MPharm Master of Pharmacy Master of Pharmacy: Pharmaceutical Analysis and Quality Control 3

Question 1

In HPLC analysis, what is the significance of the 'tailing factor' (T)?

Accepted Answer

Quantifies peak asymmetry; T>2 indicates significant tailing

Answer

The tailing factor (T = W0.05/2f) quantifies peak shape; values >2.0 suggest excessive tailing that affects accuracy and resolution.

Question 2

Which atomic spectroscopy technique is most sensitive for trace metal analysis in pharmaceuticals?

Accepted Answer

Inductively coupled plasma mass spectrometry (ICP-MS)

Answer

ICP-MS offers sub-ppb detection limits for elemental impurities, making it the most sensitive technique for trace metal analysis.

Question 3

What is the purpose of 'out-of-specification (OOS) investigation' in pharmaceutical QC?

Accepted Answer

To identify root cause and determine if result reflects true product quality

Answer

OOS investigations determine whether a failing result is due to laboratory error or a genuine product quality failure requiring batch disposition decisions.

Question 4

In near-infrared (NIR) spectroscopy for pharmaceutical analysis, what type of bonds primarily absorb NIR radiation?

Accepted Answer

O-H, N-H, and C-H overtones and combinations

Answer

NIR spectroscopy detects overtone and combination bands of O-H, N-H, and C-H stretching vibrations in the 800–2500 nm range.

Question 5

What is the critical distinction between 'accuracy' and 'precision' in analytical method validation?

Accepted Answer

Accuracy is closeness to true value; precision is reproducibility of measurements

Answer

Accuracy measures how close measured values are to the true value, while precision measures reproducibility of measurements under defined conditions.

MPharm Master of Pharmacy Practice Test

MPharm Master of Pharmacy Practice Test

MPharm Master of Pharmacy Master of Pharmacy: Pharmaceutical Analysis and Quality Control 3