The Impact of Impurity Analysis on Future Regulations - Pharmaceutical Technology

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The Impact of Impurity Analysis on Future Regulations
As technology for impurity analysis improves, scientists are gaining better information and asking for more regulatory guidance.

Pharmaceutical Technology


1. N. Rao and V. Nagaraju, "An Overview of the Recent Trends in Development of HPLC Methods for Determination of Impurities in Drugs," J. Pharm. Biomed. Anal. 33, 335–377 (2003).

2. D. Elder, "To Boldly Go Where No Analyst Has Gone Before? New Technologies in Characterization and Control of Impurites" presented at the USP Annual Scientific Meeting, Denver, CO, Sept. 28, 2006.

3. Q. Wang et al., "A General Overview of Emerging Technologies for Pharmaceutical Impurity Detection and Characterization," presented at the USP Annual Scientific Meeting, Denver, CO, Sept. 28, 2006.

4. Müller et al., "A Rationale for Determining, Testing, and Controlling Specific Impurities in Pharmaceuticals that Possess Potential for Genotoxicity," Reg. Tox. Pharm. 44, 198–211 (2006).

5. R.W. Dugger, J.A. Ragan, and D.H. Brown, "Survey of GMP Bulk Reactions Run in a Research Facility Between 1985 and 2002," Org. Proc. Res. Dev. 9, 253–238 (2005).

6. J.S. Carey et. al, "Analysis of the Reactions Used for the Preparation of Drug Candidate Molecules," Org. Biomol. Chem. 4, 2337–2347 (2006). PT


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