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
Which ICH guideline specifically addresses validation of analytical procedures for pharmaceutical use?
Answer: ICH Q2(R1)
ICH Q2(R1) defines validation characteristics such as specificity, linearity, accuracy, and precision for analytical methods.
In Karl Fischer titration, what is the primary analyte being quantified?
Answer: Water content
Karl Fischer titration is a specific method for determining water content (moisture) in pharmaceutical samples.
What does the term 'robustness' mean in the context of analytical method validation?
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.
Which technique is most appropriate for quantifying residual solvents in pharmaceutical products per ICH Q3C?
Answer: Headspace GC
Headspace gas chromatography is the recommended technique for detecting and quantifying volatile residual solvents in pharmaceuticals.
In dissolution testing, what does the parameter 'f2 similarity factor' evaluate?
Answer: Similarity of dissolution profiles between two products
The f2 similarity factor (≥50 indicates similarity) compares dissolution profiles of a test and reference product.
What is the role of a blank in spectrophotometric analysis?
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.
Which quality attribute is directly assessed by the Friability test in tablet manufacturing?
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.