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Ion Source Contamination Control Risk Factor: Phosphoenriched samples carry residual matrix interferents Source cone fouling Signal intensity decay Mitigation Schedule: Daily: Capillary wipe with methanol/water Weekly: Full source disassembly in 1:1:1 HO/MeOH/FA ultrasonication bath 4

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Lawmakers brought the modalities into the CLAA framework by adding the words cell or stem cell derived products, gene therapeutic products, and xenografts to multiple sections of the Drugs Rules, 1945, that previously referred to a narrower set of modalities including medicines based on recombinant DNA