1. PH tus nqi
Noj 1. thiab ntsuas raws li txoj kev (Appendix VI H ntawm 2010 Pharmacopoeia Part II). Tus nqi pH yuav tsum yog 5.0-8.0.
2. Viscosity
Noj 10.0g ntawm cov khoom no, xam raws li qhuav, ntxiv 90 degree dej kom tag nrho qhov hnyav ntawm tus qauv thiab dej 500.0g, Npaj 2.0% (g / g) ncua, do kom huv si li 10 feeb kom txog thaum cov khoom sib cais tag nrho thiab ntub dej, txias hauv dej khov da dej, txuas ntxiv rau 40 feeb thaum lub caij txias, centrifuge kom tshem tawm npuas, thiab kho. qhov hnyav los ntawm kev ntxiv dej txias yog tias tsim nyog; Siv ib lub tog raj kheej tig viscometer (NDJ-1 hom rau cov qauv nrog viscosity tsawg dua 100 Pa·s, NDJ-8S hom rau cov qauv uas muaj viscosity ntau dua lossis sib npaug li 100 Pa·s, lossis lwm yam tsim nyog thiab tsim nyog viscometers), ntsuas viscosity ntawm 20 degree ± 0.1 degree raws li txoj kev thib ob hauv Appendix VIG ntawm 2010 tsab ntawm Pharmacopoeia. Rau cov qauv nrog viscosity tsawg dua 600 MPa · s, viscosity yuav tsum nyob nruab nrab ntawm 80% thiab 120% ntawm daim ntawv lo viscosity; Rau cov neeg uas muaj cov cim viscosity ntau dua lossis sib npaug ntawm 600mPa · s, viscosity yuav tsum yog 75% mus rau 140% ntawm cov cim viscosity.
3. Cov tshuaj insoluble hauv dej
Noj 1. , ntxiv 300mL dej (yog tias tsim nyog, nce qhov ntim ntawm cov dej kom tsim nyog los xyuas kom meej cov tshuaj lim), thiab do kom huv si. Lim nws los ntawm No. 1 ntsug melting iav crucible qhuav ntawm 105 degree kom qhov hnyav tas li, ntxuav lub beaker nrog dej, ntxuav cov tshuaj ntxuav rau saum toj ntsug melting iav crucible, lim, qhuav ntawm 105 degree kom qhov hnyav tas li, thiab tawm mus. residue tsis ntau tshaj 5mg (0.5%).
4. qhuav poob phaus
Nqa cov khoom no thiab ziab nws ntawm 105 degree rau 2 teev. Kev poob phaus yuav tsum tsis pub tshaj 5.0% (Tshwj xeeb VIII L ntawm 2010 Pharmacopoeia Part II).
5. hlawv residue
Noj 1.0g ntawm cov khoom no thiab tshuaj xyuas raws li txoj cai (Appendix VIII N ntawm 2010 tsab ntawm Pharmacopoeia). Qhov seem seem yuav tsum tsis pub tshaj 1.5%.
6. Cov hlau hnyav
Cov seem tshuav nyob rau hauv cov khoom ntawm ignition residue yuav tsum tau soj ntsuam raws li txoj cai (Appendix VIII H, Txoj Kev 2 ntawm 2010 Pharmacopoeia), thiab cov ntsiab lus ntawm cov hlau hnyav yuav tsum tsis pub tshaj 20 feem ntawm ib lab.
7. Arsenic ntsev
Noj 1.0g ntawm cov khoom no, ntxiv 1.0g ntawm calcium hydroxide, sib tov, ntxiv dej thiab do sib npaug, qhuav, ua ntej siv cov nplaim hluav taws tsawg kom carbonize, ces ignite ntawm 6{{9 }}0 degree kom tag nrho cov tshauv, txias, ntxiv 5mL ntawm hydrochloric acid thiab 23mL dej kom yaj, thiab xyuas raws li txoj kev (Appendix VIII J, Method 1, Pharmacopoeia Part II, 2010), nws yuav tsum tau raws li qhov yuav tsum tau (0.0002 %).
Jul 20, 2024
Hydroxypropyl Methylcellulose Examination
Xa kev nug
