US FDA’S answer with explanation for this question is as follows.
Paramagnetic and laser oxygen analyzers are very accurate and reliable when calibrated correctly, these types of analyzers can only detect the identification and strength of oxygen. These analyzers are unable to detect contaminants or impurities that may be present, such as hydrocarbons or arsenic compounds.
USP General Notices, Foreign Substances and Impurities section, says “it is manifestly impossible to include in each monograph a test for every impurity, contaminant, or adulterant that might be present.” .
The USP monograph test for oxygen does not include an impurity screen and other analyzers may need to be used.
For example, assays for hydrocarbon impurities are routinely conducted during the oxygen manufacturing process even though the USP does not list hydrocarbons as an impurity. Also, alternative methods may be needed to test high-pressure cylinders for cleaning solution residues.
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Regulatory affairs in pharmaceutical industry
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