MPharm Master of Pharmacy Master of Pharmacy: Pharmaceutical Analysis and Quality Control 3 — Questions and Answers
Question 1: In HPLC analysis, what is the significance of the 'tailing factor' (T)?
- Measures column efficiency in theoretical plates
- Quantifies peak asymmetry; T>2 indicates significant tailing (Correct answer)
- Describes selectivity between two adjacent peaks
- Indicates mobile phase flow rate consistency
Correct 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.
Question 2: Which atomic spectroscopy technique is most sensitive for trace metal analysis in pharmaceuticals?
- Flame atomic absorption spectroscopy (FAAS)
- Inductively coupled plasma mass spectrometry (ICP-MS) (Correct answer)
- UV-Vis spectrophotometry
- Neutron activation analysis
Correct 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.
Question 3: What is the purpose of 'out-of-specification (OOS) investigation' in pharmaceutical QC?
- To recalibrate instruments used in testing
- To identify root cause and determine if result reflects true product quality (Correct answer)
- To retroactively adjust test results to specification
- To update regulatory filings with new limits
Correct 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.
Question 4: In near-infrared (NIR) spectroscopy for pharmaceutical analysis, what type of bonds primarily absorb NIR radiation?
- C=O and C=N double bonds
- O-H, N-H, and C-H overtones and combinations (Correct answer)
- Aromatic ring systems
- Ionic bonds in salt forms
Correct 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.
Question 5: What is the critical distinction between 'accuracy' and 'precision' in analytical method validation?
- Accuracy measures reproducibility; precision measures correctness
- Accuracy is closeness to true value; precision is reproducibility of measurements (Correct answer)
- Accuracy applies only to primary standards; precision to secondary standards
- Accuracy is determined once; precision requires three analysts
Correct 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.
Question 6: In pharmaceutical quality control, what does a 'certificate of analysis' (CoA) primarily document?
- Manufacturing process parameters and batch records
- Test results confirming a material meets its specifications (Correct answer)
- Stability data for the shelf-life determination
- Regulatory approval status of the product
Correct 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.
Question 7: Which dissolution apparatus (USP) uses a rotating basket to hold the dosage form during testing?
- Apparatus 2 (paddle)
- Apparatus 1 (basket) (Correct answer)
- Apparatus 3 (reciprocating cylinder)
- Apparatus 4 (flow-through cell)
Correct 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.
MPharm Master of Pharmacy Master of Pharmacy: Pharmaceutical Analysis and Quality Control 3
In HPLC analysis, what is the significance of the 'tailing factor' (T)?