st018 USP.NF Pate by Duyen Dang Dock GUP-SCaAGOSES1EE-4C*3DADOAGDEDSUAA, Oil- and Water- Soluble Vitamins Oral Solution oesmaTion itera Water Sole Vtarins Oral Solute cortisone ormre fhe felloning ob sible vitamins: tan A tami 0 as ocala (tami) (Choker vlan 0), and Viamin € one of mare of the fling water-okbe wang Ascari At rs alent ag Calum Ascrbte or Sadi -acarate, janecbalanin Niacin 2 Nacnaride,Dempesthnal Parhel,pntteni acd (ae Calum Pantene Race Calum Pariah), Pytodne Wyrcterd,Ritfancr Retavie5-Pharshate Sadar, an Thiamine Hyder Tiare Marais cota NLT 99.0% and NMT 2500 of the labled aout of atin AC) a8 etl or esters of etnolin ie fermi aceal (C0, ort plat C0), stann a8 eyecare C0) or chalealarl (0H, 0). ain Eas alpha acapatl (yh) of ape tocopan acetate (Cy Hy,0)e aba tocopbay acid sucenate Hg, aarti C40, ore sts a caleumascerbate (CH 20, 24,0) sadn seca (yHNa0,), and iine (oH; 1N,08) ss iain dechlare or hisine oxo: NLT 90.0% and NM 150 0% ofthe abled amour of eaum pantathnate (C8 (6yHgN0,) arsenal (6,.NOQ. nasa (6,%,NO,) or nlcanide (C,HyN,0) pine ydoclade (C,,ND, HO andiboten (HNO or bee S-hosphate sur HNO?) ad NLT 800% ard NMT 4800% ofthe labels feyanocsbalrin (Cy CON, 0) RE ca ee eth hie ren fo an nl n be lyf the speed rrahote, the method usedteng tates te bling nit Method iat uted] Nor-Ure low aes glassware thoughout ths proces] Diet Tetshyeolran ad acetone 1) Mile phase ethane aston and mhorara (46546570) ‘Standard selaion: 0.29 gi of tal C0) am USP Vien Sn vn Ne—LSP Vin 8 rte Eeniab varin Aa eel retin cea ote pata] ‘Sample soln: Taner an accurately ransure vol of al Solan equate 3.3 mg of eo toa SOD separa fuel ceiaing 1 mf wale an and allo th ners to separate Dacard the aqueous lye andfiler he sent hexane exact though anyerous sou ste into a Dri rund better ask Evaport the scion to cness withthe a of rotary evap rea waterbath antaned al about 6 Inevediatly ad 100m of Divert ewittodneohe theres, nate, ‘Chromatographie system (See chamatearsaty (62 System Sut) Mae \C Deter UY 26611 ‘Cohn S-em reared fom wo cneatnated 4 nm «25m clus) packng ‘Cohan temperature: 0° Flomates1SLmin nection volume: 20. System nab ‘Sample: Stended sluion Suita requiremets Analyse Semple: Stand sltion and Sample ston tate Use hte aati Ol Soon tat sha tinal (C0) te patan af Or Slatin taken fra *lebe,)F*100 fg *peakareaof etl acetate fromthe Standard sauon Gp seoteenaton of ray acetate 0) he Stands slain (i) Gy nominalconsenaton of amin Aas eta (hy0} nthe Sample slzon (uml) ‘Acceptance: 90-250. of he abled ammurt of vtarin As rt (yO) + Croucacernos on ese ( Vrain) Non=here vain (chokeseere or epocakifer is specifedin the folowing proce, se the chemical for present inthe foralation ard herent USP Reterence Sande Ue wat laswaetvauphut his procedure] Diuetarc Mite pace Poa drected in tami A ‘Standard ota § pi of USP Coleen RS or USP Eset Dent hiipvonine apr comispeféccumenGUID-BCAG969.51E8- ACF3-B000-OAG2B35:4AFE,1_en-US?Highlight=waler%20ecluble%20viamin wmst018 USP.NF ‘Sample alton: Tnsferan accu raasure ol of On Selatan egal o 5090 cholcaeera repeater 198 SOO separatory fel ovfaing 10m of water and 20m of dyad alcohol Aa 80 ml of slvr eran, se the stopp and shake for in, Ak aot 150 of ohent xan ingerthe slope: shake anal he hers o repre, isc th aueaus aor Orne sober axa extrac tugh anus dum sleet 2 500k rone-botom fask xaprte the soln to dyes hth a of aretary evapo oer a waterbath mained at abet" renelte a 10.0 mL {oF biven, sult eso teres, nie ‘Chromatographie system: Prepare as dretein Vitamin ‘System uta ‘Sample: Standard souion Sub requrements ‘ela standard deviation NMI 50% ‘Anatye Semple: Standed slton ard Sample ston Messe te peak areas of tain. Calelal the perce Soke taken geal te labeled amount of aes (C0) er egacleera C0) othe arin of Oa sft *(0e,)F*100 iy ~peakares of chlecaealregcaltet er the Suple slin ak ares of colecaeor er egcaitel om th tana station og ~eoncention of USP Chlealierol RS o USP Epesleieo RS inthe Stand olen (nl) minal concentration of chlecaifer or egcacfeoin the Sample salting) F —eorectin factor to account fer the average amount of retanin D presente anata, 108 Acceptance cari: 9 0%-250. fhe labeled cunt vain as chokeslerd (C0) or epoca C40) None lowactie laser thoughout tie proce] ‘ive Acetate id ey ace (13) Petes dren sion: Trnate 90 got potassium hyde plats to 12D. volume sk contain 60 of water. Mt sah, col Mile pare: Methane acetone and mhenare (46548570) ‘Sample saltn: Transfer an aunt of Oa Sau, equalentto1 Sg of aba tocopherol ox 125m. concalak od with a gourds font and acd 750 ‘of dehyéaieg alata Ataeh a ehuxcordener, ndrafxin abollng waterbath or min, Coto a8 3 mf the Potassium hye sluon ugh te andere; ardcontne tortor 20min Reve the fas ram the bth anesrae he condenser wh tou 15m. of water Coal nate wit a nim ‘elu of watertoa 280m sepaatoy fern ine the flask wi 0 mL of -nexare, and adh sings tthe separatory Fue Inset te stoppe, shake \wgecslyfr min areal he ayes separate, ran th aqueous ayer nto second 20-nL separator funnel and rpeat te exvacton wth 0 mf hexane. Discaréthe aqunous lye and combine he hexane exacts, Wash he combed enacts wih 25 mo wae, allw the ayes fo separate, end ecard the aqueous lye Al 3 cops of acl acetic andrepeat the washing procedure twomere tines. Fier he washed hesare lye vough anhydrous sodum sua x0 280m runt ask Rise the furl and sodum slat wih n-hexane, ad adhering the hexane soln inthe ask Evaporte the herare elution dynes wth thea fa eta evapeatcvera waterbath raliabes at about Immediately ad 50 Lf Dive and wid odesohe te residue, Chromatographic system (See chamaiasah 521 system susie) ‘Cohan temperature: 2° Fowrate:30 r/min Injection value: 20 System sua, ‘Sample: Senda slation Suitably eqlramerts Relative standard deviation NMI 50% analysis ‘amples: Star soliton and Samp soon ‘Meese the peak areas. Calclate he percentage ofthe beled aunt of viamin Eas aba tcopheel stn tke: 4) te portonof or sol osu = (ye) *(60,)100 fy =Peakareaof alpha tocopher rom tho Sample sition 2g concent of pa tocophealin the Stand soliton frat) Gy norinalzoncenttin of amin a alpha ocapheol nthe Semple satsten ent) ‘Accoptanee ert: 90%-250.0% fhe labeled arcu wlan E + Atami At, Caio Atenas ano Sent Acoma hiipvonine apr comispeféccumenGUID-BCAG969.51E8- ACF3-B000-OAG2B35:4AFE,1_en-US?Highlight=waler%20ecluble%20viamin antst018 USP.NF (Gen Yimin Aes (5801) INove-Forlbeing purposes, onside Method -Tirimetic Method as Matted 1 ‘Acoptance err: 9 0% -250.0% ofthe abled sour aseate ai (,H40,) elem ascorbate (C,H C80, 7H, 0) arsadum ascorbate (,HNB0,) Net low ace lasaware thoughout tie precede) ‘Standard stock een: 10 lo eyncesalain rm USP Cyan cbalanin (Cystine) 8 n 25% lho Stein a efgeraa ‘Stanerdsolton Otte» sate volume of Sanda’ stock solvion wih wale fa measured oh sch tha after the hcbtion prod as descsbad Anas sed cel wig, Tis ancenaon val fale between 1 and 0O¢ng/n of the Sando zalion Pepae this soliton rehfr each 557 ‘i of the Oral Solin taken, 25 ml ofan amiecu exacting sohton prepared stbeer use to contain each 10 mi 1.29 po asc sedan phosphate 119 of anhyous cir ac and of soum metab Aeclav the mitre at 12" or Yomi, Allway unassohid paricles ofthe exact set anor ot contre necessary ike an alquot ofthe ca scluten with water eta final sluon enaring vain 8, att apprmately euvalnt to that of he ‘Aeld-neotyzed cats 2h Remove teyrochlie ee ‘tome mitre satlaton unr educedpresaue ut ick pasta eains, Recazaie th resbing paste in wate, uth slzion wih 1 Nga yeas toa pf 15107, ard wth watrto 1000mL. 8642090 atin chateol, sr for1h ard te: Repeat he teatment wih actated charcoal Stor undertaluene ina cel place at ereratue NL 10"-Fterthe soliton recite fos cg stage “Asparagine slton:Dissoh 20 gf asparagine n water to make 200 Str nde tlene in aretigo ‘Adeine-quanine-uraell solution: ssl 200 ra each of arn sate, quae hyo, end ral th he ao eet nTOML of 4 Nryéochbc ac ‘ool ad lute wh weterto 200m. Stee undertlune na eres. anti sein: Suspend 0209 anthine n20-A0 mL of wate nest 9 70 ads 60 mL of SN ammenium hxc, anderen he sole soe, Cool nd te wth water 200. tre under tuenein 2 efrgerto, ‘Santstuion A Dissoie 109 of monobasic ptassium pospae end 10 go ase potassium posphateln water to meke 200, sudan Me 10059 vtamifrecacen wih S00 mL of BNIyehocNoi ac nef the mite fot dad 2 op of hyrshine ‘Sattzatuion 8: Diasobe 40301 magnesium sult, 0209 of sodium earde, 0.20 0 fenous ut, and020 gf manganese sulfate ln water mke 200%, tnd ad? crops of hyetoclte eed Stee lan under lune Polysorbate 80 sluon: 100 ino paysrle 8 ialehol. Siena er gear, iain elution A: 10g roan, 1g of iam hydocrd, 100 gf bot, an 20 pot ritcinn 02 Nate aid tase 400 mL Stor under ‘iain etuton 8:20:99 parinchence acd, Omg eakiu pavtthanae, 0 mgt pyridine hectare, AO mg of dora hytachlri, Bmp of ppidoine dinydechtvde, an? get fle acid ar of water ad reirazn cl (23) o make 40 ri Ste, protected rom igh ina eigen, ‘Basal medium stack soliton Prepare the mecum accrsing tthe follwing orale ane decors. A dehyéated ius cntang the sae nrc maybe Asbo igen inthe ordered in ate, cally assohingopse and Tptoptan inte heer cio ag the next ght sohitons inthe resulting sluton he resting cute, aé 10 mo wate, and dseelve Doxose, Sodium actae and Ascorbic ac Fieri necessary the Polsobate {80 scion, aust with 1 N sodium tone toapH of 5 5-60 ade wh Purfleg Water 250 mL sine ore Tryposhan o0se 1 Nhyctocaone ae rom. ‘tain soliton 8 som. saltsoeion A sm Asparaiesetuton sm Aeidiyaoknedcesen sduton 2m Destose ayes 05 Sthen atte, nto 5 Ascot sed 1 Palysrbate 8 soliton smi iiponine apr comiuspecccumenGUID-BCAG969.51E8- ACF3-B000-OAG2BI5:4AFE,1_ en USMHighlight=waler%20ecluble%20viamin antst018 UsP-NF Tomato juice preparation: Centtuge commercial cand omate eso at estof he pulps reroved, Suspend 8 gf arava eral te superrtas, and iter wth he aot reduced pressive, twougha lyerf tele Repeat, necessan, ural, staw-clered ate seared, Store unde tere ina refer Ccttare medum: NoxA dyed none contig te sare graders maybe used provided thet, when constited as drecteain the abating yl & meu equvaet otha oxaned fem the formula ger hee |Dissobe 0.75 got yeast exact 075 go! ded pestne, 09 of antjtous Derse, and0.20 got rrotebas ptasumplatpate in 6-70 of Water Ad 10m of Tana juice prpartioan 1 ml of Poysobate 0 Slvion. Aust ith 1 Nsedum ye tou pe 68 anit wae to 120. Place 16 potone of the aolion nts tubes apg with ction, Slee the ube and contents han uctane 21771 fer Sin, Coos rapidly ae pots sri ole formation sung ram reheating the medion ‘Suspencion med Die ease volime of the Bsa medium sock salon witht equal alume of wate Place 10 porno the ied median inast postion Incuste es or mre ofthe ites by sab rane a puecutr of Latobcllis hich INowBefore frst wingaresh ute s assay, rake NLT 10sucessvevansfers ofthe clue na ned pe Incubate fer 6-2¢hat temperature betwee 30" and 40" hel constant within 205° Ste ina retigeratee Prepare fresh tab care atleast tree tmes each week an donct use tem fr reparng te roculum if ar thn 4 ay ol. The avy ofthe miteomanism ‘cane creased daly otwice-dalyeanefercf the stab cule tthe port were deft try nthe lal hocuum can be obsered2-ah aferineclaton. son gromin care seem ges a sutablereeperse curve andémay ado erat resus tmeculum: N\A roe suspension ef Lactobaclskihmann maybe used as te stock cule, proved iyelés an reculum compare esh culture] Traeteel toma Stock cutue of Lactoballu llchann toto stele tubes each coring Tom cf te Cute med, eubaeteee cre or 16-24 hatatemperese between 30" and 40"hel constant win #05" Under asepticonlns cernfuge he ules and decor the speatart Suspend he cel ttomthe cate n of stele Suspension medum, and eabine Uso stele Suspension medun,adust te volume sothate 10-20 dition a sale 1S educes 70% tranemtance when ead one sutele pects thathas been stata wang of S30 nm equipped wi & Yomi cel andreedagatst {tla TS etat 1008 tanamitance Pepe a4 dion of he asd uapeelen sing tere Bat madam stock slton Nee—Ths en ay be tere, when necessary cba he destedtest response The elsurpnsin 29 clued ie nec. Calan of epecopbetetar: Check the wavelength ofthe specvophterete peal wing standard wavslength cel oer sutale deve Before Anatyte Samples: Standart ston and Sample soliton Deceuse of te igh senahinty ofthe tet panda toni aman of Wimin By tnt and thes of any lensing apt, cleanse retcuusiby uae ans, flowed tferabby heating st 20" fo 2} uso hat-lags 2o-rm #TSDin test tubes abd ter ncessay lessee Tosepaatetectubes ad dpa, 19, 15,70, 3940, ard SOM othe Stand slten To each of thse bes and ou sar empty tubes 2d 50 Tosimdar separate test tubes sa cpt, 10,15 20,30, nd 0 noth Sample sation To each ube 36450 mo the Basaimedum stocksaluton arid sfient water to make 10m Place ore complete sel of Sands ae sample utes ogether in ne taberack a he plate selina second ak er ection of # ck safer random are Core the tubes to reve batal confit ad strike nan aus av at 121"fr Sin arangng to reach ths tparatr fh NMT Orn by preheating ‘the autoclave necessary Colaeapd ae posible atid oor fomatn rau ram our the medium Take precautions titan ory of "teliing and cong condon ugha ears, Breau packing ube loo lesan te aacive or ovescng tay eause vr he heaag Aseptcally 34805 ofthe cunt gach ibe so prepared except two ofthe four orang ro Sten salute (he uninesated ens) ncubate the ‘ubes ata eerste between 2" and 40 elscontant own #05, For 2, Teeminte grow heating temperate NLT 80fr Sn. Coota oem temperature. ft gta he contents, reste tarsmitnce at 80m when steady tates reached hes stad sates observed ew secnds after ataton when the reading eran constant or 30 omar. low apse the se ira terval forte ree on each ube. ithe vansmttance see 100% fr the unocueted blak rade tersistarceaf the culated lank Ite dferenceis eter than Sof heels ‘idence of cortainaten wit frsin mictoargaism daregardhe eet fhe asa, ‘Wi the trnemtance se at 00% forte unnocustes lank rade taranitarce of each ofthe emg tubes Dengue eeu of te aay te sone ‘ateation: Prepare a sanded conceal tesgone cuveby the follwing procedure. Tes fr andresace ay abevartinvdval usnemitances, ot each evel ofthe Standard calclle he respanse ram the sumo the dpale vale of Be taremtance ,) a the detence,y=201~1, Plt ths eeponse onthe orate of croee-2ecten paar ane ne loge hemi fh Stindaed slutonperute ahh abscess fre rae ether an artnet or logaric sale whichever ges the beter approximation oa stalght Ine Draw the stag Ine or mouth cure ht best tthe pleted pot Caluateterespnse,y = 200-1, addng ogee hetwo uaamiances(, foreach velo! he Sample slater Readme standard cuvetheloparthn f the vlune ofthe Standard soliton corespending teach of hose ves ofthat alls within he range ofthe ones andihes pars plots ere Standard Subvactfrom each eget so bined te lozrtin fhe vole, nm of te Sample solute etn te ference X fr each osape ee erage the vale of for eochof thee ormaredesee els toot Z, which que e greet potency, Mf te Sample slvon. Determine he quant, np of eyancabaarin CC, Inte porn of rl Soliten tke: sntlbgM = artlon + ea) Result = nog AM 100 1 =romiral aneant of eynacebalmin inte portonf Or Solin aken Aeplinton: Repeat the ere eetenaton atleast once usng separately prepared Sample solitons. te ference between he wo potencies Ms NM hiipvonine apr comispeféccumenGUID-BCAG969.51E8- ACF3-B000-OAG2B35:4AFE,1_en-US?Highlight=waler%20ecluble%20viamin antst018 USP.NF ‘00a heerean Mish assayed loocteey ofthe est mater foe Dean nd Anais of ote Varn ct), he wo armas fry mare than 0.08 corduetone omer adel determinations Famtha mean oo 0 mere ‘alt of M tht dora try mote han 0.15, compute te rat potency epepsation under a9) Accepts cari: 990%-450.% ote labaled curt janacbalarin yg 2, 2,P) + Cuan Parent, Meno 1 ‘eile phase: 02M manabasie sedum phosphate and metal (973). Adjust wih .7 Mphospiote aldo apo! 32=0. ‘Standard selaion 20 of USP Cale Passos 2 n Mele phase System sual slut: 80 of US? tacens Pasa RS m Maile phase Mx te result Sutin andthe Stand sluton (11). ‘Sample eatin: Equa 8 p/n of elu patente rom Ol Soin Mobil phase Chromatographie eye (See Gomatoghy (67, System Sut) Injection value 20 System aay ‘Sample: Sando solution ard Sytem subi slain ‘Sutil requirements Resolun: NL 1 Sbatweenpatheol and caeon prtenat, Sytem suite solton alin fete: NMT 20 for st the casum pantoheete andthe pantenel peaks, Stand soliton Relaive standard devin NMI 20%, Sond stron analysis ‘Samples: Sando stron ard Sample stron Measure he peak areas fr calm petuterate, Clete the percentage of te able amount ealeum pentthate (©, H,C2,0,,) nthe potion of rl Sob takers Rest jig) *(06,) 100 iy ~peak area of clu partatencte frm he Same sluion og “emncentaten of USP Clean Pansthenst RS the Stand eaten (gL) (¢y_norinalconcentatonof acum prttheate te Sample soliton ram) ‘Acceptance criti: 990%—1500% ofthe abled curt of eakum pctathenate (© C3N,0,,) ‘Standard tock son: Dissohe 50m of USP Calum Partutenste 8S, prevoud dred ad stored nthe dak oer poepherus pentoxide end tected em ‘crpon of mctre whe walging n SOD mL of water @1000-nL vohmatte ask. Adé Tom 02 Nace aelsond TOOL of sad acetate soon (1h 6), arte wh water ovum to bie a corcentatan of 50 ym of USP Caen Pstsanate RS. Soe under lenin aelsgeaa: ‘Standard slain: On te dy oth assay, lutea volume of te Stand stick solution wih wae ten a cocertn of 01~2.4 yg of eam paneer, he exact concentaton being auch hatha respons eared as dete i Anais, 20 and AD mf te Standard elation eine, win ‘i ef water Ad 10m of 0.2 acetic cd and 10 ri of sod acetate slain (in 60), ite with water ou, an ite, Die a measured okie of his ‘Acidenyrotyze asain sour: Mir 100 0fviamir-recazan with Sd of 6N xtocHore claret mir for9=12h,Remeve the yeh ‘tombe mitre by sbaton unr edvcedpresaie uta ick pasta eains, Recszch th resonate in wate, aut he slzin wi 1 Nsodin yoo pH of 15407, ard hte wth watrto 1000mL. 8642090 aetiateachateal, sr for1h ard te Repeat he teatment wih actated charcoal Stor undetaluen i col ploe ata errpemre NL 10 Fre soon fa preiate foma cig tage {ytine-tryptophan sein: spend 09 of cys in asl of 1.090 -typtonan (20 gf a.-ryptoch) n 700-800 mo wate heat 0 70°80 end sda. ydocle a0i(7 19.2) opie, wit string url the sols ae dissed, Coal nde wih waterte 1000 mL Streunder sheng nacoeleace sta ‘Adeine-gunine-waell sen: ssl 200mg each of denne sate, quae hyochlrie end ual wth sh ado esta TOL of ¢Nryéoshec acs ‘Coo ad its wh water to 200 mi Sta under tlre na erga Potyorbate 80 elution: 100i o aysrate 60 nacht ‘Riboflavin-hiaminehyéochlerde-boin seluon: 22 /iof olin, Typo hannehydiochlie anda. yg of ot n ON acetic ae So deren, pected from i na ele. _-Aninabenot acldlaln-pyidaxine ydrochleride gale: 10 of panincbenae al, Sanka lc, ab apy of doe ecard na rir of reuaized alcool nd water (12) Ste ba fg, Sat ssluten A: Disc 25 gof monobasic potassium phosphate and 25 go asc ptesium phosphate water omakSOO mi, AddSérops of hyo cd ‘rep of hychli a, Store under tne Basal medi tock solute Discs the anfytovsDextose and anki Sodium acetate nthe sohtions previous ree acon to Tale? and acs wih Naoeumtystsin toa Hof 68 ite wih waterto 250 iipevionine apr comapefléocimenGUID- BC3AG969.51E8- 1CF3-B000-OAG2BI5:4AFB,_1_ en USMHghight=waler%a0ecuble%20viamin sitst018 USP.NF Acityeyred case sokaion 25m ystne-tptptansokten 25m. Payot 6 soon 025m Donte, ahr 09 Sosumsctate, ayer 5 Adee qusne-uriisten smi IRbcRevn-tnamee hoesonae-bet shen smi -eninoteraeat-naci pds sehr slton sm ‘Stock utr of Lactobaciue plantarum: Dissohe 29 go yeasxtract in 100 mL of water Add maf anhyaous Dexse, oDma af enhycous Sedum eee nd. go gaan heat the menue an a stm bath wah tig un he agar dssohes. A 1-porton ofthe ht slain tothe est ube, seer cover ‘he bes, sterzen an ately at 121" fermi ani alow the tutes 0 coal nan upaght poston Prepare sab cutwes intee er mae ofthe ibe, vig sue cult of Lactobcii lata? neste fo 16-260 temperature delween 30" and 7" eld conta own 205° Stare eligertr Prepare aresh stabofbestock cute every week ar done use fr the Moc he clue aretha 1 week ol Inoculum: Now rren suspension of acta plntanun maybe ued ace tock else povided Il an nocuum campaabe oa ech cue] Analyse ‘Semple: Standard soln ard Some ston Tossniar separate estubes andl, 70 andor.5,20 30,60, and SOmLof he Standard soliton. Teach ube ano fursinlarempty bes ad ‘50m ofthe Basa medion stock soln ard stele water make 10. Tosimar separate esttubes een duplicate volumes of the Sample soliton conespondingto tee ermre ofthe levels specie fore Standort sation, ‘elena eles of 2,20, nd 40m Toeach ibe ad Sm ofthe Gata med stock slo ane sfflet watrto make Tm Plas one core sto! Standard and sale bes togehern on ube ck andthe dplestesetin 2 second ack oseton of ack, peel nando order ‘Coverte bes of bath seres to prevent cooteminaton ard steae in an aoe at 121 for Sin. Coa Ad op of te noc wo ech ube xen: woot ‘he feures cortaning no Standard salon (te uipacalte bens) reubate he besa tenperature between 30" and 37 heb constant 0 within 205° ut fatonng 16-24 feet tere has bee substantal crease nity ithe ibe crtatngthe highest evel of Stands ding @ ped Determine he vansmstance of he ubes nthe allowing mare Mx cosets ofeach be, ard arse an opal cantare f acess ead ie anemitures betwee Si and S60 rm ahen a steady stalls eached Thi stead tte i obrerved afew seconde flr pan when the gubaonetet Wits the vazmitance seta 1.0 forthe wiacatedsiek, read be tanemitance of he ulstedBnk. Wid the Vaemitance se st 100 forthe inoculated (ateulaton: Prpare a sardan concentatortespone cure a flows Foreac lvl ofthe Sarda calubtethe response amt sum of be plese values ofthe ranamtanee ache diferres y=200~ Phi espns onthe ate of cros-tecton paper spat the lari of temo he Standos suton ger tue ene able, stg forte cate ater an athe o slogan seal, whichevet ges the beter saproxnsin te salt ne Dra ‘healer aah cave tht best the pleted pts. Cause esponse,y=200-F, ang together the wo tasmnitances(, foreach vel of he Sale slitan Rea ram he sande cuvethelogathm ofthe volune ofthe Standard soliton corespending to ach of hose values of tht alls within the range ofthe ones andes pars plo or the ‘Standard Suvactfrom ech gat so bined te ogrcen of he volute, Im of be Sanple souten ws tan te dfetence X fr each dosape ee ‘Average the vals of fr ach of he or mare dosage levels to obtain wich equ fe lapelave potency, Mf of he Sample son, Determine he quant ing of USP Cun Paving BS corespondng to caleum partthense(, CANO, nthe portant Orson kn sntlbeM = antlog soe) Caeate the percentage ofthe beled aunt of caiom paratenate 202N,0,,) nthe porion fOr Solin taken: Result Knelog Nx100, N= nornaleneunt ot cleumparteterae inthe porte of Oral seu fr) epllaton: Repeat teenie deernton a east once using epaaely prepare Sample salutes, he ference betwee th two poets Ms NST 16 he nan Wi the assayed potency ofthe eet rater (ee Desig and Anais of oil says (V1, The Confidence hea and Lins of Poteet wo aeerinatos iferby meee than O08, conduct ane orate sada elamiains om Be mean of wo orate vas of M tal dat hiipvonine apr comispeféccumenGUID-BCAG969.51E8- ACF3-B000-OAG2B35:4AFE,1_en-US?Highlight=waler%20ecluble%20viamin antst018 USP.NF Chrematepraphie sytem: Proceed as directed n NacinorNacamie, ‘Standard selon: Equal o 24 yim of USP Pours sacle 8 overt ‘Sample setatin: Equa to 24pm ofPiconneHyereclnie fom Oral Soten Dien Analysis ‘Sample: Sanderd ston ard Sample stron Cala te percentage othe bead araunt af pydxne yerechtide(yh.NO, HCY inthe potan of Oral Solan taken Rest je) (06) 100 peak ara of yioene hytochlaide rem he Sample sauton 6g “emncentaten of USP Pin ydchloid RS nthe Stand san (gin) y_snominalconcentation of rida hyrochlois the Sample ston (maint) Acceptance citar: 99.0%—1508 fhe abled smurf pride ytd NO, HE) Non RlbfavirS- phosphate sours quate against SP btn RS nls prcede. nthe ehrematogtam ofthe Semple salon, terete s-psghate eas the on peak measured for eatuton) ue, Mobile pase, and Chrematepraphie system: Proceed ae deste n Nach orNachami ‘Standard soln: Equal to p/m of USP bola 8S en by hating necessary Sample selon: Equtatt 8 yg nt bata rr Solon nent ‘Analyse Sample: Sanded soliton ard Sample salon INow=The elaive een ines fritters shsphate anata ae abou 0.1 and 1. respecte Cala te percentage othe beled aroun af tesla gNO,) he prt fOr Saline: yr *(0e,)F +10 fy ~pesk cen of mofaveS pho 0 rom the Sample souten fg “peak of roofavn fom he Stans salon = concenatan of USP Ribeten RS nthe Stndid slat ng.) Gy. nominal concent of tot inthe Sample soliton (gi) FF =tectrtorconventing ie maponte tied fr dbf S-phosphat to rafav, 40, New-Rtofovn posphate soda 8 ito someic tmencohcephates wd poeple cortaieg an ewe arent 7H of rate Sanenephoshate nich sapere ins crmloghis tystom The factor 1498 assures 67% of roti S monophosphate] Acceptance eta: 99.0%—1S00% ofthe labeled ecu Rafa HaaNyO,) + ner annten Rae avnS Pramas Sin, MEDCo 2 Noe-Use low-actie glassware toughout tis procedure] ‘Solvent Hank: 1N yor aid 25 M satu setae, and weer (1297) ‘Standard stock soln: ransfer 16mg of US aun # to @ 106m wlumete ask desohe i LOmL of Nhyéochbre aod and20mL of 25M sodum cette ad ae wh weer velune. Transfer TOO mo ths seuton oa TOOL volume ask and aie with waerto volume ‘Standard soldi: Transfer 0 of he Standard stock soliton to SOd-nLvlunate ask, «6460 mL of TN ydochae aesend 0.0 mL of 2SMeadum tetas ad dite wth water took, ‘Sample eotuton: Transfer an azcuratlyransures vor of Oral Salta equa 0 0.8 mg of olan, 9 TOD lune ask, abel ite wth Wate to Volume. Tranefer 1200 ef the eeu soln tox SOL vote Mask, SO mL of 1 Mhydchofe act and 120ml of 2 Msc acetate, and cute (Gee fusresconce Spectescony 8501) Analytical wavelengths lasion: 527m hiipvonine apr comispeféccumenGUID-BCAG969.51E8- ACF3-B000-OAG2B35:4AFE,1_en-US?Highlight=waler%20ecluble%20viamin antst018 USP.NF oat ‘Sampee: Standart ston and Sample sition rar oun ante Sample slutonreapectively Cleat the peerage ofthe beled teva torn, HagN,O,) Ine paren fOr Salton eke eau (lx 66) *100 | fluescercetenty rm the Sample seuion 1, =fucrscerce testy rom the Stand ation + eeeanztn of USP ‘s avo a Standard solten gm.) inal concerto fein inthe Sample slton ran) Aeceptance citi: 90%~150.0% ofthe labeled amount of ofan (eNO) Duet, Mobile pase, and Chrematepraphie system: Proceeds deste n NacinorNacami ‘Standard solo: Equal 24 mL of LSP Ihamnesrnchande 8S Dent ‘Sample elation: Equa 24 pg/mL ofthamiehystetlonde for Oral Soon oer Analyse ‘Sample: Sande soliton ard Sample stron Meas the ate forthe mar peaks. Cause the percentage of he beled ameunt of amine yecorde (C,H, ,AN0S:HC or amine mente (©, )M0,8) nthe poron of Or Slaton ake: eau (yr y,) F100 = peak tea of hiamine from te Sample soliton fg *ptakatea of iamie tom be Sanded sition og. “concenaton of LSP Thiam Hchlsie Bn he Standard soliton (nam) ‘nominal corcentaten of tharine iyéeconde a blanine merautaelo the Sample saluton (vant) F = (fer products conaingbiaminehyetochorde) ané 097 for products containg thane manele) ‘Acceptance eta: 905-250. ofthe labeled curt tains hydochonde (CCN, 08- Hd) arthlamine menelvate (,,)M,0,8) + Aucoin Deron, Mics (61(Fraesext): 9004-12008 of he beled amount C08 + Men Eun Tar (2911 Te ta arbie coil count dons ntexcend2+ 10 cfu andthe conned eld nd yeasts count one nat exceed’ ADDITIONAL REQUIREMENTS. panna we Brower: Presrve init, hts consnes ur an net ge with a nrc hendepce, * Lanne! Thelatel tts thal he routs Oi and Water Sale Vain Oral Soon The kel tes the arty of exch vain pesentina gen vole of parila amin he belag stnes wih ic asay method he pdt complex a Method Tis nol ued + USP Asc Sree 13, 1S Apne Tense Faanine A2.4ahychon-methyt-vabuy clean sak 2) ‘10Secechalet-S710(19)- er 0 2252.78 Hud sano 2 Cressler (rain 040) 2.4DhyeronrA-yernyppy)--dmethyramide 5 10Secoergont 57,119), 72ataana 96.52.7622" iiponine apr comuspefeccumenGUID-BC3AG969.51E8-ACF3-B0G0-OAG2B35440FB,1_en-US?Highi -yater20ecublet20starin vaist018 usP.NF Prdnecabnic eid HN, vant Pdnecaoxarde eo wa iS bude acd ses SA.Pynaeedimetanol Syosset yoshi, iso camie Pantera as bee CiHaaNOy 7036 is Tae etatseas ‘Tazo 3:(4amine-zmetiyeSpimianylmetiyS {nycomety)-tmetiyh, chi menchyerochlnde wsovuanin aes 8 7-.Dmetyh52.6.6eHmetiy-ecohewn 1) 2.46 nenteveer-tolacette (tin Acetate) ar tfratin- Pets check fr vai ue ion inthe FAQs belt contacting USP ‘Tope/duestion comact Expert commiting CL AND WATER-SOLUBLE VITAMINS ORAL Natta Dandove Ns0S2015Non-btanlal Dietary Supplements 2015, +180 168828 hiipvonine apr comispeféccumenGUID-BCAG969.51E8- ACF3-B000-OAG2B35:4AFE,1_en-US?Highlight=waler%20ecluble%20viamin wit