Accelerated stability testing MCQs With Answer

Accelerated stability testing MCQs With Answer

Accelerated stability testing is a targeted approach B.Pharm students must master to predict drug product shelf-life by exposing formulations to elevated temperature and humidity. Guided by ICH guidelines, accelerated studies use controlled stress conditions (commonly 40°C/75% RH), stability chambers, defined sampling schedules and kinetic models, including the Arrhenius equation and mean kinetic temperature, to estimate degradation rates. Understanding study design, sample handling, analytical method validation, packaging effects, forced degradation and photostability helps interpret results and set storage conditions and expiry. This topic links physical‑chemical degradation pathways with regulatory expectations, quality assurance principles and practical lab techniques. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which ICH guideline specifically provides recommendations for stability testing of new drug substances and products?

• ICH Q1A(R2)
• ICH Q2(R1)
• ICH Q3A(R2)
• ICH Q5C

Correct Answer: ICH Q1A(R2)

Q2. What are the common accelerated stability test conditions for many pharmaceutical products?

• 25°C / 60% RH
• 30°C / 65% RH
• 40°C / 75% RH
• 50°C / 95% RH

Correct Answer: 40°C / 75% RH

Q3. Which concept is used to represent the effect of temperature history on product degradation in accelerated testing?

• Mean kinetic temperature
• Thermal equilibrium constant
• Relative degradation index
• Humidity factor

Correct Answer: Mean kinetic temperature

Q4. Accelerated stability testing primarily helps to:

• Identify impurities unrelated to storage
• Predict long-term shelf-life by extrapolating degradation rates
• Replace all long-term studies completely
• Test only microbiological stability

Correct Answer: Predict long-term shelf-life by extrapolating degradation rates

Q5. Forced degradation studies differ from accelerated stability studies because forced degradation:

• Uses milder conditions than accelerated tests
• Is intended to identify degradation pathways under exaggerated conditions
• Is used solely to determine expiration dates
• Is performed only at room temperature

Correct Answer: Is intended to identify degradation pathways under exaggerated conditions

Q6. Which equation is commonly applied to relate reaction rate constants to temperature in stability kinetics?

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

Correct Answer: Arrhenius equation

Q7. A stability-indicating analytical method must:

• Only quantify assay without separating degradation products
• Detect and quantify the drug in presence of impurities and degradation products
• Be qualitative only
• Be independent of validation

Correct Answer: Detect and quantify the drug in presence of impurities and degradation products

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

• ICH Q1B
• ICH Q1C
• ICH Q2
• ICH Q3B

Correct Answer: ICH Q1B

Q9. Mean kinetic temperature (MKT) is useful because it:

• Gives the arithmetic mean of storage temperatures
• Weights higher temperatures more heavily to reflect chemical degradation
• Is identical to the highest recorded temperature
• Is only applicable to sterile products

Correct Answer: Weights higher temperatures more heavily to reflect chemical degradation

Q10. In an accelerated study, sampling intervals are chosen primarily to:

• Match routine laboratory workload
• Capture degradation kinetics and identify significant changes over time
• Minimize analytical costs
• Avoid detection of degradation products

Correct Answer: Capture degradation kinetics and identify significant changes over time

Q11. Which factor is LEAST likely to influence accelerated stability results?

• Packaging material and closure
• Analytical method sensitivity
• Room lighting in the building lobby
• Initial formulation pH

Correct Answer: Room lighting in the building lobby

Q12. Extrapolation of shelf-life from accelerated data using Arrhenius kinetics assumes:

• The degradation mechanism remains constant across temperatures
• Different mechanisms occur at each temperature
• Humidity has no effect on degradation
• Photolytic degradation dominates

Correct Answer: The degradation mechanism remains constant across temperatures

Q13. Which analytical parameter is critical to show a method is stability-indicating?

• Selectivity or specificity for the drug peak in presence of degradants
• Low cost of reagents
• Short analysis time only
• Colorimetric response

Correct Answer: Selectivity or specificity for the drug peak in presence of degradants

Q14. Humidity is particularly important in accelerated testing for which dosage form?

• Tablets with hygroscopic excipients
• Compressed metal implants
• Glass vials only
• Inert polymer beads without moisture sensitivity

Correct Answer: Tablets with hygroscopic excipients

Q15. Which outcome from accelerated testing may require changes to packaging?

• Improved dissolution profile at high temperature
• Significant moisture-induced degradation in open trays
• Analytical method robustness
• Unchanged assay over time

Correct Answer: Significant moisture-induced degradation in open trays

Q16. Photostability testing assesses:

• Thermal stability only
• Product response to light exposure and potential photodegradation
• Microbial contamination after light exposure
• Packaging sealing integrity

Correct Answer: Product response to light exposure and potential photodegradation

Q17. Which storage condition is considered “accelerated” for stability studies of drug products intended for long-term storage at 25°C?

• 5°C / refrigerate
• Room temperature without RH control
• 40°C / 75% RH controlled
• Ambient uncontrolled

Correct Answer: 40°C / 75% RH controlled

Q18. During accelerated stability testing, the term “acceptance criteria” refers to:

• Predefined limits for potency, impurities and physical attributes
• Only the visual appearance standard
• Unvalidated targets that can be changed anytime
• Manufacturer’s internal notes not used in reports

Correct Answer: Predefined limits for potency, impurities and physical attributes

Q19. Which experimental design element reduces variability in accelerated stability studies?

• Randomizing sample positions in stability chambers
• Using different analytical methods each time
• Changing chamber conditions mid-study
• Pooling all time point samples into one analysis

Correct Answer: Randomizing sample positions in stability chambers

Q20. Which of the following is a common sign of chemical degradation observed during stability testing?

• New impurity peaks in chromatograms
• Increase in tablet hardness only
• Sterility test failure unrelated to chemistry
• Unchanged assay and impurity profile

Correct Answer: New impurity peaks in chromatograms

Q21. Stability chambers used for accelerated testing must control:

• Only temperature
• Only humidity
• Temperature and humidity
• Neither temperature nor humidity

Correct Answer: Temperature and humidity

Q22. Which is TRUE about extrapolating shelf-life from accelerated studies when degradation is zero-order?

• Arrhenius analysis is not applicable at all
• Degradation rate is constant and shelf-life is calculated from a linear decrease
• Extrapolation always underestimates shelf-life
• Only photostability data can be used

Correct Answer: Degradation rate is constant and shelf-life is calculated from a linear decrease

Q23. What role do antioxidants and preservatives play in accelerated stability studies?

• They are irrelevant to chemical stability
• They can mitigate oxidative degradation and microbial growth, affecting stability outcomes
• They always accelerate degradation
• They replace the need for packaging

Correct Answer: They can mitigate oxidative degradation and microbial growth, affecting stability outcomes

Q24. Which test is most appropriate to evaluate moisture uptake during accelerated humidity conditions?

• Water vapour transmission rate of packaging
• Assay by HPLC only
• Particle size analysis only
• Disintegration in non-aqueous medium

Correct Answer: Water vapour transmission rate of packaging

Q25. Regulatory accelerated stability data are often used to:

• Support initial shelf-life assignment for marketed products
• Replace all long-term stability commitments
• Determine pricing strategy
• Evaluate patient acceptability

Correct Answer: Support initial shelf-life assignment for marketed products

Q26. Which statement about accelerated testing for biologics is correct?

• Biologics always follow the same temperature conditions as small molecules
• Biologics often require specialized conditions and may be more sensitive to temperature/humidity
• Accelerated testing is not needed for biologics
• Photostability is the only concern for biologics

Correct Answer: Biologics often require specialized conditions and may be more sensitive to temperature/humidity

Q27. Which parameter is typically monitored to assess physical stability of tablets during accelerated testing?

• Color, hardness and dissolution profile
• Only moisture content without other tests
• pH of the tablet core in all cases
• Optical rotation only

Correct Answer: Color, hardness and dissolution profile

Q28. When stability data show non-linear Arrhenius behavior, the most appropriate action is to:

• Proceed with extrapolation regardless
• Investigate mechanism changes and consider additional studies or models
• Ignore the accelerated data and only use long-term data
• Assume product is stable indefinitely

Correct Answer: Investigate mechanism changes and consider additional studies or models

Q29. Which piece of documentation is essential when reporting accelerated stability results to regulators?

• Raw chromatograms, stability protocol, and detailed data analysis
• Only a brief summary email
• Only photos of samples
• Price lists of reagents used

Correct Answer: Raw chromatograms, stability protocol, and detailed data analysis

Q30. What is a key limitation of accelerated stability testing?

• It always provides a precise shelf-life without uncertainty
• It may not predict long-term behavior if degradation mechanisms change under extreme conditions
• It eliminates the need for analytical method validation
• It is cheaper than analytical testing

Correct Answer: It may not predict long-term behavior if degradation mechanisms change under extreme conditions