DEMONSTRATING CAPABILITY TO COMPLY WITH …

DEMONSTRATING CAPABILITY TO COMPLY WITH A TEST PROCEDURE: THE content uniformity AND dissolution acceptance limits ( cudal ) approach Jim Bergum September 12, 20111 Key Responses For Batch Release Potency (Average Drug Substance/Dosage Unit) dissolution (% Drug Substance Released at Specified Time) content UniformityUSP <905> The degree of uniformity in the amount of the drug substance among dosage units. 2 Harmonized uniformity of Dosage Unit (UDU) TestAll measurements of dosage units and criteria values are in percentage label claim (%LC). At each stage calculate the sample average and the sample standard deviation testedPass stage if:S110|M -| + , where M is defined ) |M -| + using all 30 results (S1+ S2)ii) No dosage unit is outside the maximum allowed range of *M to *M.

demonstrating capability to comply with a test procedure: the content uniformity and dissolution acceptance limits (cudal) approach jim bergum

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  Approach, Content, Limits, Acceptance, Dissolution, Uniformity, Demonstrating, Content uniformity and dissolution acceptance limits, Cudal

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