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Novinscak et al

The API must be accompanied by a valid Certificate of Analysis which verifies the APIs quality and compliance with regulatory standards and conducts routine and rigorous third-party quality testing to check for potency, sterility, quality and contamination to ensure patient safety in compliance with state and United States Pharmacopeia standards

The insoluble portion was subsequently removed by centrifugation and the supernatant was incubated with Ni-NTA resin (GE Healthcare) for 2 h batch binding at 4 C

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