MPharm Master of Pharmacy Master of Pharmacy: Pharmaceutical Analysis and Quality Control 2

Question 1

Which ICH guideline specifically addresses validation of analytical procedures for pharmaceutical use?

Accepted Answer

ICH Q2(R1)

Answer

ICH Q2(R1) defines validation characteristics such as specificity, linearity, accuracy, and precision for analytical methods.

Question 2

In Karl Fischer titration, what is the primary analyte being quantified?

Accepted Answer

Water content

Answer

Karl Fischer titration is a specific method for determining water content (moisture) in pharmaceutical samples.

Question 3

What does the term 'robustness' mean in the context of analytical method validation?

Accepted Answer

Measure of method capacity to remain unaffected by small deliberate variations

Answer

Robustness measures how an analytical method performs when subjected to small, intentional changes in method parameters.

Question 4

Which technique is most appropriate for quantifying residual solvents in pharmaceutical products per ICH Q3C?

Accepted Answer

Headspace GC

Answer

Headspace gas chromatography is the recommended technique for detecting and quantifying volatile residual solvents in pharmaceuticals.

Question 5

In dissolution testing, what does the parameter 'f2 similarity factor' evaluate?

Accepted Answer

Similarity of dissolution profiles between two products

Answer

The f2 similarity factor (≥50 indicates similarity) compares dissolution profiles of a test and reference product.

MPharm Master of Pharmacy Practice Test