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    LAMPIRAN

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    LAMPIRAN

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    © All Rights Reserved
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    1 views18 pages

    2

    Uploaded by

    SriWahyuniIlanunu
    LAMPIRAN

    Copyright:

    © All Rights Reserved
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    of 18
    y Bl Hrpromeliose 1 Monproprictary Nemes 5 stectural Formule Snetpromatace 2 armen Saeco eae {Dikpw hse . here Rin, CHior CHOMOHICH: Functional Category 3 chemise Nama end CAS Ragery Number Sonat macnn st, aie Cotabae depron eer tN 3] 4 emntcttonmiaandsaiei wight 7 legen m Phere Fermaatin or Bape cpa eats roan ey ed orphan aa nd Sean eee coder comets ae AS Pope math primary ced ato abi Snes he SE 5cs sintin ns_S : Se as/7 ~O@le= lim © 1 Rypicel Prepertion idiniathalintry pH = 3.0-8.0 for 9 2% whw aqueous schation. dees erceure 360°C Bade (iets 8 Sat goers heir (eupepedt) OS 3S wie fare (erway “1 326 gic Wining point Brows at 190-200°C chars at 22.5-230°C. Glass teanaitiom temperature te 1 20—1 #0 MERITS SRT peo thcllows sbegriy sroiscure from the acmo- fioistare content and the torspersture and relarive burnidiey Of the surrounding aie See Figure 1 pS oegh ga Gglation: practically inavlutyle im her waren chlorgrorm, cn PSSSEN ARG crhen” Bue’ Soluble "in Tiigeures oF ethanol and Sichiocomedhane. imintsres Gf mettanal aad dichiorsmerhaacs Sha Sustires oF warer and alcohol Cercain geaden OF hypro Gihiscomatianc and prdpan2ot and. coher anpant esheets: Some grades are swelldblie in crhanol. "See also Section Vie sorpie geaetty 1 2e SEoartgh Cafpiacionnae) (A wide range of viscosity types are commercially available. RGcecas Sotinicns are mae contmoaly prepare, athaueh iypeomelione may also be dieecived in aqueous alebivals euch SE RINSO SSS Bhopaa te St prided The" Sar Sonne faay aise be used to prepare viscous hypromeligee solusans: SGiitions preparcd Using organic solvents tend to be more ease: ieGrehelie coacenteseicn alsa produces more wiesoue To prepare an squcous solution, if ig recommended thar hypcbmaliges is diseraed aad tharsughly lnpdeated tn sboue BBESOSS ofthe required amouncof wares The water should fe waged Sainsas gancd tecannes tes BOSONS werel them cate: bypromellors shoul be added. The bear source can be S Sls =] sco = i SS SSS = a Rien ae @iB S| teat 178 1000 « [2nd deri iz 02 “Tigo 1300 1500 1700 1900 ZOD 700 2500 Welengh/nm ro Nearnhre socio of hypronson mesred by When aguouslopiic coment mixtures a wid fo lution Pepsin, hypromale shoud fe be dispese inc she sagan solvent at rato of $8 pes of solvent 01 part of Ipromelose. Coldwater is then ade wo produce the ial ‘olure, Examples of suitable wateemiscible organic solvents ‘nce ehanol and gheol sine papuraion procedure should beused when ehanol and dichloromethane constute completely crganic coolene mire, 11. Stability and Storage Conditions Hypromllse powder i sable metal athogh it i ygros scopic afer dying, Solutions are seble pHi 11, Hypromelose undergoes ¢ rmerible solgel vansormeton upon. heating and cool, specie, The gdleion temperature i 50-80°C, depending pan the grade and concentration of materi, For temperatures below the gestion operas ost ofthe solution dees 1s tenperaure is increased Rejond the glotion tengesture, soni nesses as temperate is incense. Aquos foltion ae conpaatiey eupmentig, provid ing good viscosity sabilty during longterm storage Howes, queussolusios are lable ro mii sposge and should be reserved with naninicrobia preservative: when hyromeose sed 28 visisincresing agent in ophthalmic solutions, enaahenies chloe is commonly usd at the preset Agutous solutions may ako be stilaed by eutoaings the coagulated polymer must be redspesed on cooingy shaking. Hypromelse powder should be sored in a welbdosed contains in co, dy plas. 12. Ineompatibilites Hypronelos isincompethewihsome oxdaing pews, Snce tis ‘won, bypromelose wil nt complex wth metalic sso ionic ‘gansta for inoable pcan, 13 Method of Manufacture Apu form of clue, obssind fom cotton lies ot wood lp, i seaced with sodium bjdoxie slusin to produce 2 swollen alli odidse that i chemcly more reaie then untreated celulose, The alkali calldse is then treted with chlorometane and propylne oxide to produce mety! byéeo- sxpeony] ahs of else The bout ration pnduc is then furlied and ground to 2 fae, uniform powder or granu. ‘Hypronelosecan then he expose anhydeoushydogen chloride 10 inde deolyeriation, thus produc low wsconty ged. 14 Safety Hypromelose i wiley used as an excpet in orl epthalnic, ssa, and topealpharnazetce! formulations. Ii abo used ete in cosets and food produc. Hypromelose i gneraly rgeded 2s a sontoxic and ron ‘nating axel ahough excessive oral consumption may havea [bxtive fie." The WHO has ot speed an acetal daily jnnke for bypromelose cine the lls cnsaned wer not considered wrest haar heh," bf high dosages © bypromelose are being inveigated for teting varous ead drones © Dy tous, IP): 5 pkg Wao 5a De Selig 15 Handling Precautions ‘Oserveacenalpreations aporopit tothe czeunstanoes and qntiy of wazrl handle, Hypromelose dst maybe ieriaing 1» te ees, 50 eye prsesion s recommended, Exossie dst ‘grention shouldbe avoided to mini the rks of exlsion, Hypromelos is combustible 16 Regulatory Status (GRAS lined, Accepted for use 8 « food ddne in Europe Induded inthe FDA recive lgrediens Database (opthabic and ssa preparations orl capsules supesions, syrups, end ables ®& Kaolin 1 Nonpropristary Names BD, Heavy Kaolin JP Kaolin Phar: Kaolin, Heavy US: Kaolin ‘at that the PREur 63 contains a monograph an heavy kali The BP 209, in addon to te monogranh fo beavy kai, aso

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