MPharm Master of Pharmacy Master of Pharmacy: Pharmaceutical Analysis and Quality Control 5

Question 1

Which quality control chart is used to monitor within-batch variability and detects changes in process dispersion?

Accepted Answer

R-chart (Range chart)

Answer

The R-chart monitors the range within subgroups over time, detecting changes in process variability or dispersion.

Question 2

In chiral HPLC analysis, what is the function of a chiral stationary phase (CSP)?

Accepted Answer

To separate enantiomers by forming transient diastereomeric complexes

Answer

CSPs separate enantiomers by forming transient diastereomeric interactions with each enantiomer at different strengths, resulting in different retention times.

Question 3

What is the primary function of the harmonized tripartite ICH Q6A guideline in pharmaceutical quality?

Accepted Answer

Establishes test procedures and acceptance criteria for new drug substances

Answer

ICH Q6A specifies recommended tests, analytical procedures, and acceptance criteria for new drug substances of chemical (non-biological) origin.

Question 4

In pharmaceutical microbiology, what does the Bioburden test quantify?

Accepted Answer

Total number of viable microorganisms in a non-sterile product

Answer

Bioburden testing enumerates total aerobic microbial count (TAMC) and total combined yeast/mold count (TYMC) in non-sterile pharmaceutical products.

Question 5

Which principle governs the separation of ions in capillary electrophoresis (CE)?

Accepted Answer

Differential migration of ions based on charge-to-size ratio in an electric field

Answer

In CE, ions migrate at different velocities in an electric field based on their electrophoretic mobility, which depends on charge-to-hydrodynamic size ratio.

MPharm Master of Pharmacy Practice Test

MPharm Master of Pharmacy Practice Test

MPharm Master of Pharmacy Master of Pharmacy: Pharmaceutical Analysis and Quality Control 5