofen, Omeprazole, thiab ntau lwm yam.

    • Zoo tagnrho rau cov qauv uas muaj kev txhawj xeeb txog kev tsis sib haum xeeb ntawm cov tshuaj

    2. Kev Ruaj Ntseg Rau Kev Siv Roj Ntau Dhau

    • Tsis zoo li magnesium stearate, SSF tswj tau kev ua tau zoo txawm tias muaj sijhawm sib tov ntev dua

    • Muab cov ntsiav tshuaj tawv thiab tawg ua tej daim me me yam tsis muaj "kev sib txhuam ntau dhau"

    3. Cov Khoom Siv Tablet Zoo Dua

    • Kev nyuaj siab tshaj plawsntawm cov zog sib npaug sib piv rau lwm cov roj nplua nyeem

    • Tsawg dua qhov cuam tshuam rau lub sijhawm tawg- tswj kev tawg ntawm cov ntsiav tshuaj sai

    • Tsis muaj kev cuam tshuam tsis zoo rau bioavailability- ua kom cov qauv tso tawm tshuaj tseem zoo li qub

    4. Hydrophilic & Semi-Soluble Xwm

    • Cov roj nplua nyeem uas yaj tau hauv dej - 0.5 mg/100 mL ntawm 25°C, nce mus txog 20 g/100 mL ntawm 90°C

    • Cov txiaj ntsig hauv cov khoom seem tsawg hauv cov kua, ua rau nws zoo tagnrho raucov ntsiav tshuaj effervescent

    • Txhim kho cov qauv yaj ntawm cov APIs uas yaj tsis tau zoo

    5. Cov Khoom Siv Lub Cev Zoo Kawg Nkaus

    • Thaj Chaw Nto Tshwj Xeeb:1.2 - 2.0 m²/g (qib txheem)

    • pH:kwv yees li 8.5 (10% kua dej ntawm 90 ° C)

    • Melting Point:224 – 245°C (txo qis)

    • Tus nqi Saponification:142.2 – 146.0

    • Cov ntsiab lus noo noo:

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