Application note: ICP-optical emission spectroscopy
The U.S. Pharmocopeia is in the process of revising the analytical protocols for the analysis of metals in pharmaceutical products. A detailed summary of the methodology and the changes is available, so only a brief description will be given here…
The U.S. Pharmocopeia is in the process of revising the analytical protocols for the analysis of metals in pharmaceutical products. A detailed summary of the methodology and the changes is available, so only a brief description will be given here.
The new methods that will be enacted are USP Chapters <232> and <233>, which deal with inorganic content in pharmaceutical products that enters the body through consumption, inhalation, or injection directly into the blood stream. With the exception of large volume parenterals, the upper concentration limits of inorganic elements which can enter the body are based on a maximum permissible daily exposure (PDE) – these are defined in Chapter <232> and shown in Table 1 for orally consumed medications.
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