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jrulinunussowievase7 Gabapentin 600 mg Tablets fon cavapertin 600 mn tablet quantity 1. itusnsiveevRéh Fim-coated tablet) winfuse 2. vnaavaen Gabapentin 600 me 1 in 3. urvqluuasDnaim tostueraty 4.amnseyionn dualenaumndivquacenuuss Sundin Suduony savindn uneiemetouhsuenly aiisincunvssyian svuuiaewes odratlodioneytion dawisenowtaendady armas Juduony uawinetlaanlddoy quusutmamnndin 1. Identification seertrumadiseylu Finished product specification 2. Fannuondiy 90.0 ~ 1100 % ofthe labeled amount of Gabapentin 3. Uniformity of dosage units srentrumastseylu Finished product specification 4. Dissolution Test Test 1 Not less than 808% (Q) in 45 min Test 2 Not less than 808% (Q) in 30 min 5. impurities Gabapentin related compound A Not more than 0.4% Any individual unspecified impurity Not more than 0.195" Total impurties Not more than 1.09% Goutdun 1. wonensnalétveyq ntunedoud dun iosnnelulsemelne 11 hanludhayritimadewhiuen (vy wo.2 wie ne.3 wo ww.4 wie 0.2 uaoueinad) 12. drundreduneiiowituen (net wie 0.1) wenn wasiBumabonseauRuaumnvosndadt omufiiuneideu (finished product specification) waedarmunqmunneesingay (drug substance specication) TausrrwiilsénsBudhlUmuvsemansensaeerersnqe Gerreyiey vr. 2556 Aa ‘isamrunasessie aos ha . fot ir a footed nsidoysewhanlfouulesuilaiania eehowuudnArveuttoteuidas ‘nunniluneiiewhn gue (0.5) ane 2. tonensfusonninsgnumanne 2.1 nsdidewaetuienelnn desiduumidoivrosnasgunauinnmandninantisnsnilun ein 1 (Good Manufacturing Practices) Tumnnenviamuate mannesgiu GMP-PIC/S sindine yy purrssunnennsuaeen niemnaemoTanay Wlomuanmagiy GMP-PIC/S #1n PI/S participating authorities aludhgamascuniasiaaey Tnuiuanstusestshnemmlsemanrbsdnnrotind 22 maiivuduenhthornsnadseinn FosiehunmMofvsoaneag um aednuwrandnunaror ial maniinen (Good Manufacturing Practices) sranit#agr GNP-PIC/S 91" PI/S participating authorities adushanmazeumannrsaautnuitaamsdusasfelualsemmlsenaamenbifnmeiind 3. seneraqadtnwmueveseriuauos ie 3.1. duunmbsosuseansivesresindinsianivrdidegu (Certification of analysis of Finished Product) Tujunnsndiadidetuitaorina 3.2. dhunmbdavurpansiveneatingiuiae drag (Certification of analysis of Orug Substance) Aélunawanerrjuildathudrosrwiiaveagudneunedadimingay 33. onaravionding mududurnnsduiiudsewi jun vaedimasndindlnnie wanvtogy (finished product) 40 3.1 thy qunnandavostnnfvvestaerd iy (drug substance) fo 3.2 4. hatha 4. Giaerieviosdatrathanediaion 1 meu ani ‘dutrumuanssiosesdunltinautau mat frmunlustotonnumaTi lel . 5. mavsefupaurme adeno 5. wifoduvoufuunnaldoundoeiindminery viediodanndouanmiainlsenlagioutinun Tnulaitidouta 5.2 whdedusaunsdimiunemshinduhodhenvideouindwneineiqann wines sevimidofeverade Inuifewoetiosdte vfaineradnnufimbesranadencistinerevunety Gudmourbishelunaesavieneviqaunn 53 unmnnnriidsia aefoannituivromamstinseveniuldsovvodtalin 4 0 1 senna ft a <= 5.4 Auduoyvow fdsoudeuvdelsiioun 12 dew tuviniudeveu 6.sanavaduy 6.1 WaNTanw’ long term stability gi ASEAN guideline on stability study of drug product maont7a onquowenitiumeneontfudiinuanenssums o1nsuaen neMsansaage Tuvan ernunsarmfiqunns 3022°C ernatuduiin’ 75+596RH 62 nxdiulertuuuutomansuamsfinentima (Bioequivalence) weuioultuentuavueramtity Vifudinnunmensmunnaoamuacen oremoeeneranuy Tauonanatodtnanheuivres ‘ndramunnaenssunnserin suse 63 shanmifotusomvierwvinviagiendviogeondaurreneoarduda i mafinemaninrunnd toad dinilunaihtvvesnmueindomand snrvimedoeiney (thd) 64 dharwenenausnstoyenstatumsvss{ty Green Book wosnaunemaniaraunnd (ft) Burormuneidon ee (orqras glam) §eununriamtabewvney wb Ler me 3 vd erm cy

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