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Food and Drug Administration OPSSU.S

Analytical Method & Instrumentation Method:ICP-MS per ICH Q3D(R2) / USP / ChP 0412 Instrument:Agilent 7900 ICP-MS (SN: JP97593) with He collision mode Sample Prep:Closed-vessel microwave digestion (CEM MARS 6): 35.6 mg + 5mL HNO(suprapure) + 1mL HO (30%) Digestion:Ramp 20min 200C, hold 15min, cool to RT, dilute to 50.0 mL (Milli-Q, 18.2 Mcm) Calibration:Multi-element std (NIST SRM 3100 series), 5-point external cal