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2024-10-06 16-26

X Bridge certificate of acceptance

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ShahinuzzamanAda
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32 views2 pages

2024-10-06 16-26

X Bridge certificate of acceptance

Uploaded by

ShahinuzzamanAda
Copyright
© © All Rights Reserved
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Certificate of Acceptance XBridge™ Cj. 5 um Batch Number 0247 The chromatographic OC test used to eval documented [7 8]. The mobile phase contain a pH 700 \eproionaied silanols. The tet compounds incude two hycocarbons (2-Methy Nephthal Phthalate), 2 phencl (Buy! Paraben, and two strong bases: a secondary (2°) anine (Propranolol), and a tertiary (3°) amin (Amitrityine ‘We regrt the result for seven difeet relative retention values, as well as the USP tain factors for De two bases. The table below its the resus foreach parameter, and graphically shows where each osu (he rectangle) fs wthn the spesticaton range the ne) The 2-Methyl NaphthalenelAcenaphtene tlatveretenion is a measure of te Hydrophobic Selectivity ofthe mater. T ParaberiAcenaphinene reave relenton is 3 measure of the Hydrogen-Bond Accoptor Activity of the maleal. The Dip Phihaae/Acenaphthene relative retention sa measure of the Hydrogen-Bond Donor Activity ofthe material. The Buy ParabenDipropy Phindate relative retenten is a measue of the Hydrogen-Bond AcceptortDonor Selectivity. The PrepraclaliAcenaphthene relative telefon is @ measure of he 2° Amine Silanol Activity. The Amitipyine!Acenaphwene elatvecelenion s a maasue ofthe 3° Amine Slanol Activity. The Poprancle/Amitipyie relative reertion sa measure othe 2°3° Amine Selectivity To measure the Metal Chelating Activity, we use a tst reported by Engelhart and Lober, which employs a mate o pyridy! (6). Only the 2.2isomer can form chelation complexes wth suriaoe metal impurities, suchas ton. Packing materials with high surface metal concentrations may cause excessive taling of tho 2- isomer. The rato of he asymmetis (As) of the peaks fem these two species ameasue oftha meal celating actly fe the batch of bonded parteles contained in ye +, tentonaly chosen to accentuate the interacton of protonated bates ‘and Acenaphinene), an ester (Drop! and 4 — Sa es racrreree o] ‘Dewpoint 0.08 | | ‘Mobile Phase: 55/45 (viv) MeQH/Butfer “=| | Terpotre 976 TO a Column: 4,6x150 mm feat Ratron a ae 2Metyterconaiee re aan ar saranl Davparteabeoptere 1? Wamacoparicy eeeeeeaiee era steno ias pauenemeees es sinicocael em So scarey erometonaree aR sere sey rrceahatie om 7 kam Gaay meat case a — ppc US? Tae aaa {2s dn Say 22 Dnt Dy fat po cacaan i (measured as separate test) WKFexm S068. APape 22 Quit Approved Sonal Chavan Date: ridge COLUMNS romatogran bud ators X Hyd patio patles, the organic component the 1,2bissiloxyathan bonded to attach the dsiod functonaly, then end ficate of Acceptance XBridge™ Cy, 5 um Batch h ich Numb Acceptance "| provid eee ‘contain bath naga (s panic (organosioxen Physical and Chemical Characterization Properties of the Bonded Particles, Properties of the Unbonded Particles The 90%/10% Particle Diameter Ratio is 2 measure of tho width of the volume-weighted partice size distrbutin, determined using an olocte analyzer. This value ‘aflecis column pressure. The pore sircture is assessed usin Wie repar the single point (at PIP, > 0.86) Pore Volume rmulipoint BET Surface Area [{]. We also report the Phase Ratio, whichis calculated from the poe volume and surface ae (2), Retentvty varies inert with this parameter, The Average Pore Diameter affacs the accessibility of the pore structure to the analytes. The value reported is obtained from the desorption leg of the isotherm using the 81H model (3) Multipoint Nz Sorption bonded Particle Parameter Result /0% Particle Diameter Rato| Pre Volume (ona) on Suctace Area (ng) 189 Phase Rabo (‘lon’) 7 ‘Average Pore Diameter (A) 142 rdcapped materia, and af the conceiaton of he relative fo the major actor affecting selectivity The alumi atfect the with chelating plasma atomic emission spetoscop Total Carbon Content (%) Surface Concentration (umol 1. A.W, Adamson and A. P. Gas, Physical Chemisty of Sufaces, Wiey-Inerscience, 2. U, Neve, HPLC Columns, Wiley-VCH: Now Yor, 1997, pa. 88 3 PC. rata, Analy. Chem. 75 (2003), 6781 - 6788. 4, Nawrocki and B. Buszewsi J. Cromatogr. 449 (1988), 1-24 P. Bare LG. Joyner, P.O, Halenda, J. Am. Chem. Soc. 73 (1961), 273-380, 4.K.D. Wyndham, J, €. O'Gara TH, Waller, K.H. lose, N.C. Lawrence, B.A, Alden, GS H. Engelhardt and T, Leber, Ana. Chom, 71 (1989), 1885-1892. LD. Nave, B.A. Aden, TH, Waller, J. Chromatogr. A 849 (1999), 101 116 7.U, 0, Neve, E, Seow, P. raneta, B.A. Alden T H, Walter, J. Chromatogr. A 849 (1990), 87-100 8 UD. Neue, K. an Tran, PG. Iraneta 8. A. Alden, J. Sep. Sci 26 (2003), 174 - 186. Waters sas of Wears Corporation. © 2005 Wet Corps (Fe), and Sodium (Na ity ofthe residual sianols ayes (6). These values separate stops these panicles are surlace and reported Resul Woters Corporation 34 Maple Street, Millord, Massachusetts 01757-3696 USA. 508 478-2000 www.waters.com

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