Khoom Taw Qhia
|
Khoom npe |
Poloxamer 188 |
|
Pharmacopoeia specification ua raws |
USP/EP/ChP |
|
CAS Nr. |
9003-11-6 |
|
Molecular Formula |
H(C2H4O)a(C3H6O)b(C2H4O)aOH |
|
Qhov ntom |
1.2 ± 0.1g / cm3 |
| Flash Point | 160.5 ± 26.5 degree |
|
Boiling Point |
370.7 ± 37.0 degree |
|
Qhov tshwm sim |
Dawb rau me ntsis daj, translucent hmoov |
Poloxamer 188 yog ib qho polyoxyethylene-polyoxypropylene thaiv copolymer-tseem hu ua polyether polyol- thiab ua hauj lwm raws li ib qho tshuaj polymeric excipient. Raws li tsis yog - ionic surfactant, nws muaj cov khoom emulsifying zoo heev thiab muaj kev nyab xeeb zoo; nws tau txais kev saib xyuas tseem ceeb rau nws lub peev xwm kom ruaj khov ntawm cov cell membrane cov qauv tsis xws luag los ntawm ntau yam. Nws belongs rau chav kawm tshiab ntawm polymeric non-ionic surfactants. Poloxamer yog yooj yim soluble hauv dej los yog ethanol; Nws dissolves nyob rau hauv anhydrous ethanol, ethyl acetate, thiab chloroform, tab sis yog xyaum insoluble nyob rau hauv diethyl ether los yog roj av ether, thiab nthuav tawm ib co foaming muaj peev xwm. Lub pH ntawm 2.5% aqueous tov yog li ntawm 5.0 mus rau 7.5, thaum pH rau cov qib txhaj tshuaj yog nyob nruab nrab ntawm 6.0 thiab 7.0. Nws cov kua dej aqueous yog qhov ruaj khov hauv huab cua, txawm tias raug lub teeb ua rau pH txo. Cov khoom tseem nyob ruaj khov nyob rau hauv lub xub ntiag ntawm acidic los yog alkaline aqueous daws thiab hlau ions.
Khoom Specifications
|
Cov khoom kuaj |
Executive Standard |
Kev Xeem |
|
Qhov tshwm sim |
Cov khoom no tsis muaj xim lossis daj daj ntshiab kua. Nws yog heev soluble nyob rau hauv ethanol, kiag li ethanol, los yog ethyl acetate, tab sis xyaum insoluble nyob rau hauv ether los yog roj av ether. |
Cov khoom no tsis muaj xim lossis daj daj ntshiab kua. Nws yog heev soluble nyob rau hauv ethanol, kiag li ethanol, los yog ethyl acetate, tab sis xyaum insoluble nyob rau hauv ether los yog roj av ether. |
|
Kev txheeb xyuas |
Cov yam ntxwv nqus perks yuav tsum tshwm sim ntawm wavenumbers ntawm 1100 ± 10cm, 2860 ± 10cm, thiab 2970 ± 10cm |
Ua raws |
|
pH |
5.0-7.5 |
6.4 |
|
Clarity thiab xim ntawm kev daws |
Ntshiab thiab tsis muaj xim |
Ntshiab thiab tsis muaj xim |
|
Oxyethylene Qhov hnyav,% |
20%-28% (kev xeem thib peb) |
26% |
|
Unsaturation |
NMT 0.034 mmol/g |
0.026 mmol/g |
|
Qhov Nruab Nrab Molecular Luj |
2000-2600 |
2535 |
|
Ethylene Oxide,% |
Tom ntej: Ethylene Oxide NMT 0.0001% |
Ethylene Oxide: Tsis pom muaj |
|
Propylene Oxide,% |
Propylene Oxide NMT 0.0005% |
Propylene Oxide: Tsis pom muaj |
|
1,4-Dioxane,% |
1,4-Dioxane NMT 0.0005% |
1,4-Dioxane: Tsis Muaj Tshuaj Tiv Thaiv |
|
Ethylene Glycol,% |
Ethylene Glycol, NMT 0.01% |
Ethylene Glycol, % Tsis pom muaj |
|
Diethylene Glycol,% |
Diethylene Glycol, NMT 0.01% |
Diethylene Glycol, % Tsis pom muaj |
|
Triethylene Glycol,% |
Triethylene Glycol, NMT 0.01% |
Triethylene Glycol,% 0.002% |
|
Butylated Hydroxytoluene (BHT) |
NMT Cov Nyiaj Tau Los (0.01%) |
0.004% |
|
Moisture |
1.0% NMT |
0.1% |
|
Residue ntawm lgnition |
0.4% NMT |
0.1% |
|
Heavy Hlau, ppm |
NWM 20 |
Ua raws |
|
Arsenic |
Yuav tsum Conformed (0.0002%) |
Ua raws |
|
Microbial txwv |
Tag nrho Aerobic Microbial suav: NMT 100 cfu / g |
Tag nrho Aerobic Microbial suav: ＜10 cfu/g |
|
Tag Nrho Cov Poov Thiab Pwm suav suav: NMT 10cfu/g |
Tag Nrho Cov Poov Thiab Pwm suav suav ＜10 cfu/g |
|
|
Cov qauv yuav tsum ua raws li qhov kev sim rau qhov tsis muaj Staphylococcus Aureus thiab Pseudomonas Aeruginosa (tseem: tsis kuaj pom hauv 1g) |
Tsis muaj Staphylococcus Aureus lossis Pseudomonas Aeruginosa tau kuaj pom hauv 1g ntawm cov qauv. |
Xaus: Passed.Ua raws li cov qauv.
Daim ntawv thov
1. Siv los ua emulsifier, solubilizer, wetting agent, thiab suspension stabilizer rau cov kua hauv qhov ncauj thiab tshuaj pleev;
2. tuaj yeem siv los ua cov txheej yas yas rau kev npaj ntawm qhov ncauj;
3. Siv los ua ib lub hauv paus gel rau cov kua lossis ib nrab - cov khoom npaj.
Kev nyab xeeb thiab khaws cia
Kev nyab xeeb
1. Toxicity: Poloxamer 182 tau dhau los ntawm kev soj ntsuam kev nyab xeeb ntau hauv kev siv tshuaj thiab tshuaj pleev ib ce thiab tsis muaj qhov cuam tshuam loj heev.
2. Irritancy: Tsis yog - khaus tawv nqaij thiab qhov muag.
3. Allergenicity: Tsis muaj kev ua xua tseem ceeb.
4. Kev txwv tsis pub siv: Hauv cov tshuaj formulations, cov tshuaj yuav tsum tau hloov raws li daim ntawv thov tshwj xeeb thiab kev tsim kom tsis txhob siv ntau dhau.
Cia:Nws raug nquahu kom khaws cia ntawm chav tsev kub (15-25 degree) hauv lub thawv kaw kom tsis txhob ya raws thiab kis kab mob.
Exhibition
Cim npe nrov: Tuam Tshoj poloxamer 188 manufacturers, lwm tus neeg, Hoobkas
