Pretest P4 AOMK 2024

What is the primary goal of the analysis method validation according to USP?

• To simplify the analysis process

• To guarantee accurate, specific, and reproducible responses

• To ensure the method is cost-effective

• To reduce the time taken for analysis

Which parameter is NOT observed during the validation of an analysis method?

• Cost-effectiveness

• Accuracy

• Specificity

• Precision

What does 'LoD' stand for in the context of method validation?

• Limit of Detection

• Level of Deviation

• Limit of Determination

• Length of Data

Which of the following is a type of precision in analysis methods?

• Reproducibility

• Robustness

• Stability

• Specificity

What is the acceptable RSD value for a precise analysis method?

• RSD < 5%

• RSD < 10%

• RSD < 2%

• RSD < 1%

What does 'robustness' refer to in method validation?

• The accuracy of the method

• The cost of the method

• The ability to withstand variations in method parameters

• The speed of the analysis

Which category of analysis method is used for quantifying major components in pharmaceutical products?

• Category IV

• Category I

• Category II

• Category III

What is the purpose of creating a calibration curve in spectrophotometry?

• To determine the cost of the analysis

• To establish a relationship between concentration and absorbance

• To validate the equipment used

• To identify unknown samples

What is the significance of the correlation coefficient (r) in linearity assessment?

• It measures the relationship between concentration and absorbance

• It determines the time required for analysis

• It shows the precision of the method

• It indicates the cost of the method

Which of the following is NOT a parameter for evaluating accuracy?

• Reproducibility

• Standard deviation

• Precision

• Percent recovery