The impact of impurity analysis on future regulations

Pharmaceutical Technology

Volumn 31, Issue 2, 2007, Pages

  Rios, Maribel ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

DRUG PRODUCTS PLANTS; LAWS AND LEGISLATION;

FUTURE REGULATIONS; IMPURITY ANALYSIS;

IMPURITIES;

ANALYTIC METHOD; DRUG EFFICACY; DRUG IMPURITY; DRUG SAFETY; ELECTROSPRAY MASS SPECTROMETRY; GAS CHROMATOGRAPHY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; REVIEW; SENSITIVITY AND SPECIFICITY; TECHNOLOGY;

EID: 34748897380     PISSN: 15432521     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (6)

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