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Impurities degradation-related

Process-related impurities Degradation-related impurities... [Pg.92]

The selectivity of an analytical method is determined by comparing test results from the analysis of samples containing impurities (related compound), degradation products (originated from samples submitted to stress conditions), or placebo ingredients with those obtained from the analysis of samples without impurities, degradation product, or placebo ingredients. [Pg.454]

Typical testing for stability studies includes appearance, potency, chiral assay, and related substances (impurities, degradation products, and contaminants) by HPLC assay, water content by Karl Fischer, identification by NIR or NMR, melting point by DSC, plus microbial testing. [Pg.429]

Olsen BA, Baertschi SW. Strategies for investigation and control of process-related and degradation-related impurities in Pharmaceuticals. In Ahuja S, Alsante KM, eds. Handbook of Isolation and Characterization of Impurities in Pharmaceuticals, Volume 5 of Separation Science and Technology. San Diego, CA Academic Press, 2003. [Pg.45]

Determine feasibility for related compounds Analyze all related compounds available (process impurities, degradation products, etc.) and perform purposeful degradation on the API. Determine interferences. [Pg.150]

Definition The specificity of an analytical method is its ability to measure, both accurately and specifically, the analyte in the presence of components that may be expected to be present in the sample matrix. Specificity may often be expressed as the degree of bias of test results obtained by analysis of samples containing added impurities, degradation products, or related chemical compounds when compared with test results from samples without added substances. The bias may be expressed as the difference in assay results between the two groups of samples. Specificity is a measure of the degree of interference (or absence thereof) in the analysis of complex sample mixtures. [Pg.1021]

Baertschi, S.W. Analytical methodologies for discovering and profiling degradation-related impurities. Trends Anal. Chem. 25, 758-767 (2006)... [Pg.198]

Gorog, S. Bihar, M. Csizer, E. Dravetz, F. Gazdag, M. Herenyi, B. Estimation of impurity profiles of drugs and related materials, part 14 the role of HPLC/diode-array UV spectroscopy in the identification of minor components (impurities, degradation products, metabolities) in various matrices. J. Pharm. Biomed. Anal. 1995, 14, 85-92. [Pg.3475]

Is this a process- or degradation-related impurity, and under what conditions is it produced ... [Pg.23]

STRATEGIES FOR INVESTIGATION AND CONTROL OF PROCESS- AND DEGRADATION-RELATED IMPURITIES... [Pg.89]

The overall strategy for investigation and control of degradation-related impurities can be illustrated as shown in Figure 12. Stress testing studies provide the foundation for the overall strategy. Various parts of the strategy are explored in more detail below. [Pg.104]

As discussed previously in the chapter, there are two major analytical approaches to the search for degradation-related impurities chemistry-guided... [Pg.104]

FIGURE 12 Illustration of the overall strategy for investigating and controlling degradation-related impurities. [Pg.104]

The use of alternate detectors is an important tool to consider when investigating degradation-related impurities. If mass balance can be achieved using a detector that provides a response that is proportional to the mass of the analyte, such as the CLN, further investigations using other analytical techniques can be avoided. [Pg.113]

FIGURE I Impurity/degradant isolation and Identification process flowchart (RRT relative retention time PRI = process-related impurity). [Pg.362]

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