See gan oat raced as directed in Evylene Orde cd Sago mL, cee ear: = tol Poyonyiglycerides exnibits the composition profile sslve 0.446 9 of so- Glacial acetic acid to 3.096 ve (401 1 C3 eae ae | re fons, Hyco! Yaw (401) ° in pter, Ifthe vol ros Seat ete VS regret the Mk ssh’ 3 m2 more lke art 5) i: Proceed as cect inthe cha ffcial Monographs / Bentonite 5211 «+ Fats Ano FixeD O16, Sqponification Value (40) ADDITIONAL REQUIREMENTS SPACKAGING AND STORAGE: Pres ‘eonininess, protected (rom heat and mors + Uapttine: "Label itt ref tight, ight-rsistant gsture, Store at ndicate the average nominal molec da part of the ‘or weight of polyethylene glycols offical tle + USP REFERENCE STANDARDS (11), USP Behenoy! Povyoxyighcerides R pEFRITION i. ae 1A, X-RAY DisFRACTION (941, Sample At” Add 249 In sall portons to 100 mL ol vate tense agitation’ Allow to stand for 12 b to tue complete hydtion. Place 2 mk of the mixture ‘obtained on a stable glass slide, and allow to at if at room temperature & produce an oriented film, Fle the sige iv'a vacuum desiccator over a face of ethylene glycol Evacuate the desiccator, and tose the stopcock so that the ettylene glyeo! saturates fe desiccator chamber. Allow to stand for 12 Sample B: Prepare 3 random pourder specimen of Analysis Samples: Sample A and Sample a Record the Xray atacuon patter ofthe samples, and Acceptance criteria The largest peak in the pattern of Sample A corresponds to a d value between 15.0 and 17.2 A. The major peak in the region between 1.48 and, 1.34 Atrom the pattern of Sompe Bis between 1-492 i 1.508 A ipurrries ArsiG, Hethod (211) “est preparation: Transfer 8.0.9 toa 280.m. beaker Containing 100 mL of lute hyghochlonc act Ch 25), imi, and over witha watch glass Bol gent wth ccasora sting, for 15 mint wthout alow exces dive foaming. Pas the het supernatant tough a raphe iow fier paper nto 9 200m valumetr fase an ‘wach ith four 25-m portions Gt nok alate hydroehlo- Hi acl 1 in 25), collecting the masings nthe vol metric ask, Coote combined Mitrates to oom eth Parle ana id die ydrocton wa (25) 4olume.Transter25 ml ofthis slution to a generator flask, and dilute with water to 35 ml. uaa mY Standard preparation: Tansee Sm of Sndord Ae 2 Solute (ig) oa generat tsk, and ite eth water ta 35 mn Analysis: Proceed as directed in the chapter, determine ing the absorba etre5212 Bentonite / Official Monographs Acceptance criteria: NMFS p hy red color frm the. Test + ua {Renee Sond vhon and th Sample soon tray be modified necessary, to obtain solutions of work Sttable concentrations, adaptable tothe linea OF grange Othe instrument I may be necessary (0 emma) ite 3.0m Sample solutions Tanster 3.75 g tc 26 ‘comaining TOO mL of ute hyd Hn Sty and cover with a watch mi foal to room tempera arapid flow fiter paper into 2. ier washings inthe 400-4 beaker ale the com ed mle Bilng to approximate Instrumental conditions Moder Atomic absorpe ophotomety Analytical wavelength 26: Camp Lead holov! eather feuteiis are Be round corre lame: Arand acetylene Analysis: “Determine the ab Salton and the Same =e Acceptance criteria: The absorbacce of ple SPECIFIC TESTS STMicRosiAl EnumenaTion Tests (6 FED MicRooRCANISHS 162). hi smmtczany i Analyslss Disperse 4.09 in 200 mL of wate, mix Acceptance criteria ®'5- 10° + Loss on Devine 731 ‘Anaiyaisr Dry at 10: Acceptance citer: 5.0% 80% + GEL Fommation: x 6 9 with 300mg of magnesium ox ide. Add the mixture, several Unieed oor te 200 ml of water cariained in a blencer of te ately 500mm capaci len herughl for smi a igh 4, tansfer 100 ml ofthe mature to 9 100%ri Usted cylinder, and allow t0 remain indsusbed faa h, NMT ZL of supernatant appear on the ct “To 100ml of water contained red cylinder of 100-m capacity asd Soin Bartions,Sropping it upon the surface of the waist ang allow ach portion to setle before accling the ey oP mass at the bottom gradilly sel UI I occas an ‘apparent volume of RLT 24 mt at th zi end ota th + ants oF PowoEn: Sprinkle 2. on 20 mi water con. Lined in «mortar, Al to sine Tapa aes oP Bete ond te oh wae 10D hs Me Bewin though a No, 200 andar eves fee Daroghhy Wht vate No gt eh gh nash 967 oe rubbed ovr the ve neo fe NF Monographs Neg scushiaameteet perio tS = ne 1 Ehstuwe: abel ito indicate that absorption gf * Uiherte moisture should be avoided folowing thet aoe ee cent a aa of the orig Pasmtank a lot conor ae Purified Bentonite — =a Pte Bentonite isa colloidal montmorilorite ta ween proceed (o remove grt and nonsneleg ner IDENTIFICATION WAL -RAY DifRacTiON (941 ‘canple Ae add 29 Install portions to 100 Ril slo ath Allow to stand a 19 hy nsure compl lace 2 mL of the mang : jlss side, and alta iy ooo lemperte (0 predcéa eiig i Evacuate the desecaton aa ‘cthylene aheal tm 10 Sand fr 7 powder Specimen of x action pattem of the sample ad peak in the paren value besveen 150M : the region between aad my the pattem of Samp B's bean ag assay + ALUMINUM CONTENT AND Macnestan Conte NO! Lard soUtons and the Sample obtan nay be diluted quantitatively wih water neces Hain solutions of sutable concentations adil inear oF working range of the instrument Aluminum content Alyminim standard sock solution: Ose LORS of sluminui ta mixture of 10m of here sid and YO of water by gente heath. Tae the solution to « 1000mt tumetrc fase angle with eater to volume This solution conta te {quent of I mqimi of akin Aluminum standard selutions Tansles 2 3 mi alquots of the dma wandad sto Xp separate 100ml vlurnetic Hest contain 20.4 ol soa chide, and hie eX Wa Sable eck Solution; Taner 02003 Afi) “lone 10 4 25-ml platinum crue cot 4.0.0" lithiim metazorate, and myx. Usna.a ae, umace OF a sutabie burner Neat sow ae ignite at 1000: 5 1200" jor 15 mi, Cool peed ble 3 100-mL beaker containing 25 mc Bitte acid (SO mg/m), and eed an eddtoral fhe cute acd ny ane sobmerang ela ‘ect, Place a baytvorocarbop coated adi Sita barns a ogee asa a save our the comers is 2 os (erore the cc et aa through a rapido fker awe ne ag) Beatie ae tana eg 10 volume Sample solution; ie 4 Hem Soa eS 20 peter Moathat fae (Le Gisolv volume Magnes dilute w equivale 8.0m Magne: flask od Sample Preparec sample s TOO: Instrurmér See Atenof 12h to ixture” 0 aie sf nd rates of Pur ses, and em of O and 1.48 and 11.492 a Be coc vom ots acct: ’ Sta Fate foie Rens ror sects eres cenianie ere ‘and dilute with hotorneter ae : a a and Saniple | TR Sa seat conert salve, transfer with the aid of water tov 10000 Magmesuin ina, 250-ml beaker contaising 20e a Bie” Pure Ben uminum standard solu ery ane dilute wh and Sample tent of the Purified Ber Norms Mitac, Vethod y Hethed | (211) Sandard solution: | 3 mL of Sta” Giger is Mole solution: Transfer 13.3. Maining 100 mL of dilute hydrochlet i cover with a watch glass, ar EadonalSuring, Yor 15, He osm, “algw she insoluble Mate oy eon he ot pernatant tnFOUD, Eng as ite a ome volume I, : lent. as possible in the beaker, eS ik ees esta On) gah ioe a heat to ating, weston Men 338 SE Ta RP dard Arsenic Soution o 2 250-m Bea 29 rea Cin 25) thy, wit With four adaitional 25:ml. portions of hot dlste hydro Chole aid {1 5), decanting each hot supernatant {route iter ne the volumetnc ask At the last extraction, ansfer 3s much ofthe insoluble material as potable onto the fiter Cool the combined ftrates to foom temperature, and add dilute hydrochloric acid (1 1823) 0 we noe ae alysis Using 25-mi aliquot of Sample solution an The star sian Tweat tenn 95 directed in the Acceptance criteria: NWT 3.9/6; the absorbance due to any red color from the Sample solution does not ex yi a product by the Sondra soon TNore—The Standard sobtion and the Sample solution Tray be modited, f necessary, {0 obtain solutions of suitable Concentrations, adaptable to the linear oF work ing range of the instrument] Standard solution: On the doy of use, dilute 3.0 mL of Teas nitrate stock sluton TS to 100 mL. Each mL of the Stundord solution contains the equivalent of 31g of lead Sample solution: Transfer 10.0 g of Purlied Bentonite Te Ssbemt Beaker containing 100 ml of cute hyde Pione acid Chin 25), str cover with a watch gas, Sha bol for13 min, Cool ta room temperature, aid Slow the soluble mater to setle. Deeant the super. avant through avrapifiow fiter paper inte a 400-mL pester |Add'35 mt ot not water to the insoluble matter fine 250-mL beaker, st, alle the insoluble matter to {RUNG She Gecant the supernatant through the fer itottne wool beaker Repeat the extraction with two iGignal 2emu portions of water, decanting each si atant portion through the liter nt the 400-mk eae Wan te ter vat 25 me of hot wate, collect ing ts Hate mn the 400-mi. beaker, Concentrate the USained extracts by gentle baling to approximate See eeeesseate appear, acd 2-3 erops of mie sci heat t olin, and cool to room temperature Ba the concentrated extracts Unvough a rapido Ml cf paper ifto.a s0-ml volumetic flask Tanster the tering contents ofthe 400-mL beaker through the fiter paper and int the ask with water. Dilute to instrumental conditions Ice mtome Absorption Spectroscopy (852). Mode: “atomic absorption specttophotometer epuigped with a decterum are background corection Sri single-slat burner Analytical wavelength: 284 nm {iin ‘Leod hollow-eathode Flame: Aracetyiene Analysis: Determine the absorbances of the Standard Noution and the Sample solution ‘Acceptance cfteria: “The absorbance of the Sample so- ‘iim s NM that ofthe Standard solution (15 ug/)s SPECIFIC TESTS ‘SFyncnosiat Eninenarion Tess (61) and TEsTs FoR Spec Mian Microoncawtsms 62) ts total aerobic mio CSumdoes not exceed 110" ulg, and Ie Mest the requtements cf te tt for absence of Echerhia cl +H 791) Sample suspension: $0 maint Aeceptance criteria: 8.0-100 + Loss on Devine 731) Analysis. Dry at 110° to constant weight Acceptance criteria: NMT 8.09% * Miaiis_ After deter 731), weigh ‘analysis: After determining Loss on Drying (731), we eval of Priel Beane equvaten 033.0. 90 the dred oasis: Over a period of few 5, tansy the Unied sample specimen to a suitable Blender jar | Cantaning.an amount of water, maintained ata tem= | Serature of 2525 that w sufcient to produce amc |- r 5214 Bentonite / Oficial Monographs timed ture weighing $00 9, Blend for 3 min accurately time I aoa! 530 in an prec [er Het ote! ing blending enuses' temperature tse Shove 30°T'fronfer the content of tne blender t0 9 BooLL beaker, er to sana Toy mand ack eatery toa cenpeature of $8 3°, Uang a stab . sneer egupped wily a spina having Toratonal vucerveer equipped sith 2s Gytindor 1.87 cm in inmeter and 0.69 er high at {Seed toa shat © Seem in ameter, the aan from the top tthe mer tothe lower ip ofthe halt being 3 $4 ery, tnd the immersion depth Deng Soom (No, espn), operate the wecorteter at 60 pry for 8 min, accurately ed, and ecard he Sal Tec * Samples After determining Loss on Drying (731), weigh 2 quantity of Punfied Bentonite equivalent to 5.00 9, anslyas Dupes the Samp 300 mi of water ih the id of a sutable blend fed witha 1 jr Us ing, adel 3.0-mL_ portions of 0.100 N hydrachlonc acd Ses, ard 728 sti add» Ore porte si 788s Determine the bit potentometicall at 840 Acceptance citeriat, NMI 29 ADDITIONAL REQUIREMENTS SMpacraae AND STORAGE! Preserve in ght containers Bentonite Magma Derinmmion. Rene torrc Waar esiolo Sprinkle the Bentonite, 0 potion, pop 800 9 of ho ed Water allowing each portion fe becant hor stirring for 24-h, Sti until a unitorm magma is obta add huiied Woierto make 1000. and fie The Magma may also be prepared By meshenical means duch at by use fa DesGe as folly Pace S00 $0 Auted Woterin te Blender, and fle the fanning, ed the Bertnte: Ad Pures Wise ake u {5 10009 oF up tothe operating capacity of Ue bender Biena the mitre for 3-10 min ade Pushed Wate fy make 10004, afd sPeciric TESTS + WichossAt Exuwcearion TEST (61) and Tests fon Spec FD MickooRcantsus (62). meets te teaeenaen of the tess Yor absence of schers col ADDITIONAL REQUIREMENTS *aciacine ano StonsetTukage in tight eontaines eds eee ese Benzaldehyde ' co ! ono Benzoic aldehyde, 105.12 ‘a Bevenzaldehyde (CrH40), Bf cae Soution A: Acetone and lal seis ig analysis: , Glacial eet acl and watec(yg yg) Heat tne = ‘aie ot op ae fase od Ff hold the g aca adjusted tc etd RS and 0.08 mg/m. of USP Methviparaben fet waampatted Standard n: 0.1 mg/ml of USP Bensddehge come aay 0,15 mg/ml of Be Standard s¢ hye in oral os ic system sare Aa R Thy <621), System Suita Benzyt Alea vate chromatog} a Gee (nam Detector temperatur Mode: Gc Column: my «33cm Sm packing H Detector neal saline Toy wmnees “Samples: S)stem suitability Solution and Sandan! Detector: vitabil Columas | Suitability requirements Resolution: "NLI 2.0 between benzoic acl and Mee ylparaben, system sutabilty soliton Taling factor.” NMT 20 for benzok acid andim=i a Paraben, System sutablty solution tat Relative standard devation: NIT 20% f0°063 | | Tompeata ye, Standard solutor E Analysis ee Samples: Standard solution and Sample selva Calculate the percentage of benzaldenyde (GEO) ® the portian of Benzaldehyde taken: Result = (ir) x (GUC) #100 = Beak response of benzaldehyde from ie Samp saluton = peak Fesponse of benzaldehyde om Me Standard solution sinb G = cancentration ‘of Us penualdeyie é andar slur (mein) C. = concentration of Bazaldehyde SE Solution (mg/m) Acceptance crite 98 i 102.0% impunmies + LiMIT OF HyDROCYAMIC AciD Sample solution: shave0.5 mt of Beale Sit of water add Osea of Ns fer add 5 nL of TN sod and 9.1 mg rus aurae 9, ad oo ent Acceptance criteria: Upon the adit ofa ‘cess of hydrachionc ack no greenish BUe Oe precipitate is produced athe 13 Mi