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  • Gen Chap 2232 USP 41 Elemental Contaminants in Dietary Supplements

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    Elemental Contaminants in Dietary Supplements

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    Elemental Contaminants in Dietary Supplements

    Hak Cipta:

    © All Rights Reserved
    Unduh sebagai PDF atau baca online dari Scribd
    Tandai sebagai konten tidak pantas
    10 tayangan6 halaman

    Gen Chap 2232 USP 41 Elemental Contaminants in Dietary Supplements

    Diunggah oleh

    Social Service (V)
    Elemental Contaminants in Dietary Supplements

    Hak Cipta:

    © All Rights Reserved
    Unduh sebagai PDF atau baca online dari Scribd
    Tandai sebagai konten tidak pantas
    dari 6
    18186 (2091) / Dietary Supplements usr at the contents by washing witha suitable slvent, Allow he ocd sen to eporate rm the sh atom ent (esa pete fsbo 0 mnt ing precnonsto avodupake oes of motte Weigh the ddl se an (SEs net content. The egieants fea sated under ord Copies ‘TABLETS ‘bles conform othe citer en the accompanying able, Uncoated Tablets and Film-Coated Tablets igh induny 20 hoe ables, and calc the average weight The eqirerents are met He weight ft noe shan Bol he bls from the ange weight by mare tan the percentages nthe accompanying tbl sr {St dain ght by mere han double hat percentage Coated Tablets (Other Than Fllm-Coated Tablets) Weigh nduay 20 whole ables and calcite the average weight tbe ated bles donot confor to he ci thecomparing te, pace 2 tbls in ester of woe a 37, an et gy for not mere than nutes. sarin {Recor Iorertyce of Snteation and spe the procs ora sore te ietgraton has begun. Dry the > 1350" or 30 mut, Acura wen 20 snd let eres and cate erage weg “th regaremens se met # Re vaghs not re than? of he ables eer ry te rage weigh By res pcrecrage se me secomparyng able and nota tern weight by mare than double tht percentage criteria eight Vrton aera fr Une Tablets, Fm Contd Ties and one ats (Othe Than Him Coste aes) ‘Average Wight of Tablet ‘nrerence (2232) ELEMENTAL CONTAMINANTS IN DIETARY SUPPLEMENTS. Te objet of his general chapter i tan the amounts of met cntminants in fined tary suppene ts pele beled 9 contoning to USP on stand is general ape sot nde To se MKS or cay 90 ‘Ra Tow i ae set te eotesponng hue! mooaraps "hc tacs ths gener chapter the for major semen toxKlogia cance: asi cam, tea a ryt etent of testy can deterane wing a akbsed approach ht aes ina acount the etnood eh Tho tufts shoud cose the presen a unexpected elena contaminant determine compo LIMITS OF ELEMENTAL CONTAMINANTS “Tete fear contaminants sould be estrada shown nT fs ober ted in he ihn graph Spctc nonotaie may pine detent hts fe aces Wate oe consumed in age ues | use Dietary Supplemes | 2232) #187 os tienes i a hen rant ONES ns be ype ous ceaeee eee en ‘nce it mosnare eames acts apawaingemmnnsnceen tera mM ‘anenc may be mesired sing 2 nonspeciation procedure unr he asmpton hat ase cotaned inthe supplement 'sinthe organic lrm, Whee the nts exceeea wing a nanspeation procedure complance wih Webs oe SETS taro i cain eon tty ent eye OPTIONS FOR COMPLIANCE WITH THE LIMITS OF ELEMENTAL CONTAMINANTS. In cre oat supp nie dosage er acm wth the sor mental contiinats x described ts chapter the le! fern centaranantim the bnahed tay supreme sd NT the Poe he fakes ‘hee options are able for deterring complance wi he ln force orton anspsene Dietary Supplement Analysis Option esgrtn nay pai nth ann he ne tape doug om nae acorn te ‘rocedtsin the general apts Earl Ipurter Pease 2390 he pein pcedane en etn ‘he eats otaed om the rays oa yal eng Se, sale taney date, scoured te FO 3 Anata: Proceed 38 ect blo in this copter. ‘allt he mesure arcu ofeach een contaminant aly ta, a¢ esa = MISS «8 {MUS ~ esi amount of cach leant contaminant ageing ee) =x day ake ef the upement recommend the abn (ering) ‘Acceptance citer: The menured around ahe NNT the OE value Senn Tobe Individual Component Option ‘Ths option apecabl thse etary supplement age am wth 2 maxi dlink of NM 109 ofthe et supplement ised pret ‘nats: “Unies other pei in the inl monograph, proceed withthe incl ngredet a decd below intr caper ‘Acceptance citer The product masts the requrement when eich ompontnt wet prep the ished tary sup ‘lent met the brits gen Tbe? Scent ty cpap mtn vanamngamvneoemeenrnreneee me ‘Set ts erent te he they [Nore components in frmulton meet the kts gen fr he adil Cmpoent ini, thee compen can be ‘sen any propoon Noarther clon neces} {8188 (2232) | Distr Sopplements useat Summation pt ‘orn cnet ie nap gente mn pa egies se dara Nee re mean ve macaroni prentotbedlign aan Sa omr chm na es tyne veaeuce 8 {= seal contaminant concent nthe ind component ag) Wife wag ofeach int component pee serang afte itary spleen (ig) Nimo diy nate he gpm recmmend in eben erg.) ‘Acceptance era he clea amour acca contaaar dey ake NMT the PDE valu ie ole i tat [ANALYTICAL PROCEDURES FOR TOTAL ELEMENTAL CONTAMINANTS Pevtermance base methodology fray foal leantl eantamians a gone chapte emer impute cine 253)s appeal fr tay sappemens Te aketinn neces al a depending on the sston In al ve op ‘lors dexeibedin he eedon ton fr Compan nthe Lm Bet! ntaaran the wef Vato Lm Decree men inpurtn Proce (733) may be appropiate Hower, ote Surton Opto, ace Itech ef wknton mt be etemined ona ene cape ess. Vato of» per xing the Vatdaton of Guo Powers (Berit Input oct (238) = acepase lo af opr under al curses ands = {rea The etermotn of he evel alton necesiy at the dcreon ofthe manufacturer ad the compen tery auton Analytical Procedure for Inorganic Arsenic sere he evel of tl asec exceed he init recommended thi chapter, specaton maybe uel to deter ent! orgai atari present The fling procedure sggeted fo arma erga seni, Dut ah “med proce shown to gh equal or beter esl ca be We ‘porate Se ure ‘we 1, Spec appr forthe determina tnorgaic ase (A 280k sation at 8, eve hn Powintey SO cgay, Creu condeseB, pashan or secu fnne). Reagents ‘Betauon seducing slation: 3009 of possum fen 100 mLof wa. (NoTE—Prepae fresh on the ly 8) Conte ys fase) ao mL! sandon Msen Soir) [NoTeUse Wis amount ater tan the 3.0 specie a Str Papoonon nthe geet hap Asene (211), Method uses etry Supplements (2232) 8189 Sample solution: Transfer 200-9 ample tht has prey btn grund opas though 2 60-mesh seen to si lao ak (3. To the as a 35m of hyrachiae ai 6 Nand 13 oh sane stn tare fr 3 i toe rection of arsenite [AVL connect the as tothe recente chabe()y samp te ssemy le appara {nd tpi ceulating ap water Uvough te condenser (C). Hall he lowe oa abe ot the ah ead (0) mai eer, ‘Maneuer tne stopckto cause the content the rece chamber oa the aon fh hel the ak ur he {epee shove tne soon reaches TOD™110" and conte rein th tesa for 15 Chose the topes {oninue heating a 108-10" aed collect 30-33 ro Site nthe ect chart amon the Pein soc. e Blow the temperate to dap about 8" Gos the topeoct, anda second 3:m portion of 6N hycochrid (CD an 1S mio the Osten retin salon dough he themomtetopering wo the dstalaon ak. Replace the themarste, nce te temperre {710 and cotet second 30" to 33M. pon fdas inthe recone chum ante secon! st i the ‘eae contain the fist potion, and oa the camtied Sata to oom tempera Remove te splash Reason wash |Scontnts nto the beaker. Also, wash dow tee ol the condos and rece cramer wth water, colette tshings tothe beaker Taner to a 100-n.vuuetc Nak ad complete wh nto vole ‘nati Determine the arene conten bythe veP MS pred meray mp Prete 233). Aes, 2 mo potasum die Tana 0 mo svonger sid slaneau rane TS tt Song slr contained Ine Etenmeyer is nd proceed as detedin wont (27), Meta Poca, ging wth “Alot sar th peti 30 mites Analytical Procedure for Methylmercury here methyimercury determination equted, te folowing proces sige Howes, ay sobted procedure sown fo ge equal or beter tess ca be ad Procedue hs procedure wes an aqueous exroctn ofthe merci specs with anti stn HPLC veparation ofthe dete stad mercy specs hs mode phate 0 cntaing pti snd ICP IS dtson ‘stein soltion” 1% ceysne hyrocnide manahyaate ate, Moble phase: 0.196 .ostne ydracionde monchydate and 0 stele fee bse in water Standard tock solution lof meray (a) a meyer ci at uo rear (Hg) 8 mercury

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