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.
Read the first 7 Master of Pharmacy: Pharmaceutical Analysis and Quality Control flashcards as text
In HPLC analysis, what is the significance of the 'tailing factor' (T)?
Answer: Quantifies peak asymmetry; T>2 indicates significant tailing
The tailing factor (T = W0.05/2f) quantifies peak shape; values >2.0 suggest excessive tailing that affects accuracy and resolution.
Which atomic spectroscopy technique is most sensitive for trace metal analysis in pharmaceuticals?
Answer: Inductively coupled plasma mass spectrometry (ICP-MS)
ICP-MS offers sub-ppb detection limits for elemental impurities, making it the most sensitive technique for trace metal analysis.
What is the purpose of 'out-of-specification (OOS) investigation' in pharmaceutical QC?
Answer: To identify root cause and determine if result reflects true product quality
OOS investigations determine whether a failing result is due to laboratory error or a genuine product quality failure requiring batch disposition decisions.
In near-infrared (NIR) spectroscopy for pharmaceutical analysis, what type of bonds primarily absorb NIR radiation?
Answer: O-H, N-H, and C-H overtones and combinations
NIR spectroscopy detects overtone and combination bands of O-H, N-H, and C-H stretching vibrations in the 800–2500 nm range.
What is the critical distinction between 'accuracy' and 'precision' in analytical method validation?
Answer: Accuracy is closeness to true value; precision is reproducibility of measurements
Accuracy measures how close measured values are to the true value, while precision measures reproducibility of measurements under defined conditions.
In pharmaceutical quality control, what does a 'certificate of analysis' (CoA) primarily document?
Answer: Test results confirming a material meets its specifications
A CoA lists specific test methods and results confirming that a material or product meets all established specifications before release.
Which dissolution apparatus (USP) uses a rotating basket to hold the dosage form during testing?
Answer: Apparatus 1 (basket)
USP Apparatus 1 uses a wire mesh basket rotating at specified RPM to contain and agitate the dosage form in dissolution medium.