Stability aspects of packaging materials MCQs With Answer

Stability aspects of packaging materials MCQs With Answer
Introduction: Packaging materials profoundly influence drug stability by controlling exposure to moisture, oxygen, light and leachables. For B. Pharm students, understanding barrier properties, water vapor and oxygen transmission rates, sorption/desorption, extractables & leachables, container-closure integrity, and photostability is essential for formulation protection and shelf-life prediction. Material selection (glass, plastics, elastomers, laminates), sterilization effects, plasticizers, glass transition (Tg), and regulatory expectations (ICH stability guidance, E&L assessments) are key topics. This set of questions emphasizes practical assessment, testing methods and failure modes to deepen your competence in pharmaceutical packaging stability. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which property of a packaging material primarily determines its resistance to water vapor permeation?

• Oxygen transmission rate
• Water vapor transmission rate
• Light transmission
• Surface energy

Correct Answer: Water vapor transmission rate

Q2. Which material is most suitable for parenteral containers due to chemical inertness and low leachables?

• Polyvinyl chloride (PVC)
• High-density polyethylene (HDPE)
• Borosilicate glass
• Polystyrene (PS)

Correct Answer: Borosilicate glass

Q3. What does OTR stand for in packaging stability evaluation?

• Overall thermal resilience
• Oxygen transmission rate
• Oxidative tolerance ratio
• Outer tensile resistance

Correct Answer: Oxygen transmission rate

Q4. Which test is commonly used to assess container-closure integrity for sterile products?

• Water vapor sorption
• Dye ingress
• UV-visible spectroscopy
• pH titration

Correct Answer: Dye ingress

Q5. Which packaging failure is directly related to plasticizer migration from PVC into the drug product?

• Glass delamination
• Leaching of phthalates
• Oxygen scavenging
• Photodegradation

Correct Answer: Leaching of phthalates

Q6. Which polymer has the best oxygen barrier among common plastics used for oral solid dose packaging?

• Polyethylene terephthalate (PET)
• Low-density polyethylene (LDPE)
• Polypropylene (PP)
• Polyvinyl chloride (PVC)

Correct Answer: Polyethylene terephthalate (PET)

Q7. What is the primary function of a desiccant in pharmaceutical packaging?

• Scavenge oxygen
• Absorb moisture
• Provide mechanical cushioning
• Block light transmission

Correct Answer: Absorb moisture

Q8. Which phenomenon describes the uptake of drug from the formulation onto the polymeric container surface?

• Leaching
• Sorption
• Photolysis
• Delamination

Correct Answer: Sorption

Q9. For accelerated stability studies, which ICH-recommended condition is commonly used for long-term accelerated testing of drug products in tropical climates?

• 25°C/60% RH
• 30°C/65% RH
• 40°C/75% RH
• 50°C/20% RH

Correct Answer: 40°C/75% RH

Q10. Which sterilization method can cause chain scission and embrittlement in some polymers due to high-energy radiation?

• Ethylene oxide (EtO) sterilization
• Autoclaving (moist heat)
• Gamma irradiation
• Dry heat sterilization

Correct Answer: Gamma irradiation

Q11. Which packaging attribute is most relevant to protect photosensitive APIs?

• Low oxygen permeability
• High mechanical strength
• Light blocking (opacity or UV filter)
• High moisture sorption

Correct Answer: Light blocking (opacity or UV filter)

Q12. Glass transition temperature (Tg) of a polymer affects which stability aspect most directly?

• Photostability
• Permeability only to oxygen
• Molecular mobility and diffusion rates
• Glass delamination

Correct Answer: Molecular mobility and diffusion rates

Q13. Which term describes chemical species released from packaging during exaggerated extraction conditions used to predict potential migrants?

• Leachables
• Degradants
• Extractables
• Impurities

Correct Answer: Extractables

Q14. Which analytical approach is typically used to identify unknown extractables from polymeric packaging?

• Gas chromatography–mass spectrometry (GC-MS)
• Karl Fischer titration
• pH meter measurement
• UV spectrophotometry only

Correct Answer: Gas chromatography–mass spectrometry (GC-MS)

Q15. What is the most probable effect of high humidity on hygroscopic drug products in permeable packaging?

• Decreased dissolution rate due to moisture uptake
• Increased oxygen scavenging
• Sterilization of the product
• Reduced photodegradation

Correct Answer: Decreased dissolution rate due to moisture uptake

Q16. Which layer in a laminated blister provides the primary moisture barrier when aluminium foil is not used?

• PVC (polyvinyl chloride)
• Paperboard
• PVDC (polyvinylidene chloride) or EVOH (ethylene vinyl alcohol)
• Polystyrene

Correct Answer: PVDC (polyvinylidene chloride) or EVOH (ethylene vinyl alcohol)

Q17. Which packaging test evaluates the rate at which water vapor passes through the material over time?

• Oxygen ingress test
• Water vapor transmission rate (WVTR) test
• Light transmission test
• Headspace analysis

Correct Answer: Water vapor transmission rate (WVTR) test

Q18. Glass delamination refers to which of the following issues?

• Surface flaking or formation of glass particulates into the product
• Migration of plasticizers into the drug
• Loss of seal in blister packs
• Oxidation of API due to oxygen ingress

Correct Answer: Surface flaking or formation of glass particulates into the product

Q19. Which of the following is an active packaging component used to reduce headspace oxygen?

• Desiccant sachet
• Oxygen scavenger sachet
• UV absorber film
• Foam cushion

Correct Answer: Oxygen scavenger sachet

Q20. Which factor increases the rate of migration of low molecular weight species from packaging into a drug solution?

• Lower storage temperature
• Higher molecular weight of migrant
• Increased contact time and temperature
• Reduced solvent polarity

Correct Answer: Increased contact time and temperature

Q21. What is the main regulatory concern addressed by extractables and leachables (E&L) testing?

• Mechanical strength of packaging
• Toxicological risk from chemical migrants
• Pharmaceutical pricing
• Packaging recyclability

Correct Answer: Toxicological risk from chemical migrants

Q22. Which stopper material is commonly used for lyophilized parenterals because of good chemical resistance and low extractables?

• Natural rubber
• Bromobutyl or chlorobutyl elastomer
• Soft PVC
• Polystyrene foam

Correct Answer: Bromobutyl or chlorobutyl elastomer

Q23. Which packaging-related process can catalyze API degradation due to residual peroxides?

• Use of antioxidant sachets
• Polymer oxidation during gamma sterilization
• Sealing with aluminium foil
• Adding desiccant packets

Correct Answer: Polymer oxidation during gamma sterilization

Q24. Which parameter is most useful to quantify the barrier performance of an aluminium foil laminate against gases?

• Tensile strength
• Oxygen transmission rate (OTR)
• Glass transition temperature
• Contact angle

Correct Answer: Oxygen transmission rate (OTR)

Q25. What is the likely consequence if a polymer packaging material has Tg below storage temperature?

• Material will be glassy and rigid
• Increased molecular mobility leading to higher diffusion rates
• Complete impermeability to gases
• Enhanced UV protection

Correct Answer: Increased molecular mobility leading to higher diffusion rates

Q26. Which analytical technique is preferred for quantifying leachables in aqueous drug products at trace levels?

• Thermogravimetric analysis (TGA)
• Liquid chromatography–mass spectrometry (LC-MS)
• Simple pH measurement
• Melting point determination

Correct Answer: Liquid chromatography–mass spectrometry (LC-MS)

Q27. Modified atmosphere packaging (MAP) for solid oral dosage forms typically replaces headspace with which gas to improve stability?

• Carbon dioxide (CO2)
• Nitrogen (N2)
• Oxygen (O2)
• Helium (He)

Correct Answer: Nitrogen (N2)

Q28. Which packaging choice is most appropriate to prevent adsorption of a hydrophobic peptide to container walls?

• Use of glass with silicone coating or low-binding polymer
• Use of PVC with DEHP plasticizer
• Polystyrene vials without coating
• Cardboard inner liners only

Correct Answer: Use of glass with silicone coating or low-binding polymer

Q29. What is the main role of an aluminum foil lidding in blister packaging for hygroscopic tablets?

• Provide mechanical cushioning
• Act as a high moisture and oxygen barrier
• Enhance tablet dissolution
• Improve product aesthetics only

Correct Answer: Act as a high moisture and oxygen barrier

Q30. Which practice helps minimize extractables and leachables risk during stability studies?

• Selecting materials with known E&L profiles and performing controlled extraction studies
• Avoiding any analytical testing
• Using the cheapest available packaging
• Storing products only at extremely high temperatures

Correct Answer: Selecting materials with known E&L profiles and performing controlled extraction studies

G S Sachin

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.

Mail- Sachin@pharmacyfreak.com