MCQ on Storage Conditions and Drug Stability

🟢 Easy (1–20)

1. What is the commonly recommended temperature range for storing refrigerated drugs?
   A. -20°C to -10°C
   B. 2°C to 8°C ✅
   C. 8°C to 15°C
   D. 15°C to 25°C
   Explanation: Refrigerated drugs are typically stored between 2°C and 8°C.
2. Room temperature for drug storage generally refers to:
   A. 5°C–10°C
   B. 10°C–20°C
   C. 20°C–25°C ✅
   D. 25°C–30°C
   Explanation: Room temperature is defined as 20°C to 25°C for pharmaceutical storage.
3. Which factor does NOT affect drug stability?
   A. Light
   B. Moisture
   C. Temperature
   D. Taste ✅
   Explanation: Taste is a sensory attribute, not a stability factor.
4. Drugs that are sensitive to light should be stored in:
   A. Transparent containers
   B. Clear plastic bags
   C. Amber-colored containers ✅
   D. Glass jars
   Explanation: Amber containers protect drugs from light degradation.
5. The term “expiry date” refers to the:
   A. Date of manufacture
   B. Last recommended usage date ✅
   C. Date of packaging
   D. Storage temperature
   Explanation: Expiry date indicates the last day the drug is expected to remain effective.
6. A drug labeled “store in a cool place” should be stored at:
   A. 8°C–15°C ✅
   B. 2°C–8°C
   C. 15°C–30°C
   D. Below 0°C
   Explanation: “Cool place” refers to a temperature range of 8°C to 15°C.
7. Which container best protects against moisture?
   A. Paper bag
   B. Amber glass bottle
   C. Plastic bottle
   D. Blister pack with desiccant ✅
   Explanation: Desiccants help control humidity, especially in blister packs.
8. Drugs sensitive to hydrolysis should be protected from:
   A. Light
   B. Moisture ✅
   C. Heat
   D. Oxygen
   Explanation: Hydrolysis occurs in the presence of water; hence, moisture should be avoided.
9. The term “cold chain” refers to:
   A. Pharmaceutical logistics for vaccines ✅
   B. Drug pricing policy
   C. Inventory of expired products
   D. Packaging materials
   Explanation: Cold chain ensures temperature-controlled storage and transport.
10. Freeze-sensitive drugs should never be stored at:
    A. 15°C
    B. 8°C
    C. -5°C ✅
    D. 25°C
    Explanation: Freezing can damage sensitive biological products.
11. Photodegradation of drugs occurs due to exposure to:
    A. Moisture
    B. Temperature
    C. Light ✅
    D. Oxygen
    Explanation: Light exposure can break down sensitive drug molecules.
12. Which of the following can lead to oxidation of drugs?
    A. Oxygen ✅
    B. Cold
    C. Light
    D. Dry air
    Explanation: Oxidation involves reaction with atmospheric oxygen.
13. Which parameter is commonly monitored in pharmaceutical storage?
    A. Pressure
    B. Salinity
    C. Temperature ✅
    D. Turbidity
    Explanation: Temperature is critical to maintaining drug stability.
14. Which of the following storage conditions is ideal for insulin?
    A. -20°C
    B. 15°C–25°C
    C. 2°C–8°C ✅
    D. 30°C
    Explanation: Insulin requires refrigeration between 2°C and 8°C.
15. Which of the following drugs requires protection from light?
    A. Paracetamol
    B. Furosemide ✅
    C. Ranitidine
    D. Aspirin
    Explanation: Furosemide degrades when exposed to light.
16. Which of the following is a dry storage condition?
    A. 25°C with 75% RH
    B. 15°C with 80% RH
    C. 25°C with desiccants ✅
    D. 8°C in a refrigerator
    Explanation: Desiccants reduce humidity and help maintain dryness.
17. Humidity is measured in terms of:
    A. pH
    B. Temperature
    C. Relative humidity (RH) ✅
    D. Pressure
    Explanation: RH indicates the moisture content in the air.
18. If a label says “store below 25°C,” what does it imply?
    A. The drug should be frozen
    B. Store in refrigerator
    C. Room temperature storage ✅
    D. Use within 10 days
    Explanation: “Below 25°C” refers to controlled room temperature.
19. Stability testing helps in determining:
    A. Drug cost
    B. Storage location
    C. Shelf life ✅
    D. Manufacturer
    Explanation: Stability testing determines how long a drug remains effective.
20. What type of drug is most sensitive to temperature variations?
    A. Antacids
    B. Hormonal products ✅
    C. Antibiotics
    D. NSAIDs
    Explanation: Hormones and biologics are highly temperature-sensitive.

🟡 Moderate (21–40)

21. Shelf life is defined as the period during which the drug:
    A. Changes color
    B. Remains potent and safe ✅
    C. Is being sold
    D. Can be manufactured
    Explanation: Shelf life refers to the duration a drug retains its quality.
22. Desiccants are used to control:
    A. Light
    B. Temperature
    C. Moisture ✅
    D. Air circulation
    Explanation: Desiccants absorb moisture and prevent degradation.
23. A stability-indicating assay method:
    A. Measures taste
    B. Detects only color change
    C. Distinguishes drug from its degradation products ✅
    D. Evaluates packaging
    Explanation: It ensures drug and its degradation products are identified separately.
24. Hydrolysis is a major degradation pathway in:
    A. Dry powders
    B. Aqueous solutions ✅
    C. Tablets
    D. Gels
    Explanation: Hydrolysis requires water; hence, solutions are more prone.
25. Which class of drugs is highly photosensitive?
    A. Penicillins
    B. Tetracyclines ✅
    C. NSAIDs
    D. Diuretics
    Explanation: Tetracyclines degrade under light exposure.
26. The function of a cold chain monitor is to:
    A. Adjust humidity
    B. Record light exposure
    C. Track temperature deviations ✅
    D. Extend expiry
    Explanation: It tracks temperature throughout the cold chain.
27. Stability studies under accelerated conditions involve:
    A. Reduced temperature
    B. Increased light only
    C. Elevated temperature and humidity ✅
    D. No changes
    Explanation: Accelerated studies use stress conditions for faster analysis.
28. Which dosage form is most stable?
    A. Syrups
    B. Tablets ✅
    C. Suspensions
    D. Creams
    Explanation: Tablets are dry and hence more stable than liquid or semi-solid forms.
29. What is the purpose of packaging drugs in blister packs?
    A. Branding
    B. Dose marking
    C. Protection from environmental factors ✅
    D. Easy stacking
    Explanation: Blister packs shield drugs from moisture and light.
30. A drug’s chemical stability refers to its ability to:
    A. Dissolve rapidly
    B. Resist degradation over time ✅
    C. Produce fewer side effects
    D. Change pH
    Explanation: Chemical stability means drug resists chemical changes.
31. Which of these is a physical sign of instability?
    A. Change in taste
    B. Formation of precipitate ✅
    C. pH reduction
    D. Increase in potency
    Explanation: Precipitation is a visible sign of instability.
32. A drug in suspension form must be:
    A. Shaken before use ✅
    B. Frozen
    C. Protected from cold
    D. Dissolved
    Explanation: Suspensions are heterogeneous and need agitation.
33. Which environmental condition accelerates oxidation reactions?
    A. Cold
    B. Light
    C. Oxygen and heat ✅
    D. Acidity
    Explanation: Oxidation increases in the presence of oxygen and heat.
34. Modified-release drugs should be stored:
    A. In light
    B. In freezer
    C. As per label recommendations ✅
    D. At high humidity
    Explanation: Their coating may be sensitive to environmental changes.
35. Which of these is used to evaluate microbiological stability?
    A. HPLC
    B. pH meter
    C. Microbial limit test ✅
    D. Refractometer
    Explanation: It checks microbial contamination during shelf life.
36. Which of the following is a regulatory guideline for drug stability?
    A. GDP
    B. ICH Q1A ✅
    C. USP 797
    D. GCP
    Explanation: ICH Q1A outlines stability testing guidelines.
37. Drug discoloration is most often due to:
    A. Improved potency
    B. Microbial growth
    C. Degradation ✅
    D. Poor mixing
    Explanation: Color change is a sign of chemical degradation.
38. Storage at high humidity may lead to:
    A. Enhanced potency
    B. Caking of tablets ✅
    C. Better dissolution
    D. Freezing
    Explanation: Moisture causes tablets to clump or degrade.
39. Which of the following containers offers best light protection?
    A. Clear glass
    B. Green plastic
    C. Amber glass ✅
    D. Transparent pouch
    Explanation: Amber glass filters out UV and visible light.
40. Which dosage form is most sensitive to freezing?
    A. Tablet
    B. Ointment
    C. Emulsion ✅
    D. Capsule
    Explanation: Freezing disrupts emulsions and causes separation.

🔴 Hard (41–50)

41. The stability of a reconstituted antibiotic suspension is:
    A. Infinite
    B. Until taste changes
    C. Time-limited (as per label) ✅
    D. Same as powder form
    Explanation: Reconstituted forms degrade faster.
42. A drug exhibiting polymorphism may show changes in:
    A. Smell
    B. Solubility and stability ✅
    C. Potency
    D. pH
    Explanation: Different crystal forms can vary in solubility and stability.
43. Freezing vaccines can cause:
    A. Increase in potency
    B. Protein denaturation ✅
    C. Better stability
    D. Longer shelf life
    Explanation: Freezing can destroy protein-based vaccines.
44. Which factor affects the kinetic rate of drug degradation?
    A. Drug name
    B. Manufacturer
    C. Temperature ✅
    D. Shape
    Explanation: Higher temperatures increase reaction rates.
45. An isotonic solution’s stability may be affected by:
    A. pH change ✅
    B. Taste
    C. Weight
    D. Size
    Explanation: pH shifts can cause drug degradation or precipitation.
46. Photostability testing involves exposure to:
    A. High humidity
    B. Artificial light sources ✅
    C. Oxygen
    D. Ethanol
    Explanation: It checks drug stability under light exposure.
47. Hygroscopic drugs should be stored in:
    A. Paper wrappers
    B. Plastic jars
    C. Airtight containers with desiccants ✅
    D. Open boxes
    Explanation: They absorb moisture and need dry storage.
48. A stability chamber is used to:
    A. Package tablets
    B. Store documentation
    C. Simulate environmental stress conditions ✅
    D. Maintain sterility
    Explanation: Stability chambers test how drugs behave under various conditions.
49. Microbial contamination is most likely in:
    A. Tablets
    B. Capsules
    C. Syrups ✅
    D. Suppositories
    Explanation: Aqueous syrups are prone to microbial growth.
50. ICH guidelines recommend long-term stability testing at:
    A. 30°C/75% RH
    B. 25°C/60% RH ✅
    C. 10°C/40% RH
    D. 45°C/90% RH
    Explanation: 25°C/60% RH is the standard long-term condition.