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 mass spectrometry, what does 'base peak' refer to?
Answer: The most abundant ion fragment in the spectrum (set to 100% relative abundance)
The base peak is the most intense ion in the mass spectrum, assigned 100% relative abundance, against which all other peaks are compared.
What is the primary purpose of using an internal standard in analytical methods like HPLC or GC?
Answer: To compensate for variability in sample preparation and instrument response
An internal standard is added at a known concentration to correct for losses and variability during sample preparation and injection.
Which USP test specifically evaluates particulate contamination in injectable pharmaceutical preparations?
Answer: Light obscuration particle count test
The light obscuration particle count test (USP ) measures subvisible particles in injectable solutions using laser-based detection.
In pharmaceutical stability testing per ICH Q1A, what storage condition defines 'accelerated' stability testing for Zone IV climatic conditions?
Answer: 40°C ± 2°C / 75% RH ± 5%
Accelerated stability testing for products intended for hot/humid climates (Zone IV) is conducted at 40°C/75% RH for 6 months.
What analytical principle underlies the Kjeldahl method used in pharmaceutical analysis?
Answer: Acid digestion followed by distillation to determine nitrogen content
The Kjeldahl method digests organic nitrogen with sulfuric acid, converts it to ammonium, then distills and titrates to quantify total nitrogen.
In FTIR spectroscopy, what is the purpose of the 'fingerprint region' (400–1500 cm⁻¹)?
Answer: Unique molecular identification through complex vibrational patterns
The fingerprint region contains unique, complex absorption patterns that serve as a molecular 'fingerprint' for identity confirmation of pharmaceutical substances.
What does 'limit of detection' (LOD) represent in analytical method validation?
Answer: The lowest concentration reliably distinguished from zero signal (signal-to-noise ≈ 3:1)
LOD is the smallest analyte concentration distinguishable from background noise, typically estimated at a signal-to-noise ratio of 3:1.