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Analytical Methodology for Impurities in Drug Product

ANALYTICAL METHODOLOGY FOR IMPURITIES IN DRUG PRODUCT [Pg.33]

THRESHOLDS FOR REPORTING OF DEGRADATION PRODUCTS IN NEW DRUG PRODUCTS [Pg.35]

FIGURE 2 Description of different thresholds. The amount of drug substance administered per day. 2Total daily intake. 3Threshold is based on percent of the drug substance. [Pg.35]

VIII. ANALYTICAL METHODOLOGY FOR IMPURITIES IN DRUG PRODUCT... [Pg.27]

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