Stability Testing Protocols: Batch selection, storage conditions, sampling and shelf-life calculation MCQs With Answer

This quiz collection focuses on stability testing protocols — batch selection, storage conditions, sampling strategies, and shelf-life calculation — tailored for M.Pharm students studying Advanced Pharmaceutical Analysis (MPA 102T). It covers regulatory expectations (ICH guidelines), practical design choices such as bracketing and matrixing, worst-case selection for container-closure systems, typical storage conditions for different climatic zones, sampling schedules, stress and photostability testing, and statistical approaches for shelf-life estimation. Each question is designed to test conceptual understanding and application in formulation development and regulatory submissions, helping students prepare for exams and real-world stability study design and data interpretation.

Q1. Which ICH guideline primarily governs stability testing of new drug substances and products?

• ICH Q1A(R2)
• ICH Q6A
• ICH Q8(R2)
• ICH Q7

Correct Answer: ICH Q1A(R2)

Q2. According to regulatory guidance, what is the minimum recommended number of batches for long-term stability studies of a new drug product?

• One full-scale batch
• Two pilot-scale batches
• Three production-scale batches
• Five laboratory-scale batches

Correct Answer: Three production-scale batches

Q3. What best describes the concept of “bracketing” in stability study design?

• Testing all strengths and container sizes at every time point
• Testing only the extremes of certain factors (e.g., strengths, container sizes) during a study
• Testing a random subset of batches across all conditions
• Conducting only accelerated studies and extrapolating to long-term

Correct Answer: Testing only the extremes of certain factors (e.g., strengths, container sizes) during a study

Q4. What does “matrixing” refer to in stability testing?

• Testing only drug substance and ignoring the finished product
• Testing each time point with all possible analytical tests
• Testing different subsets of samples at different time points to reduce testing burden
• Applying accelerated conditions across all batches

Correct Answer: Testing different subsets of samples at different time points to reduce testing burden

Q5. What are the standard accelerated stability conditions recommended by ICH for most drug products?

• 25 ± 2°C / 60 ± 5% RH
• 40 ± 2°C / 75 ± 5% RH
• 30 ± 2°C / 65 ± 5% RH
• 5 ± 3°C (refrigerated)

Correct Answer: 40 ± 2°C / 75 ± 5% RH

Q6. Which is a typical long-term storage condition for products intended for climatic Zone II?

• 30 ± 2°C / 65 ± 5% RH
• 40 ± 2°C / 75 ± 5% RH
• 25 ± 2°C / 60 ± 5% RH
• 5 ± 3°C

Correct Answer: 25 ± 2°C / 60 ± 5% RH

Q7. When is intermediate stability testing recommended?

• Only when photostability testing fails
• When accelerated conditions indicate significant change before proposed shelf-life
• For products stored below 0°C
• For all products regardless of accelerated study results

Correct Answer: When accelerated conditions indicate significant change before proposed shelf-life

Q8. Which guideline specifically addresses photostability testing of new drug substances and products?

• ICH Q1A(R2)
• ICH Q1B
• ICH Q2(R1)
• ICH Q3B

Correct Answer: ICH Q1B

Q9. For worst-case selection of container-closure systems, which container would typically be chosen?

• The container with the most aesthetically pleasing design
• The primary packaging with the highest potential to affect product stability (e.g., highest permeability)
• The smallest available container size regardless of material
• The container used for clinical trial supply only

Correct Answer: The primary packaging with the highest potential to affect product stability (e.g., highest permeability)

Q10. What is a commonly accepted minimum number of replicate containers to be tested per time point for physical/chemical assays in a stability study?

• One container is sufficient
• At least two containers
• At least three containers per time point to allow replicate testing
• Ten containers per time point

Correct Answer: At least three containers per time point to allow replicate testing

Q11. According to statistical approaches in stability (ICH Q1E), how is shelf-life often estimated from linear regression of potency versus time?

• Time when the mean potency equals zero
• Time when the upper 95% confidence limit intersects the specification limit
• Time when the lower 95% confidence limit from the regression intersects the acceptance criterion
• The average time to first out-of-specification result

Correct Answer: Time when the lower 95% confidence limit from the regression intersects the acceptance criterion

Q12. In first-order degradation kinetics, which plot gives a straight line?

• Concentration vs time
• ln(concentration) vs time
• 1/concentration vs time
• Square root of concentration vs time

Correct Answer: ln(concentration) vs time

Q13. What does the Q10 temperature coefficient approximately represent in stability predictions?

• Rate decreases by a factor of ten every 10°C rise
• Rate doubles for every 10°C rise (Q10 ≈ 2)
• Rate remains unchanged with temperature
• Rate becomes half for each 10°C rise

Correct Answer: Rate doubles for every 10°C rise (Q10 ≈ 2)

Q14. Which mathematical relationship is commonly used to relate degradation rate constants to temperature for accelerated stability extrapolation?

• Henderson-Hasselbalch equation
• Arrhenius equation
• Michaelis-Menten equation
• van’t Hoff equation for solubility only

Correct Answer: Arrhenius equation

Q15. Typical long-term stability sampling intervals recommended for many products include which sequence?

• 0, 1, 2, 3 months
• 0, 3, 6, 9, 12, 18, 24, 36 months
• Only 0 and final time point
• Every month up to 60 months

Correct Answer: 0, 3, 6, 9, 12, 18, 24, 36 months

Q16. Which statement is true about extrapolating shelf-life from accelerated data alone?

• Extrapolation is always acceptable without qualification
• Shelf-life extrapolated solely from accelerated data requires justification and supporting evidence from real-time data or mechanistic understanding
• Accelerated data can never be used for any shelf-life estimation
• Accelerated studies replace the need for long-term studies

Correct Answer: Shelf-life extrapolated solely from accelerated data requires justification and supporting evidence from real-time data or mechanistic understanding

Q17. What is a core requirement for a stability-indicating analytical method?

• High throughput without specificity
• Ability to separate and quantify the drug substance from its degradation products
• Only to measure impurities at release
• Exclusive use of UV detection methods

Correct Answer: Ability to separate and quantify the drug substance from its degradation products

Q18. The term “retest period” typically applies to which material?

• Finished dosage form (drug product)
• Active Pharmaceutical Ingredient (API)
• Packaging components only
• Placebo formulations

Correct Answer: Active Pharmaceutical Ingredient (API)

Q19. According to ICH Q1B, what are the recommended overall illumination and UV energy exposures for photostability testing?

• 200 lux hours and 1,000 watt-hours/m2 UV energy
• 1.2 million lux hours and 200 watt-hours/m2 UV energy
• 500,000 lux hours and 50 watt-hours/m2 UV energy
• No specific numerical exposures are provided

Correct Answer: 1.2 million lux hours and 200 watt-hours/m2 UV energy

Q20. What is the primary purpose of conducting stress (forced degradation) studies during drug development?

• To determine product color preferences
• To identify degradation pathways and help develop stability-indicating methods
• To replace long-term stability testing
• To test product palatability under extreme conditions

Correct Answer: To identify degradation pathways and help develop stability-indicating methods

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