Master of Pharmacy: Pharmaceutical Analysis and Quality Control Flashcards
7 cards from real MPharm Master of Pharmacy practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
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Which quality control chart is used to monitor within-batch variability and detects changes in process dispersion?
Answer: R-chart (Range chart)
The R-chart monitors the range within subgroups over time, detecting changes in process variability or dispersion.
In chiral HPLC analysis, what is the function of a chiral stationary phase (CSP)?
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.
What is the primary function of the harmonized tripartite ICH Q6A guideline in pharmaceutical quality?
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.
In pharmaceutical microbiology, what does the Bioburden test quantify?
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.
Which principle governs the separation of ions in capillary electrophoresis (CE)?
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.
What is the 'expiration date' of a pharmaceutical product based on?
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.
In pharmaceutical analysis, what does 'system suitability testing' ensure before a chromatographic run?
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.