Packing, storage and stability testing of capsules covers critical concepts B.Pharm students must master to ensure capsule quality, efficacy and shelf life. This topic explores packaging materials (PVC, PVDC, aluminum, glass, HDPE), capsule types (gelatin, HPMC), moisture and temperature effects, desiccants, barrier properties, and regulatory stability requirements (ICH Q1A, Q1B). It also addresses stability study design—accelerated, intermediate and long‑term conditions—stability‑indicating methods, degradation pathways, photostability, shelf‑life estimation and packaging validation. Understanding interactions between formulation, packaging and environment is essential for reliable product performance and regulatory submissions. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary purpose of protective packing for oral capsules?
- To improve taste of the drug
- To provide a moisture and physical barrier to maintain quality
- To change the color of capsules
- To reduce manufacturing cost
Correct Answer: To provide a moisture and physical barrier to maintain quality
Q2. Which packaging material offers the best overall moisture and light barrier for blister-packed capsules?
- PVC (polyvinyl chloride) blister
- PVC/PVDC coated blister
- Alu‑Alu (aluminium foil) blister
- Cardboard box
Correct Answer: Alu‑Alu (aluminium foil) blister
Q3. Which capsule shell material is most sensitive to ambient humidity changes?
- HPMC (hydroxypropyl methylcellulose) capsules
- Gelatin capsules
- Cellulose acetate capsules
- Polyethylene capsules
Correct Answer: Gelatin capsules
Q4. Which of the following is NOT usually evaluated during stability testing of capsules?
- Assay of active ingredient
- Dissolution profile
- Color of packaging cardboard
- Microbial limit or bioburden
Correct Answer: Color of packaging cardboard
Q5. According to ICH guidelines, typical accelerated stability conditions are:
- 5°C ± 3°C and 30% RH
- 25°C ± 2°C and 60% RH
- 40°C ± 2°C and 75% RH
- 60°C ± 5°C and 90% RH
Correct Answer: 40°C ± 2°C and 75% RH
Q6. Which test specifically assesses susceptibility of a capsule product to light-induced degradation?
- Forced‑degradation under acidic conditions
- Photostability testing as per ICH Q1B
- Microbial challenge test
- Disintegration test
Correct Answer: Photostability testing as per ICH Q1B
Q7. What is the role of a desiccant in capsule packaging?
- To act as a buffer for pH
- To absorb moisture and protect hygroscopic capsules
- To increase the weight of the container
- To act as a lubricant during capsule filling
Correct Answer: To absorb moisture and protect hygroscopic capsules
Q8. Which desiccant is commonly used in capsule bottles?
- Sodium chloride
- Silica gel
- Sucrose
- Polyvinyl alcohol
Correct Answer: Silica gel
Q9. For long-term stability studies for products intended for storage in temperate climates, the ICH long-term condition is typically:
- 25°C ± 2°C and 60% RH ± 5% RH
- 40°C ± 2°C and 75% RH
- 5°C ± 3°C and ambient RH
- 30°C ± 2°C and 35% RH
Correct Answer: 25°C ± 2°C and 60% RH ± 5% RH
Q10. Which of the following stability-indicating parameters detects chemical degradation of the active ingredient over time?
- Disintegration time only
- Assay and impurity profiling by a validated HPLC method
- Package color measurement
- Physical weight of the tablet
Correct Answer: Assay and impurity profiling by a validated HPLC method
Q11. What is the primary reason to perform forced degradation (stress testing) on a capsule formulation?
- To optimize taste masking
- To identify likely degradation products and develop stability‑indicating assays
- To reduce manufacturing time
- To improve capsule filling efficiency
Correct Answer: To identify likely degradation products and develop stability‑indicating assays
Q12. Which packaging test verifies that blister seal integrity prevents moisture ingress?
- Friability test
- Dye penetration or vacuum leak test
- Disintegration test
- Organoleptic test
Correct Answer: Dye penetration or vacuum leak test
Q13. Which analytical approach is commonly used to estimate the effect of temperature on degradation rate for shelf-life prediction?
- Henderson-Hasselbalch equation
- Arrhenius equation
- Beer-Lambert law
- Nernst equation
Correct Answer: Arrhenius equation
Q14. Which packaging choice is preferred when capsules are highly moisture-sensitive and require low water vapor transmission?
- Uncoated PVC blister
- Paper pouch
- Alu‑Alu blister or glass bottle with desiccant
- Thin cardboard sleeve
Correct Answer: Alu‑Alu blister or glass bottle with desiccant
Q15. What does the term “shelf life” of a capsule product mean?
- Time until the product changes color
- Time during which the product remains within established specifications when stored under defined conditions
- Time required to manufacture the capsules
- Time taken for dissolution testing
Correct Answer: Time during which the product remains within established specifications when stored under defined conditions
Q16. Which ICH guideline specifically addresses photostability testing of new drug substances and products?
- ICH Q1A(R2)
- ICH Q1B
- ICH Q3A
- ICH Q5C
Correct Answer: ICH Q1B
Q17. For a capsule stored in a HDPE bottle, which factor most reduces moisture ingress?
- Using a taller bottle
- Including an effective desiccant and tight child-resistant closure
- Packing more capsules in the bottle
- Printing a colored label
Correct Answer: Including an effective desiccant and tight child-resistant closure
Q18. Which of the following is a common physical instability observed in gelatin capsules under high humidity?
- Capsules become brittle and crack
- Capsules become soft, tacky and may agglomerate
- Capsules dissolve immediately
- Capsules increase potency
Correct Answer: Capsules become soft, tacky and may agglomerate
Q19. What does “bracketing and matrixing” in stability study design aim to achieve?
- To minimize number of samples and time points while covering critical combinations of strengths, container sizes and conditions
- To maximize packaging materials used
- To avoid the use of stability chambers
- To increase product viscosity
Correct Answer: To minimize number of samples and time points while covering critical combinations of strengths, container sizes and conditions
Q20. Which microbial test is especially important for multi-dose capsule bottles?
- Sterility test for non-sterile product
- Total aerobic microbial count / TAMC and specified organisms
- Endotoxin test only
- pH test
Correct Answer: Total aerobic microbial count / TAMC and specified organisms
Q21. During stability testing, a change in dissolution profile over time most likely indicates:
- Change in disintegration or API availability due to degradation, excipient interaction or packaging influence
- A problem with antimicrobial preservative
- Only color change in label
- Improved bioavailability always
Correct Answer: Change in disintegration or API availability due to degradation, excipient interaction or packaging influence
Q22. Which of the following is a key consideration when selecting primary packaging for capsules?
- Color of the manufacturing plant
- Barrier properties, chemical compatibility and convenience for patient use
- Length of conveyor belts
- Number of suppliers for printing inks
Correct Answer: Barrier properties, chemical compatibility and convenience for patient use
Q23. What is the main purpose of an accelerated stability study?
- To determine color preferences of patients
- To quickly identify likely degradation pathways and estimate shelf life under stress conditions
- To reduce packaging costs
- To replace long-term studies entirely
Correct Answer: To quickly identify likely degradation pathways and estimate shelf life under stress conditions
Q24. In stability testing documentation, what is the significance of a stability protocol?
- It outlines the detailed study plan, sampling points, tests, storage conditions and acceptance criteria
- It is only used for marketing
- It replaces analytical method validation
- It defines the product label design
Correct Answer: It outlines the detailed study plan, sampling points, tests, storage conditions and acceptance criteria
Q25. Which packaging closure feature helps to maintain capsule stability by limiting moisture exchange?
- Perforated cap
- Liners, induction seals and tamper-evident closures
- Loose-fitting cap
- Cap with ventilation holes
Correct Answer: Liners, induction seals and tamper-evident closures
Q26. Which measurement is most directly used to monitor moisture uptake in capsules during stability studies?
- pH measurement
- Loss on drying or Karl Fischer titration for water content
- Colorimetric assay
- Friability alone
Correct Answer: Loss on drying or Karl Fischer titration for water content
Q27. When transferring a capsule product to a new packaging material, what is required to ensure stability is maintained?
- No testing; assume same stability
- Comparative stability and compatibility studies demonstrating equivalent protection
- Only a visual inspection of the new package
- Change the label only
Correct Answer: Comparative stability and compatibility studies demonstrating equivalent protection
Q28. Which of the following is a common outcome of oxygen-sensitive API packaged without oxygen barrier?
- Enhanced dissolution
- Oxidative degradation leading to impurity formation and potency loss
- Improved capsule color stability
- Lower microbial contamination
Correct Answer: Oxidative degradation leading to impurity formation and potency loss
Q29. Which analytical attribute must a stability-indicating method demonstrate?
- Selectivity to separate API from degradation products and quantify changes over time
- Only measure pH
- Only measure fragrance
- Only measure capsule size
Correct Answer: Selectivity to separate API from degradation products and quantify changes over time
Q30. For statistical evaluation of stability data and shelf-life assignment, which practice is commonly used?
- Ignoring out-of-specification results
- Trend analysis using regression and applying acceptance limits to predict time to failure
- Using only single-point measurements
- Setting arbitrary shelf life without data
Correct Answer: Trend analysis using regression and applying acceptance limits to predict time to failure
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
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