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232 ELEMENTAL IMPURITIES—LIMITS

232 ELEMENTAL IMPURITIES—LIMITS

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WM = weight of component in a dosage unit (g/dosage unit) DD = number of units in the maximum daily dose (unit/day) The result of the summation of each impurity is NMT the Daily Dose PDE, unless otherwise stated in the individual mono-graph. Before products can be evaluated using this option, the manufacturer must ensure that additional ...

  Unit, Dosage

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