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.
MPharm Master of Pharmacy Master of Pharmacy: Pharmaceutical Analysis and Quality Control 2
Which ICH guideline specifically addresses validation of analytical procedures for pharmaceutical use?