MPharm Master of Pharmacy Master of Pharmacy: Pharmaceutical Analysis and Quality Control 2 — Questions and Answers
Question 1: Which ICH guideline specifically addresses validation of analytical procedures for pharmaceutical use?
- ICH Q8
- ICH Q9
- ICH Q2(R1) (Correct answer)
- ICH Q10
Correct answer: ICH Q2(R1)
ICH Q2(R1) defines validation characteristics such as specificity, linearity, accuracy, and precision for analytical methods.
Question 2: In Karl Fischer titration, what is the primary analyte being quantified?
- Residual solvents
- Water content (Correct answer)
- Peroxide levels
- Heavy metals
Correct answer: Water content
Karl Fischer titration is a specific method for determining water content (moisture) in pharmaceutical samples.
Question 3: What does the term 'robustness' mean in the context of analytical method validation?
- Ability to detect trace impurities
- Measure of method capacity to remain unaffected by small deliberate variations (Correct answer)
- Degree of agreement between repeated measurements
- Range of concentrations accurately measured
Correct answer: Measure of method capacity to remain unaffected by small deliberate variations
Robustness measures how an analytical method performs when subjected to small, intentional changes in method parameters.
Question 4: Which technique is most appropriate for quantifying residual solvents in pharmaceutical products per ICH Q3C?
- HPLC-UV
- Headspace GC (Correct answer)
- UV-Vis spectrophotometry
- Atomic absorption spectroscopy
Correct answer: Headspace GC
Headspace gas chromatography is the recommended technique for detecting and quantifying volatile residual solvents in pharmaceuticals.
Question 5: In dissolution testing, what does the parameter 'f2 similarity factor' evaluate?
- Drug potency relative to reference standard
- Similarity of dissolution profiles between two products (Correct answer)
- Degree of supersaturation in dissolution media
- Rate constant of drug release
Correct answer: Similarity of dissolution profiles between two products
The f2 similarity factor (≥50 indicates similarity) compares dissolution profiles of a test and reference product.
Question 6: What is the role of a blank in spectrophotometric analysis?
- It provides the maximum absorbance reference
- It corrects for background absorbance of the solvent or reagents (Correct answer)
- It establishes the upper limit of the calibration curve
- It calibrates the detector wavelength
Correct answer: It corrects for background absorbance of the solvent or reagents
A blank contains all reagents except the analyte and is used to zero the instrument, correcting for background absorption.
Question 7: Which quality attribute is directly assessed by the Friability test in tablet manufacturing?
- Tablet hardness under compression
- Weight uniformity of the batch
- Resistance to surface abrasion and chipping (Correct answer)
- Disintegration time in GI fluid
Correct answer: Resistance to surface abrasion and chipping
The friability test measures the percentage weight loss of tablets due to mechanical stress such as tumbling and abrasion.
