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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter D - Drugs for Human Use |
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Part 436 - TESTS AND METHODS OF ASSAY OF ANTIBIOTIC AND ANTIBIOTIC-CONTAINING DRUGS |
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Subpart A - Definitions; Interpretations; Requirements |
§ 436.2 - Alternative assay methods.
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Alternative assay methods (including automated procedures) employing the same basic chemistry or microbiology as the official methods described in this part and in the individual monographs of this chapter may be used, provided the results obtained are of equivalent accuracy. However, only the results obtained from the official methods designated in the individual monographs are conclusive.