MPharm Master of Pharmacy Master of Pharmacy: Pharmaceutical Analysis and Quality Control 4

Question 1

In mass spectrometry, what does 'base peak' refer to?

Accepted Answer

The most abundant ion fragment in the spectrum (set to 100% relative abundance)

Answer

The base peak is the most intense ion in the mass spectrum, assigned 100% relative abundance, against which all other peaks are compared.

Question 2

What is the primary purpose of using an internal standard in analytical methods like HPLC or GC?

Accepted Answer

To compensate for variability in sample preparation and instrument response

Answer

An internal standard is added at a known concentration to correct for losses and variability during sample preparation and injection.

Question 3

Which USP test specifically evaluates particulate contamination in injectable pharmaceutical preparations?

Accepted Answer

Light obscuration particle count test

Answer

The light obscuration particle count test (USP <788>) measures subvisible particles in injectable solutions using laser-based detection.

Question 4

In pharmaceutical stability testing per ICH Q1A, what storage condition defines 'accelerated' stability testing for Zone IV climatic conditions?

Accepted Answer

40°C ± 2°C / 75% RH ± 5%

Answer

Accelerated stability testing for products intended for hot/humid climates (Zone IV) is conducted at 40°C/75% RH for 6 months.

Question 5

What analytical principle underlies the Kjeldahl method used in pharmaceutical analysis?

Accepted Answer

Acid digestion followed by distillation to determine nitrogen content

Answer

The Kjeldahl method digests organic nitrogen with sulfuric acid, converts it to ammonium, then distills and titrates to quantify total nitrogen.

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