Setting Specifications and Investigating Out-of-Specification Results - Analytical Validation - page 118

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6. ICH Q3B(R): Impurities in new drug products , Fed. Reg. , 68(220), 64628-64629,
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7. ICH Q3C : Impurities: Residual solvents, Fed. Reg. , 68(219), 64352-64353, Thursday,
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8. The United States Pharmacopeia 34/National Formulary 29, The United States
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16. 21 CFR 10.115, Fed. Reg. , 65(182), 56,468-56,480, September 19, 2000.
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August 30, 2000.
18. Brown R., Caphart, M., Faustino, P., Frankewich, R., Gibbs, J., Leutzinger, E., Lunn, G.,
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21. Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or
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22. Current Good Manufacturing Practice for Finished Pharmaceuticals, 21 CFR Part 211,
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