1. Substances are regarded as unsuitable for inclusion in an official article and therefore prohibited unless:
(1) they do not exceed the minimum quantity required for providing their intended effect; (2) their presence does not impair the bioavailability, therapeutic efficacy, or safety of the official article; and
(3) they do not interfere with the assays and tests prescribed for determining compliance with the compendial standards.
2. The air in a container of an official article may, where appropriate, be evacuated or be replaced by carbon dioxide, helium, argon, or nitrogen, or by a mixture of these gases. The use of such gas need not be de-clared in the labeling.
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