Lecture 12

Question 1

What is Specificity in analytical method validation?

Answer 1

Specificity is the ability to measure the analyte in the presence of components like impurities or degradants. It is tested by comparing results of the analyte mixed with sample components to the analyte on its own.

Question 2

What is Precision in analytical method validation?

Answer 2

Precision refers to the closeness of agreement between multiple measurements of the same sample. It is considered at three levels: repeatability, intermediate precision, and reproducibility

Question 3

What is Repeatability?

Answer 3

Repeatability is the precision of a procedure over a short period of time under the same operating conditions.

Question 4

What is Intermediate Precision?

Answer 4

Intermediate precision refers to variations within a lab, such as different days, analysts, or equipment.

Question 5

What is Reproducibility?

Answer 5

Reproducibility is the precision between different laboratories

Question 6

What is Accuracy in analytical method validation?

Answer 6

Accuracy is the closeness of agreement between the true value or standard and the value found in the analysis.

Question 7

What is Limit of Detection (LOD)?

Answer 7

LOD is the lowest amount of analyte in a sample that can be detected, but not necessarily quantified.

Question 8

What is Range in analytical method validation?

Answer 8

Range is the interval from the upper to the lower concentration of analyte in the sample, expressed in the same units as the test results.

Question 9

What is Robustness?

Answer 9

Robustness is a measure of an analytical method’s capacity to remain unaffected by small, deliberate variations in method parameters. It examines how operational changes affect results.

Question 10

Name five parameters that need to be validated in an analytical method as defined by ICH, FDA, USP, and ISO.

Answer 10

Specificity
Precision
Accuracy
Linearity
Range