MPharm Master of Pharmacy Master of Pharmacy: Pharmaceutical Analysis and Quality Control 5 — Questions and Answers
Question 1: Which quality control chart is used to monitor within-batch variability and detects changes in process dispersion?
- Shewhart X-bar chart
- Cumulative sum (CUSUM) chart
- R-chart (Range chart) (Correct answer)
- Exponentially weighted moving average chart
Correct answer: R-chart (Range chart)
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)?
- To increase UV detector sensitivity for enantiomers
- To separate enantiomers by forming transient diastereomeric complexes (Correct answer)
- To convert racemic mixtures to single enantiomers
- To improve solubility of chiral drugs in mobile phase
Correct answer: To separate enantiomers by forming transient diastereomeric complexes
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?
- Defines impurity thresholds for new drug substances
- Establishes test procedures and acceptance criteria for new drug substances (Correct answer)
- Provides guidance on manufacturing process validation
- Describes pharmacokinetic testing requirements for new drugs
Correct answer: Establishes test procedures and acceptance criteria for new drug substances
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?
- Endotoxin concentration in injectable products
- Total number of viable microorganisms in a non-sterile product (Correct answer)
- Sterility of parenteral preparations after terminal sterilization
- Antimicrobial preservative effectiveness
Correct answer: Total number of viable microorganisms in a non-sterile product
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)?
- Differential partitioning between stationary and mobile phases
- Differential migration of ions based on charge-to-size ratio in an electric field (Correct answer)
- Ion exchange with charged functional groups on the capillary wall
- Molecular sieving based on hydrodynamic radius in gel matrix
Correct answer: Differential migration of ions based on charge-to-size ratio in an electric field
In CE, ions migrate at different velocities in an electric field based on their electrophoretic mobility, which depends on charge-to-hydrodynamic size ratio.
Question 6: What is the 'expiration date' of a pharmaceutical product based on?
- The manufacturing date plus a fixed standard period of 24 months
- Real-time and accelerated stability data demonstrating product meets specifications (Correct answer)
- The date the batch record was approved by QA
- The shortest stability period among all excipients in the formulation
Correct answer: Real-time and accelerated stability data demonstrating product meets specifications
Expiration dates are established from real-time stability studies (supported by accelerated data) confirming the product meets all specifications throughout the shelf life.
Question 7: In pharmaceutical analysis, what does 'system suitability testing' ensure before a chromatographic run?
- That the HPLC pump delivers accurate flow rates over the run duration
- That the chromatographic system meets defined performance criteria (resolution, tailing, plate count) for the intended analysis (Correct answer)
- That the analytical column has not exceeded its recommended injection count
- That mobile phase pH matches the pKa of the analyte
Correct answer: That the chromatographic system meets defined performance criteria (resolution, tailing, plate count) for the intended analysis
System suitability testing verifies that the complete analytical system (instrument + column + method) performs within acceptance criteria before sample analysis.
MPharm Master of Pharmacy Master of Pharmacy: Pharmaceutical Analysis and Quality Control 5
Which quality control chart is used to monitor within-batch variability and detects changes in process dispersion?