Analytical Methods and Control Strategies

Of late there is a marked interest in enhancing the approaches for analytical method development, validation, and lifecycle management. Most of these are aligned to Quality by Design (QbD) approach for drug development. The enhanced approaches mostly utilize risk assessments and in-depth systematic evaluations of critical method variables to identify the controls required to ensure that the measurement uncertainty of a reportable result is controlled to a level that ensures that the method is “fit for purpose”. Traditional subjective methods use partitions, for example, precipitation, extraction, and distillation. ID might be founded on contrasts in color, odor, melting point, boiling point, radioactivity or reactivity. Established quantitative analysis uses mass or volume changes to measure sum.

  • Physical Analytical Methods
  • Titrimetric Methods
  • Specific methods
  • Reagents
  • Miscellaneous Methods

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