2014
`
`US P 3 7 THE UNITED STATES PHARMACHPEIA
`
`N F 32
`THE NATIDNAL FflRMULAHY
`
`Volume 1
`
`B}: authority 0f the United 5mm: Phunmmpemi CDHFEHEFDH
`Frepumd by the Councii 01‘ Expert: and its Expert Cummirrees
`
`flfficiai fmm May 3', 2:114
`
`i i i
`
`i
`
`il
`
`I
`
`Tf'ivi': designation an the c¢w|
`[if this publication, ”USP NT- EIIIMr”
`is far cage of
`iden'rificaticrn only- The publication contains twn fifiparate mm ndfa:
`.I'J‘Ie United
`States Pharmmc-pe-i'a, Thirty-Seventh Envision. and he Mariam anqu-y; Thirty—
`542mm Edltinn-
`
`THEUNITEDSTATESPHARMJ‘ILCDPEIALCONVENTION
`
`125m Twinhmuk Parkway, Rockvifle, MD 20352
`
`Page 1 Of 6
`
`Thu: manual wi: Hap-um
`attre HL'».1:Ir:I rranr ha
`E-ub :-:'. UEL' n
`'I:'Il: law:
`'
`F“
`
`LUPIN EX 1074
`
`I
`I
`—
`
`LUPIN EX 1074
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`Page 1 of 6
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`

`

`SIR-MGHTH IMPLEMENTAHDM EUIDE'LINE
`
`' —Nnt|'urltrl Permian-t and Iti- $upplement5 heccume efficlel 5th months after [3.3an released tn
`The limited Stare: Phnmluc
`it released cun Net-ember 'I at each
`r. becamet numeral cln May 1 at the {gum ng Ear. This
`the nu hl'Hz- The USP—NE. Iethic
`sin-menm lrn
`enteticun timing give: users mere time Lu bring
`eir methc-dt and pmceciures lrtltt tnmplianfi: with new
`anti revised
`flit-NF requirements.
`The tattle incl-aw describes lhe etfieiel dates at the USP-NF and its su elements. The 2th 3 use 3.54% 3 rr and It: supple-
`ments. interim Rel-Wen AnnouncemenLt I’m-ts] and Fem-flier! Etrl'letl'ns te
`t edition; wilt be gHic'm'l unt|[ Me}- 1} 2m 4. at which
`time the USP JF—NF 32 became: efflu'alt.
`
`..Ie|me uls
`
`lfl'l'lclal me:
`
`Hmhflr '|. 2m]
`
`Ma5r1, 2fl1'1
`
`um.
`
`, l
`
`
`
`
`May-'1. HHS [Mt .1: mwmefl t”. *"F'F'r-‘ETEIH- mi and
`LISP .sJ—Ml fl
`Ru.’
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`Met-1. ems [cheept es film-maul ”if Sunni mph-hang, rut-esr
`hI-rgust L 1'114
`Fubtuuuy t. EDH
`Fl'rt-t SellLlfl'E-rHE-‘III tn Ire
`
`LIII?I Elf—HF IE
`-I:'HJ_RcI.-.i.r.i:rl Eut'etmg
`_
`
`' December 1. 1M May 1. 2015 teases-1 as sulselseued by hit-Hand acumen acetates;
`Jun: 1. W14
`
`Hay 1. N15
`
`- -.J
`'
`
`The table beiuw gives- the detail: Elf the ERA: that. will apply to USP 33.”; 31
`
`Mitt L 2015 {talcum n5 Supereudled by supplements. 1M5, and
`
`:14 gum—gym“:
`
`|._m Insulin)!“
`"HES—I: 5:1;an In: III“
`EW.M@ tu lute.
`_
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`e
`
`
`
`r.
`
`_
`
`rt'JLLJDl5_
`:mst
`
`Hes-[flan Hufletl'ntt publithcad an the USP wctnitc become cidflclal m the cletcl specified In the Rep-mt: aufleh'n.
`
`Nfl'l'll‘.‘ E AN El' WARNING
`
`Cnrrceml‘nfl LES. Parent or Trademark RIgh-tt—Tht inclusiun in The United States Fhurr'rlclmpefa er in the Mammal Fatrmu-lartu' at e
`stunnegraph U“ 3"? dI'I-I
`II'I "HP-EEK“: "finch patent Eur tradesmrt rights may exist shell nut be deemed. and Is nut intetttled
`£15.. a grant. Hf. Dr til-It!ilftlr [if N flit-HEW. any fight Dzl' privilege protected tr}.r such patent er trademark. All such rlg he and
`privileges ELIE 1|!!th II'I U11: FiltEl'It Dr trademark owner, and nu EIIZhEI' person rrta].I exercise the same uh'thtsut express
`pemtissiclr'l. authflTltt'. Elf IIE'ETISE semred tram suc‘h patmt er trademark owner.
`
`cmeernin Use DFUSF or M'- TrtJrI—Mt'entlun Is es1led to the feet that. um and NF text is lull-l.- mpyrighted_ Authurs and
`utlters wi
`tlnrg ta use pattlnnt al‘ the text .thnulcl request permlsslm to de se {rum the Semq er the user: Heard at
`TrIJSIIEE'iu
`
`ch
`I
`h!- til 2'31]: The Unlteui States Pharmam ‘
`12$ winbreult Parkway. Recitt-ille. MD Emits?!Ia
`
`| Cmu‘entiun
`
`:1.|.| rfg'hi: reserved
`
`ISSE-«l: 0195-?996
`
`ISBN: tiflt—l-BIfi-tzat-fln
`
`Printed in 1|"? ”Hill-1d SHINE by United IJ-clcll-t Frees, |nr_.r Etaltllnctre, MEI
`
`Page 2 0f 6
`
`This mltuillnu capllcl
`111th! HLH IIrId met:- In.-
`SLIDJIII U5 Eflfllfrlih'l Laws
`
`Page 2 of 6
`
`

`

`1-4
`
`Amman-Arum
`
`tombr'ned index to HEP .33 and Hi- 33
`
`.I'rrrise o'r-ii, 5135-!-
`FI-rllr'riss'rcirrrneI 133E
`Anlsnln. 12-133
`Annotattons
`to NF 33, SEED
`In USP 3.3'.
`:rrl
`ontnrolina phosphate. 1EIIJ
`Ahlhrhctfie. 13311.
`.I'tnrhrllln. “IB'IU
`ore-1411. 11311
`IZIII'I‘rr'IIEfiL IBT2
`Anthrax sun-cine minis-Ed. 1313
`.I'tnlhrune. Iii-3'3
`Is, Hot.
`Amhhrhts—mtcrohlal film-{151}, I?
`nntmagunnt
`:ilrnso dextrose 'IDILIWI'I. 111-15
`tltrato Elfin-$1311! dontroor mlmim. 13in.
`EIU HEE- phlooplurb: duh-no: adonlnrr
`mhlion. 1.513
`horns-in sohIIon. 312$
`sodlurn more solutton. roro
`Amt-Ell raga-Ir. HFE
`Anti-Er (Rm: mayoral, I133
`M‘i-ffiw 31in iII'IICI anti-faclor I'lu £5.13". for
`mlrootlonaroj and 1m: hmleculal owlnhl
`imparlns rams}, I51
`'
`*nliflum I'm-guns.
`| 135
`I'Inlu'humorn filo-brill tongues-1:, 13111
`hntlmilsroflnl
`nts—contenr {3431. 139
`mine-rm lasting {513, so
`Antim-e'rn-Ir
`palind‘riurflu. 13.35
`Fr-Iolusiurn Ionrm IBIE
`radium tartratn. 111211
`trichlorldo, 13??
`rrlthlorlrle T5, 14-45
`Antluslrlne. 1112B
`.h'IrI trunnion-Hue otn. soluLIun. IEEI
`h-EflJIJEJME, and phEI'I-flkphrino
`WWII-with: mi: :uiulimr. NH]
`Arstitivun‘rlsin III, H39
`humus. 113.21
`-fl-'|:J-I:Jrnor|Jhln4.I hydrochloride, FEE-l
`tHLlleu. NEE
`Maura-Ir lnrrlnslr. rilnohnm—I'Ilssobn-m
`town-1 pro-:emros for rotating disk and
`:IEnI'Jflr'rary :fisi; {111531. E.“
`Inuit-Ilium o1 nurlo-I-r monsoon: resonance
`spectroscopy {1 ross, 1254
`Winn uf 'I'l'fllflT arthrity flatnrmuutlnn tn
`mfilrlln pharrnzrcrruilnd pro-slum {11111.
`hpmclonid‘ine
`hydm-LII-londo, IBIS
`s'rpirlhlh'ni: solution. 15245
`AproharhltnL lash:
`Aprotlnln. 152?
`I'nifitila'r. 13.3.9
`Artltumomah Injrcuon. Iodine-[ions Tr. 99m.
`via-$11
`nrqlnlna. 1821'
`tripod-es... 5.3513
`IHBI‘J
`hyrln'luh|I:Ir||:1|.*I
`|1:.ur|ro-:h|or|doln|octim. 11131
`Lumen. 525-1]
`Aripiprnzoh.
`'IEJI
`Aroma“:
`costar oII. 21H
`elixir, 5-356
`Arsnnilir: acid. ”$31
`
`and sulbattam Tor II1|oct1on. 1.195
`1or oral sumo-mum. 1H5
`131.51qu. 13135
`ultr'r'IFIroflirl'rrI 1300
`Ifl‘lfill
`within |:I|:Iw|:|s-r|I
`Holmium-1, 1M1
`Amyl
`arable, 13-33
`alroho-L 133.?
`White. 15111
`Ili'lfl'te i'rlr-alunt. 'IEEII
`oo-rl'unylm. 13??
`Mylar-IE hydrate. 5353'-
`Jar-Ringo minor, I]?!
`howl-Iii
`capsular. 15M
`hydrud'rloridr. inns
`unruly-sis o1 ii-Ioiogilzal Masai-1.1m“; Erna
`#nalytacal data—Ilitorpnlminn nnd Lrtatment
`UEI'! D}, 5-15
`Marginal inltrummi qualfllrntlon {WE-B},
`.'I.I:Iltst'rrrrr.l;|:||oI 1.11M
`Mrii'la-ry mote-rials l'ar' tel, gum, and mulch
`onglneerod pn'udufls. $11141 311 111'?
`Nlflrngrflpi'list 5-1-15
`calm“. pet-wowed, 5343
`Munch 51:41.!
`Ana-mole, 5-555
`m-nnorliote. 1333
`Angunifni-
`entrud. mud-trod oclsuuronu, 535D
`powdered ochkuooa, 53-h;
`
`
`Anhyd roru:
`MEN-Eu 1333
`allmlno. 1333'
`rurium thin-risk, 151-33
`Lilith-11 L|1||:Iri:r.l-E. 13.3.?
`taklurn |:I|1|:Is|:lhatr-I MIL, JDEIB
`:i-1rlr. arid. 23%?
`(iron: mlfato. 15f?
`dimo'n: soulrmr phospI-mre, I33?
`mugnemm porszh-rroto, IJ-i'i'
`magnnfllm who-to. 13??
`rlrotlmnoL III-'1'
`potassium :nrhnnabp. 15??
`sodium moron; 133'?
`swfliun's Camus-lulu, 13-33
`Indium rhnIph-I'II', i'th'I-r'IUIJDII'T 11139
`soullum sllflaw. 133'?
`Isorllun‘r .sufllto. 11er
`
`* .
`
`I1.InlorI-r:||r'«-Hu 1311.?
`hydnxlflofide. 13113
`worm mint-z. rn'oo
`Injection, 33113-
`Mllirrr. Til-33'
`Halo. I133
`'IHHdlE,
`'I 3-.”
`Minn-endumg-E resin
`Evil- tn Wilma-oh. urnw-rfi'fimyflronfll'fl.
`I333
`nLMIflu. "'1th (Wu-HIM. il'l H11 :11an
`furrIL I3n3'3'
`stymnbdiuinsflhenxene, I33?
`rJ-An-Isoirlnhrdn. 1338
`
`Arrrrnrmium {Emir-strum
`lormarto. 1335
`gryqrrlrlairo, 5155:!
`hydroxide. 133E-
`iydrnxide E- H. 13315
`Inolyh-clotn. 1335-. 1355
`Inulff'lslslat-E Inge-Elm 1313-5-
`molyhdat: I"
`, Hflfi
`nILratE. 133:5
`'14-'13
`nitrate. oEriI'. T5.
`nil'ratn 'I'SI silver. “51
`mull-1o. 133E
`oxalate 13. 1H5
`pnmrlato, 1334.”:
`phosphatu, 5553
`phosphor-n. dibasln. 133d
`phosphate, I_'Iih».l.sili:I T3, “I145:
`phosphate. Imnotlnric. 133:5
`pulywflid-E 35. THE
`FWIdinrdrH-riutarhomuter 133d
`WId-lrmdrrlirn-rnrhamntn. :IotunstorJ‘. T5.
`11%
`White. 13-36
`rE'n'IL-t'lsot: T‘S, I'H-E
`wl'uanE, 'I 3315
`wflalo,
`Iii-311:, SEE-I1-
`:nliaso. :uprll: F5. I443
`More. iorrH: T5. Hill
`wflldo T1...
`lat-+15
`myonnto. rare
`Illifltflntltfl'. Ionrls-mmal [I'M H1. 1454
`'fl'iu-cylnuLE T5,
`1 mm
`ronaoato, I331:
`wnndoi: TE, LII-I15
`Almmrolml sodlum, I351"
`fur injection. 1.3153
`and socnhorbisnl so-ditl'n “poms. 4563
`.AI'rs-oflaquuw.
`|3|53
`hmhl‘nririo. ”EH
`swig-cm Inhints... 1311.9
`Mingus-lino, H3111
`111M215.
`IHEI
`Moonlclllin. 1H1
`inflow. 1335
`tnpsulns... 1334
`and :Inuuldru‘tc potassium 1|:Ir oral
`mas-rrulnn. 133E
`and tlnurlnnal-a potassium lotion. 11'1"?
`ol'rLi Eio'auiflirlr. Lid ExlnrdHJ-mieun
`which. 135-1}
`Ior Injectohio suspenskm. 1:-':-'5
`p11nu1'rnrnrrurrl inlushun. 133-1.
`or.“ susponsrorl. HHS
`Inr 13ml sniper-Hunt, 1335
`“tours, 13315
`IIIIIE'IE tor oral uumnslon. 1121'»r
`hmphulumll'lfi
`mflatr-l
`I311]
`1 33-1
`:ulfuto EMELE.
`Armin-swish 11. I355
`cream. 13315
`Iorlrriocrinn. 1m
`Intiorsl, 3.31345-
`oll'rtrnorflr 1311-6-
`AmpiLi-tfin. 13M
`hnlusfi If?!
`tapsti'or. I391
`lur IrriEIsH-MJIE wspenston. 11115
`[or in|rIo tiLHII, 13"!“
`:5an pruhmflfid 1Ior mil sugmei-em, 133-13
`moluns. ”Furl
`1.rI|u|:I|r- From-13:1". 1391
`
`Page 3 of 6
`
`“11.1 Winn-Dunn:
`.Il H'I-l MAI-ind I'M! III-
`fifllJIEI-UE WW “WI
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`Page 3 of 6
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`

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`E_lu'
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`USP 3?
`
`Mr't'nJ-ttleiegt'trtl Iestt'i' {Elli Antimicrnbial Effectiveness Testing 53
`
`‘tIItIItpteLIEII'LIIII-fl—fi-Ie-ete
`“Wm _ AME—
`]
`lute-charts. cllller pamnl'enls i'II1cluctl1g
`etnulchrns. esic p-rtielacts. ttreilr. nasal
`pee-mus... aIId ephtlsalrnIL prutlucts made
`
`1vttt1.l
`Ine-auttlasrn. cIr vehicles.
`
`
`
`.r!
`
`
`
`Telziiclll'l}I used nrcrduct‘s Irlrlrle s-vfltl liqueur-us.
`hears ctr vell'cles. rIceIsLHrI'le rlusal prcIcLIcla
`and I,lll||,uI.'|rlr|:|l'II'|.'. Including tl'iu-se applet-I
`1n mLEULB'I'I'El'Ifll'I'IIrhtt-_
`Dra' IIIJdLHJ'UI- ether ltl'I-tfl rll'fl-illllds... Hunt-e IIrIItI‘I
`I-IHII-II huffimehF-ht ... ____—,
`Nita-[ids rnaclt- “1th an gauges. hasa.
`
`TEiT DHEAHEIHS
`
`Use culture-I at the llsltewlng mlcrucirgarilsmsl: Candide el-
`br'carrs {ATCE He. Ill-231]. fishery-hm fllgfil't-‘JTJE Ne.
`IEIIIEI-Itj, Escherichia celi (ATIEL' Ne. III-'39}. Pitt-Wanna snar-
`ugt'nam tit'l'tt'.‘ He- IMF}, and Eteialnd'flms'r-HI- rJI-Iretrs {ATEC
`Ha- 55131.net vIabl-e microorganisms used In the test must
`net be mere than live passaga remeved treats the uriginal
`MEI: culture. Fer purpnses at the test. Inna passage Is ale:
`Itned as die master at urgent-ms frem an established cut-
`Iure tcl flfil'l medium. Fill trarrslert- in: ceunted- II'I
`the.I case
`
`at enjanr'rsms malntatned by seed-let let-lthiqufl. each cycle
`ul treeelrrg, thawing, ancI revival in lreI-II'I medium Is laten as
`[me ere-afar. a seedusteclt technique smuid be used fer
`lung—term stmage uf cultures. Cultures fee-tilled freon the
`ATE: si-puuld be muscILated accenzllng tcl directicrns. It
`grew-n In breath, the cells are petleted bycentrlfugatien lib
`suspend |i1 iltfitjth the unlume e1 fresh maintenance heath.
`and add an aquai vulume crl Eli-Lit: {v.r'v in water] nestle glyc-
`erat- Celts grevm an agar may he scraped train the mrfane
`Inta the 'tttIIt-ir. gljcered broth. Dispense small Aliquets tilt the
`icespteIisim-i intt: startle vial-s- Share the vials in liquid nitregen
`Dr In a rnechanlcal tree-tater at nn more than —5-II|‘. IrI'tI'hen a
`
`Fresh seed-stuck vial Is rI:t1I.-Iillt.'IElJ It may the remeeed and
`used tcr Incrculate a series 9' wtfl'ltll'rfli CHINE» These mrlla
`Irrg cultures may then be Ill-IthEl periacttcallv {each day In the
`case of bacteria and yeast; tu- steal the Incrculurn culture.
`
`MED“
`
`all media used In the test. must be tested ler grevdh pee-
`metltm- Use the mlcrueegarsism'l. Initiated ehcive urttltfl' Te-rll
`t'lrgenisms.
`
`FEEFAHATIBH DF IH’DEULUM
`
`Preparatory lu- tt-re test. inn-relate the surlrlce at a suitable
`mini-m: at 5nlftl agar medium lrcts'n a recentlv revived stench:
`culture bleach at the speetfied micrnarganlsn'rs. The ruins”
`cenrtttircn'rs tar the lnnnslum culture IIHT described in Table 2
`
`in which the suitable mile are Serum—Casein ulriest er
`Sabeuraud Deetrese .rlsgar Medium tserr Hicrebt'at' Enumera-
`rJ'arI Tests tut-t :- and Tests I'nr Spen'fien' HI'EruendurItsms {at} .
`Te harvest the bacterlal and IE. n'llsltttns ct.I|t:|.m=_rs1 use ster-
`lle saltne T's. washing the surface grewttt celtecurte It In. a
`
`' rte-HHLrte tIr:-r| Arum-:11 Tm-runurcICe-Iectien. III-5:1 Lust-aerate,I flnute
`est-1|. Henusm. '-I'.*.'r"|III IIIt-EEI'II'il (imp-mvmatccerg}
`
`sulta'lhle vessel, flrltl act-ding sutliclent sterile satire.- TS 1e ah-
`h‘lln El n‘tIEI'IJ-IJIEII EDUI'IL LEI rsIthut 'I
`3-: “It'- LtllrJIIy-Irjrn'llng units
`ltIUJ itEt’ rrtL.
`l'fl hate-lest the cells at .rIt. miter, use sterile saline
`T5 cnntalning [LEE-"it's- nT tmlysnehnle: Bl], anti add suffirium
`slit'e'llle saltrre T'.'i lIL'I L'Il'Jlaln a nclurll. ul ire-haul
`I
`5-:
`'III'.II
`I:lI_.t per
`ml.
`
`IJ'IE stuck enltt-Irt enter-isms may be grew-n
`III-Iternn'L'nIEli-I.
`In a slillafllr. ”guild r'nmiluln (Le... Erivbean-Casein Digest
`Brnth ac Sabeuraurd Deatrcise Brett-'13 and the cells harvested
`11v centrr'lugauars, then washed and resuspended hr :.|.I-tlle
`saline T'fi Le ebtain a micreblal eta-ur'll at about I
`II It?" rILI
`
`per mL. [Nest—Thu estimate tut teneuturu carscer'rtr-aliurs
`s'r'Ia-jrI be perI'IJIrmecl by turbidirnetrlt' ml'uurrrl'IIErIts in: Il'H-
`challenge micrenrgas'llsrns. Refrigerate the HHPErHI'cIn il
`it is
`not used within 2 IIeLirs.]
`newnnlne the niirntier rd r_l|..1 rper mL In each st.I.-.3:Ien.s'r1:rnI
`using d'ie ceriditiuns at media n-an mi: rnttial recaverv Incu-
`batten limes listed In haste 2 tn cuntirrn the Initial rlu |Jer
`rnl. estlmate. This va-tue sen-es to calibrate Il'Ie siae rel l11|'J-i.'|.|
`
`lum used in die lE'IL The bacterial and yeast suspensiens rIrr.‘
`ta he used withn'i 2-1 hriury el harIvesL but the iungal prepa-
`ration may he stared under retrigerattun fer urn he I Lie-rs
`
`PflflCEflflflE
`
`the test can he Hart-ducted ether in Its-s.- Iau'igimlt :mtain-
`ers |l sullleIe-nl value-re at induct i=- aI-InilfllJl-E In each um-
`talner and ”H: tare-dues cantatner can he entered WptiCJlli-I
`[I.L'._, needle and syringe tlrreugh an elasttfl'I'IEIlI: subtle:
`stepper}; err in five sten'le, capped bacterluluglr'al r.r.tInIa|r'II-rs
`at suitable sl1e lnte which a sull'ielefl'l vnlurne D‘l PI'IJ-dLIIEt has
`Inert Iransttnecl. lneculslte each IZt'tI'IIIIII'I'IIr 'Mll'l UI'IE Ill ll'IE
`pee-Flared and standardized innrulum. art-fl "his. lltE volume
`at the suspensien trscrculum used I!- lletmen III-5% and 111%
`at the mini”: .31” the FierducL The canceritratien nt test I'rII-
`ere-erganisms that Is added tn the plfldufll {Cfltflflflfl'fl l. 3.
`arl'l 3} are suds that the final cemcentratlur: L'Il “1'3 IE“ F'WF"
`aratic-n alter tnnchau'nn is between 1 = W" itl'ltl T I Hi" rtu
`per mL at us..- pie-duct. Fer Cale-aerl pmthIsls tIIIItasI'I'lI-I
`the final cmcerstratien at the tfll [JFEitlr1r1'I1il1I'IilltI'I'lI1n-tLllll-
`tIcIn Is between 1
`:r ttllI and I
`:I 1t?" Lit—I Fltll' “11.le ll'ItI [em-LII
`uct.
`
`The Initial emicentratren cit viable mlcreerga I'IISI'n'r in tech
`test plenaratien i5. estimated hasect an the anncentratien nl
`mlcreergarrlsrns In each crl1J1e strinrlardiaed lnuculurn J's Eli'-
`lel'tn'mt-d by the plate-ceurnt rtHfl'l'IflEl.
`Incubate the magnified centainers a1 E i 3.35:2 5-‘JIIII-Ilr
`Elf—It {tantainer at the apprepriale iF'ILEIF-‘flli 5min!” I" I'll“
`3. Retard any changes nbserwd In aPrIIEflF-‘JHIEE' I“ l-l'l'I'II'lI ll'"
`terrals. fleternilne by the plalEIEflunt [IITLIEE'I'IW'I‘ ”"—' ”flm'
`bew' Ial clu present In each test |HEJZIPIFfllWI In: ”1"- "l"F-"l" 'I'lll'”
`intervals (see PF‘E'HLIIIJI'E under MIcrubia-I ILI'IUTI'IL'I'Ut-Il’" rt'il'I
`tell anus run. inrjlrscrihiil-tl Min-nestiurrisms Ids-ti}. Incerparrrte
`an inactivates {neutsatiaer} ril 111E speflllfi fitt'lil'II'Is lttlflul In
`the plate nu.“ I" in the apmprlfitfil riulutlurs prepared lttT
`plating- These cendillnm tII'E EIEIHI'I'IIF'IH' l” ”IE “I‘d-"1'“
`5l”"—'-ll" In: 11ml sample based “pun-i the renditiuns nl media
`and micrebial receverv Incubatintl llmes lislPII irI Futile I".
`Uslng Ilse calctdated mncer'ltl-‘dflur'll ILll I-l” |JI|‘-I' I'l'll- i—III'IIIrnt r'tl
`lhe start a! the test. taluslate the theme in trigIII value-1 rat
`the LencentratJ-un el clu per ITIJ.
`lIZIr @3th mlcrcrerganism in
`
`Page 5 of 6
`
`THEI- IIlull-fill II“ it?!”
`la: st'Ir-I 11L"- lndl'nar I:-
`fishnet Emu-III:
`
`Page 5 of 6
`
`

`

`54 fit} Antlrrllcrablal Effectiveneas Testing I Mkmbblaglcai Tests
`
`USP 3.7
`
`_T|-_I_HI.'I‘.. Ed'tllla {multilin- l’wIn-Iauhll'l'l
`
`l
`
` Jelly“. Mall-1|-
` fmhnfl't'l'llal 'Ih'l'
`EDfW-Ealnm mflfilt fll'tfih;
`
`
`MICE I-lcl. flirt-'3']
`EeyLeen {ate-ill algal: flat
`
`PMEJ'WHIEI I'HIl-lflllm
`finyth'lan—Lalaln tl'lgtlst Bra-th-
`
`
`
`._.5:Wevefle_
`arrcc I-lrJ. amen
`
`
`Embeanufialelrl Digest Erect-I.-
`thymine-arms uurwlt
`
`5:
`-e'.|n--Last'in IJ'i-
`--er
`....It'.'.‘:ii.flfl.éifltl_
`
`{ma'la'a'nlltln'rns
`Habauraud Dream Agar;
`MTG: Hrs. Hug-HI
`Labuuraud Demeflrelh
`alwnme rum-
`Saba-uraud Dbl-m .I".Ig|arr
`
`rancc Hu. lfi-l-tHj
`fiaba-uraud Denim-ac [Iretll
`
`
`
`
`
`the applicable test interrals. and Emma: lite change-s In
`terms at lag reductions.
`
`{IIHEHIA Fflll: AHTIHICIM'BIAL
`EFFEEI'WEHESS
`
`“it".lltl‘lil'
`
`The requirements tar antirrllcrthtrlfll Ellesitl'rfllcss are met if
`the criteria specifier] under Table 3 are met [see Sigm'l'lcant
`FM and J'rn'ummcfi under General Hacker]. Ha Increase ll.
`Ltetiur-tl re an mare than I15 lea... unit higher than the am-
`1new value measured.
`
`rau- a. Erltuh in tune Hymn-Huge.
`
`F“ 1i-"J'i'ElE‘It' .[.'."'"""“:“
`Mm hm. lharl LEI lac] reductlc-n Eran-I line
`
`hind {alclaulted ceLrIt al. 3' days. net
`Isa HIIII'I ill-leg redtlctlan‘lrrn'n Ill-In Ira-
`
`Iial I:t:|1.ll1|
`rl1 1'1 1115-1. I'll-1 I'll?! ill-Um
`__.._
`“111'" the Hggfl‘teur-ln El ItIIiI
`.
`
`
`HI: IIEM-m'l Ira-m 1h:- InlrlI-F r-llrulatea
`Tr-a'n argyle-lint:
`
`taunt al
`i". H, ilfijifli 3:.
`
`
`Far cm m-Ltrfln'm'n
`bacteria-
`Met less than 2-D be refill-Elm Fretmha
`
`
`
`nlu'ul ecu-uni a1 1-1 flat-s. :an na Increaae
`
`
`
`tram “1: Int- EC" cnunl at $3 ell-fl. _
` 'r'eaM and Much:
`
`
`Ha lnwumimm tIIIe rlilirll calculated
`
`5552"" m 1-! and HI da 5.
`
`
`a
`Melee—
`
`
`HFIL‘lIlrII.
`
`Hflt let: [In-I tiling IeducLi-an I'm-n1 Il'nlc
`
`lnillal Ice-Int all In dayt. and HI: 11cm
`
`
`
`nun-I Llle ljlflLmtfltn—tlfiefl
`
`
`he Iletaata I'm-m the lrflan rattliateu
`"'qu anti Helm;
`
`
`cclzlrtl at ll indlfli duals.
`
`
`l"-lI:I increase IrarII the Illltlrlltfllcullled
` lH-cl'elm. 'l'easl.
`
`
`
`
`and Mail-r:
` _rr|unt :II. II and lid-a a.
`
`
`
`
`
`
`{55} BIDLUGICAL INDICATCIRS—
`RESISTANCE FERFGRMANCE
`
`TESTS
`
`TDTAI. “Al-LE SPDIEE EWHT
`
`Far paper carrier bialugical ladle-stars, realm": three spect-
`men: at the rele-rant biaiaglcal indicataas tram their miginal
`individual centiners. Disperse d'le paper intb campanentfi-
`ber'l l:I_I.r placing the test specimens In a sterile 25-DanL cup at
`a suitable blender cantalning we I'IlL at ct'llIIe-ctr sterllleed
`Fun'l'iea‘ Preterm-Id blendlrlg fern tlrne Inner-pen tr; t1: ede-
`quate lfl- itl‘H'tnIE -I-'l heme-genuine:- suspensicln. It is net un-
`utufld ltH' hlcndirlg times at I5 minutes br metre ta be re-
`quired far aptimalrecau'ery. Transfer a lfl-III'IL allquet all me
`suspensian la a «sterile. tcrewrcap'ped h5— a-u 133mm m-
`Far Wei ladirararfar Steam EtenI'iIranrt. Paper Carrier.
`l'rE-Itl. tl‘lc lube cae'I-Ining the suspension In a Illrater bath at
`5'5" th tfltl“ far 15 minutes [Pl-eat shack]. starting the timing
`when he temperature'rearJ'I-E 95". l-aa Went I'mfl'ccrtar
`.l‘ar DryrHeat Hertha-titer, Paper Center, and tar Magical ladi-
`caltar rbrEtnrl'ene [Jaim- Breathe-than, Paper lit-amen heat the
`tube centalnlng the wspenslm In a water but: at ED” la 55'
`far 10 minutes... :tanlng the Emma when the mam-tun: all
`the spur-.- suspensiart reathct- HIT. Canal rapidlyI lh an lee-war
`tar bad: at El“ ta =1“. Tmrlsl'ar t'r'l'til l-rrl-L aliqueta ta suitable
`tlsbesc and malte- apprppriate aerial dilutieru. In sterilized Fan'-
`n'fied ltl'a'rec the dilutlnns belng selected as calculated ta
`fiEI-ti preferably an ta HID-ll calaniu... but nut less than ti. er:
`each aEa pakr elf plate: when treated as cIetcribed belpw.
`Where the blur-aged Indicater has a law spare cent-entra-
`tlan. it may be necfisary La- rn-acfihr thr dllutlan sir-Ila: and ti:
`use mare plates at each diluttan. Freparc a scpttmte serial Elli
`plates for earJt aliquot- Place 1.lJ ml. at each selected dilua
`that: In each at tare 15- 1: tail-mm Petri dishes. Il'llithin 2t}
`
`mlnutt-l. add '[tl each [ll-hie It} ml at Snrbean-Casefn Digest
`Agar Meduhrn that has been melted and EflflIJBEI Le 45'“ to
`54]“. Ewtrl ta attain a hemegeneaus suspensian. and allbw It
`ta sulidiiy. Incubate the plalfi In in Invert-ed pnfitJfln at 55‘
`ta ea“ tar magma lndlcarar far Star-1m Stt‘rflit'tll'l'rlrt. Paper
`firmer, and at 30' te- 35” let Hialagical' [reticular-fer Ethylene
`Dxlde Sten'l'izatl'arr. Paper EtrrrJ-rf anti in! mtg-Ital l'r'r-sfilra'tar
`fitr Dr'trchtli Errn'lleallm, Paper Carriernr at the apllrnal re-
`lttttrer}r temperature specified by me manufacturer. Examine
`
`Page 6 of 6
`
`Tail Inna-III nu: ea-plld
`It'ltuelllflllrdrn-lflll-
`“juemcapplpuL-n
`
`Page 6 of 6
`
`