Validation of Analytical Method_Part II

What does the term 'specificity' refer to in analytical methods?

• Ability to quantify the analyte accurately

• Ability to detect impurities only

• Ability to measure multiple analytes simultaneously

• Ability to measure the analyte free from interference

What does the term 'robustness' refer to in the context of analytical procedures?

• Ability to measure multiple analytes

• Ability to provide consistent results

• Capacity to remain unaffected by small variations

• Ability to detect low concentrations

Which of the following is a characteristic of repeatability?

• Precision over different days

• Precision under the same conditions

• Precision between laboratories

• Precision across different methods

What is the range of an analytical procedure?

• Interval of sample sizes

• Interval of temperature variations

• Interval of time for testing

• Interval between upper and lower concentrations

Which signal-to-noise (S/N) ratio is typically associated with the Limit of Quantitation (LOQ)?

• approx 3

• approx 10

• approx 20

• approx 100

During robustness testing of an HPLC method, which change would NOT typically be evaluated?

• Mobile phase pH ±0.1

• Column temperature ±5 °C

• Switching to a completely different drug molecule

• Flow rate ±0.1 mL/min

Which of the following statements is TRUE regarding Limit of Detection (LOD) and Limit of Quantitation (LOQ)?

• LOD is always higher than LOQ

• LOQ ensures accurate and precise measurement, while LOD only indicates presence
  

• LOD and LOQ are unrelated to signal-to-noise ratio

• LOQ can be lower than the blank signa