Stability testing in product development MCQs With Answer

Introduction: Stability testing in product development MCQs With Answer is designed for M.Pharm students to build a strong, practical understanding of stability studies as applied during pharmaceutical product development and technology transfer. This set covers ICH guidelines, stress and forced degradation, accelerated/intermediate/long-term protocols, photostability, container-closure effects, statistical interpretation, kinetics (including Arrhenius applications), and regulatory expectations. Each question focuses on real-world decisions made during formulation optimization, analytical method development, shelf-life assignment and post-approval commitments. Use these MCQs to test conceptual knowledge and problem-solving skills needed to design robust stability programs that ensure product safety, efficacy and quality throughout its shelf life.

Q1. What is the primary objective of stability testing during pharmaceutical product development?

• To evaluate marketing strategies for the product
• To determine the physicochemical, microbiological, and therapeutic stability to establish shelf life, storage conditions and labeling
• To compare manufacturing costs among different sites
• To test patient acceptance and preference

Correct Answer: To determine the physicochemical, microbiological, and therapeutic stability to establish shelf life, storage conditions and labeling

Q2. Which ICH guideline specifically addresses stability testing of new drug substances and products?

• ICH Q3A (Impurities)
• ICH Q1A (R2) Stability Testing of New Drug Substances and Products
• ICH Q5C (Biotechnological Products)
• ICH Q9 (Quality Risk Management)

Correct Answer: ICH Q1A (R2) Stability Testing of New Drug Substances and Products

Q3. According to common ICH long-term storage conditions for Zone II (temperate) climates, what are the standard conditions used for accelerated shelf-life assignment?

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

Correct Answer: 25°C ±2°C / 60% RH ±5% RH

Q4. What are the ICH-recommended conditions for accelerated stability testing of most non-refrigerated products?

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

Correct Answer: 40°C ±2°C / 75% RH ±5% RH

Q5. Which guideline covers photostability testing of new drug substances and products?

• ICH Q1A
• ICH Q3B
• ICH Q1B Photostability Testing of New Drug Substances and Products
• ICH Q6A

Correct Answer: ICH Q1B Photostability Testing of New Drug Substances and Products

Q6. What is the main purpose of forced degradation (stress testing) in method development?

• To shorten regulatory review times
• To create degradation products to ensure the analytical method is stability-indicating and to understand degradation pathways
• To evaluate patient compliance under worst-case use
• To validate manufacturing equipment

Correct Answer: To create degradation products to ensure the analytical method is stability-indicating and to understand degradation pathways

Q7. A stability-indicating assay is best described as which of the following?

• An assay that only measures impurities
• An assay that can fully separate and quantify the active pharmaceutical ingredient in presence of degradation products and excipients
• An assay used exclusively for dissolution testing
• An assay that estimates product yield during manufacturing

Correct Answer: An assay that can fully separate and quantify the active pharmaceutical ingredient in presence of degradation products and excipients

Q8. Which statement correctly describes the Arrhenius equation’s role in stability studies?

• It correlates humidity to dissolution rate
• It predicts the temperature dependence of the degradation rate constant to estimate shelf-life
• It defines acceptable impurity limits
• It specifies photostability exposure levels

Correct Answer: It predicts the temperature dependence of the degradation rate constant to estimate shelf-life

Q9. For a drug that follows first-order degradation kinetics with a rate constant k = 0.002 day⁻¹ at 25°C, what is the approximate t90 (time for 10% degradation, i.e., 90% remaining)?

• ~5 days
• ~50 days
• ~500 days
• ~5000 days

Correct Answer: ~50 days

Q10. What is the concept of bracketing in stability study design?

• Testing only the smallest packaging size in stability studies
• Testing only the extremes of certain design factors (e.g., strength, container size) to reduce the number of samples
• Testing every possible combination of strength and packaging
• Testing only in accelerated conditions and extrapolating all data

Correct Answer: Testing only the extremes of certain design factors (e.g., strength, container size) to reduce the number of samples

Q11. Matrixing in stability testing is best defined as:

• Designing studies to test subsets of samples at selected time points to reduce workload while maintaining representative coverage
• Full testing of all strengths and container sizes at all time points
• Only performing accelerated stability tests
• Using statistical software to simulate degradation

Correct Answer: Designing studies to test subsets of samples at selected time points to reduce workload while maintaining representative coverage

Q12. Which of the following storage factors is most likely to accelerate hydrolytic degradation of a moisture-sensitive drug product?

• Opaque primary container protecting from light
• High relative humidity and permeable container closure system
• Low temperature refrigeration
• Nitrogen-filled headspace with desiccant

Correct Answer: High relative humidity and permeable container closure system

Q13. Photostability testing as per ICH Q1B requires exposure to which minimum levels of light?

• 1.2 million lux hours of visible light and 200 watt-hours/m² of near UV energy
• 500,000 lux hours and 50 watt-hours/m² UV
• No specific light exposure is recommended
• Only direct sunlight exposure for 24 hours

Correct Answer: 1.2 million lux hours of visible light and 200 watt-hours/m² of near UV energy

Q14. Which outcome from an accelerated stability study is typically required before a product can be labeled with a long-term shelf life?

• Only single-point assay at time zero
• No change at accelerated conditions is required; long-term data are primarily used to assign shelf life
• Complete absence of any degradation products at accelerated conditions
• Microbial load increase within limits but no chemical evaluation

Correct Answer: No change at accelerated conditions is required; long-term data are primarily used to assign shelf life

Q15. Forced degradation studies typically include which of the following stress conditions?

• Thermal, photolytic, oxidative, hydrolytic (acid/base) and sometimes enzymatic degradation
• Only thermal stress
• Only microbial challenge tests
• Only long-term storage at labelled conditions

Correct Answer: Thermal, photolytic, oxidative, hydrolytic (acid/base) and sometimes enzymatic degradation

Q16. In the context of API versus finished product, what does a ‘retest period’ refer to?

• The shelf life assigned to the finished packaged product
• The period after which an active pharmaceutical ingredient should be retested to confirm it still meets acceptance criteria before use in manufacturing
• The time between product recalls
• The time allowed for stability chamber maintenance

Correct Answer: The period after which an active pharmaceutical ingredient should be retested to confirm it still meets acceptance criteria before use in manufacturing

Q17. For sterile parenteral products, which additional stability attribute is critically assessed compared with non-sterile solids?

• Color only
• Maintenance of sterility and endotoxin/bioburden control over shelf life
• Tablet disintegration
• Capsule brittleness

Correct Answer: Maintenance of sterility and endotoxin/bioburden control over shelf life

Q18. How long is a typical accelerated stability study conducted under ICH Q1A to provide supportive information for shelf-life assignment?

• 2 weeks
• 3 months
• 6 months
• 24 months

Correct Answer: 6 months

Q19. Which statement best reflects stability considerations for biological (biotech) products compared with small-molecule drugs?

• Biologicals are generally less sensitive to temperature and do not require cold chain
• Biologicals require specific potency, aggregation, and structural integrity assays with often stricter temperature control and different degradation pathways
• Biologicals can use the same simple HPLC assay used for small molecules
• Biologicals do not require container-closure studies

Correct Answer: Biologicals require specific potency, aggregation, and structural integrity assays with often stricter temperature control and different degradation pathways

Q20. Which of the following is a suitable justification for using accelerated stability data to predict long-term shelf life?

• Degradation follows predictable kinetics and an appropriate model (e.g., Arrhenius) has been validated for extrapolation
• The product shows no change at any condition, so modeling is unnecessary
• Accelerated data always directly equals long-term results without modeling
• Stability can be predicted solely from formulation composition without testing

Correct Answer: Degradation follows predictable kinetics and an appropriate model (e.g., Arrhenius) has been validated for extrapolation

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