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(r 0.999), matrix-matched Internal Std:Sc, Ge, Rh, Re, Bi 10 ppb each, online addition QC:Method blank, CRM (NIST 1577c), spike recovery (90-110%), duplicate analysis Elemental Impurity Results Method Validation Parameters Test Method & Conditions Standard:USP Sterility Tests / EP 2.6.1 / ChP 2020 (1101) Method: Membrane Filtration (0.45 m cellulose nitrate, Millipore HAWP) Rinse:0.1% Peptone Water (Fluid A per USP), 3 100 mL per membrane Sample:35.2 mg dissolved in 10 mL sterile diluent, filtered through 2 membranes Media:FTM (Fluid Thioglycollate Medium) + SCDM (Soybean-Casein Digest Medium), BD Difco Environment:ISO Class 5 (Grade A) / ISO Class 7 background, P 15 Pa, viable monitoring / ChP 1105-1106) Test Method & Instrumentation Standard:USP Bacterial Endotoxins Test / EP 2.6.14 / ChP 2020 (1143) Method: Kinetic Turbidimetric LAL Assay Instrument:Lonza PyroGene rFC Detection System + BioTek ELx808 microplate reader LAL Reagent:Lonza PYROGENT Plus, = 0.03 EU/mL (Lot: L8849, Exp: 2026-11) RSE:USP Reference Standard Endotoxin ( E

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Consequently, the PR model was selected for this study

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