Interactions of environmental factors on nutraceutical stability MCQs With Answer

Interactions of environmental factors on nutraceutical stability MCQs With Answer

In this concise overview, B.Pharm students will learn how environmental factors interact to influence nutraceutical stability. Temperature, humidity, light exposure, oxygen, pH, and microbial load can accelerate chemical degradation, oxidation, hydrolysis, and loss of bioactivity in vitamins, polyphenols, omega‑3 oils, and probiotics. Formulation variables and excipients, packaging materials, and storage conditions modulate these effects, while antioxidants, chelating agents, and controlled‑release systems can improve shelf life. Understanding mechanisms of degradation, stability testing protocols, and accelerated stability studies is essential for product development and quality assurance. This focused primer emphasizes practical concepts, analytical considerations, and formulation strategies for preserving nutraceutical potency. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which environmental factor most directly accelerates hydrolytic degradation of water‑sensitive nutraceuticals?

  • Light exposure
  • High humidity
  • Oxygen
  • Low temperature

Correct Answer: High humidity

Q2. Which packaging strategy best reduces oxidative degradation of omega‑3 rich nutraceutical oils?

  • Permeable plastic bottles without headspace control
  • Opaque glass with nitrogen headspace and oxygen scavenger
  • Uncoated paperboard with perforations
  • Clear PET bottles with no barrier coating

Correct Answer: Opaque glass with nitrogen headspace and oxygen scavenger

Q3. Photodegradation of a vitamin is primarily caused by which mechanism?

  • Hydrolysis catalyzed by water
  • Absorption of photons leading to excited states and bond cleavage
  • pH‑dependent ionic rearrangement
  • Thermal denaturation only at high temperatures

Correct Answer: Absorption of photons leading to excited states and bond cleavage

Q4. Which factor is most important when designing accelerated stability studies for nutraceuticals using the Arrhenius approach?

  • Assuming non‑first order kinetics without verification
  • Selecting temperatures that do not introduce new degradation pathways
  • Using room temperature only
  • Ignoring humidity because it only affects solids

Correct Answer: Selecting temperatures that do not introduce new degradation pathways

Q5. A Q10 value of 2 for a degradation reaction implies what?

  • Rate doubles for every 10°C increase in temperature
  • Rate decreases by half for every 10°C increase
  • Rate is independent of temperature
  • Reaction follows zero‑order kinetics

Correct Answer: Rate doubles for every 10°C increase in temperature

Q6. Which excipient property helps protect hygroscopic vitamin powders from moisture uptake?

  • High hygroscopicity
  • Low glass transition temperature
  • Use of desiccant packets and moisture‑barrier coating
  • Inclusion of metal ions that catalyze oxidation

Correct Answer: Use of desiccant packets and moisture‑barrier coating

Q7. Metal ion contaminants in nutraceutical formulations often promote degradation by what route?

  • Acting as antioxidants to stabilize compounds
  • Catalyzing free radical formation and oxidative reactions
  • Reducing water activity to zero
  • Blocking light absorption entirely

Correct Answer: Catalyzing free radical formation and oxidative reactions

Q8. Which analytical parameter is essential for a stability‑indicating assay?

  • Ability to resolve parent compound from its degradation products
  • Only measuring pH changes
  • Detecting excipient impurities exclusively
  • Measuring color change without specificity

Correct Answer: Ability to resolve parent compound from its degradation products

Q9. For probiotics in nutraceuticals, the most critical environmental control is:

  • Minimizing oxygen only
  • Controlling moisture and temperature to maintain viability
  • Protecting from light exclusively
  • Adding strong oxidizers to preserve cells

Correct Answer: Controlling moisture and temperature to maintain viability

Q10. Which statement about pH and vitamin C (ascorbic acid) stability is correct?

  • Vitamin C is most stable at strongly alkaline pH
  • Ascorbic acid is more stable at acidic pH and susceptible to oxidative degradation at neutral/alkaline pH
  • pH has no effect on ascorbic acid stability
  • Vitamin C is stabilized by metal ions at any pH

Correct Answer: Ascorbic acid is more stable at acidic pH and susceptible to oxidative degradation at neutral/alkaline pH

Q11. Glass transition temperature (Tg) is important for amorphous nutraceutical powders because:

  • Below Tg, molecular mobility decreases and chemical degradation slows
  • Tg determines color stability only
  • Above Tg, materials become completely inert
  • Tg is unrelated to moisture sorption

Correct Answer: Below Tg, molecular mobility decreases and chemical degradation slows

Q12. Which packaging material best protects photosensitive nutraceuticals from UV‑induced degradation?

  • Clear glass
  • Amber glass or UV‑blocking polymer
  • Uncoated cellulose paper
  • Thin clear polyethylene film

Correct Answer: Amber glass or UV‑blocking polymer

Q13. Which preventive measure helps minimize metal‑catalyzed oxidative degradation?

  • Adding trace transition metals intentionally
  • Using chelating agents such as EDTA
  • Increasing water activity
  • Storing in direct sunlight

Correct Answer: Using chelating agents such as EDTA

Q14. A zero‑order degradation reaction implies:

  • Rate depends on concentration squared
  • Rate is constant and independent of concentration
  • Rate doubles with concentration
  • Rate follows first‑order kinetics exactly

Correct Answer: Rate is constant and independent of concentration

Q15. Which environmental control is most effective for reducing Maillard browning in protein–sugar containing nutraceuticals?

  • Increasing storage temperature
  • Lowering water activity to inhibit reaction
  • Raising pH to alkaline range
  • Exposing to light regularly

Correct Answer: Lowering water activity to inhibit reaction

Q16. Which antioxidant is commonly used to protect lipid‑based nutraceuticals from oxidation?

  • Sodium chloride
  • Tocopherols (vitamin E)
  • Iron sulfate
  • Hydrogen peroxide

Correct Answer: Tocopherols (vitamin E)

Q17. Modified atmosphere packaging (MAP) improves stability primarily by:

  • Increasing headspace oxygen concentration
  • Replacing oxygen with inert gases like nitrogen or CO2
  • Increasing humidity around the product
  • Removing desiccants from the package

Correct Answer: Replacing oxygen with inert gases like nitrogen or CO2

Q18. Which kinetic order is most commonly assumed for simple first‑order nutrient degradation?

  • Zero‑order
  • First‑order where ln(concentration) vs time is linear
  • Second‑order with inverse concentration dependence
  • Fractional order only

Correct Answer: First‑order where ln(concentration) vs time is linear

Q19. Which factor increases the risk of lipid peroxidation in encapsulated omega‑3 formulations?

  • High oxidative stability of the core oil
  • Presence of pro‑oxidant metals and high oxygen permeability in shell
  • Use of high‑barrier polymer shells
  • Inclusion of natural antioxidants

Correct Answer: Presence of pro‑oxidant metals and high oxygen permeability in shell

Q20. Hygroscopic excipients can impact stability by:

  • Lowering local water activity and preventing hydrolysis
  • Absorbing moisture and increasing localized water activity leading to degradation
  • Completely preventing oxygen diffusion always
  • Making formulations immune to temperature effects

Correct Answer: Absorbing moisture and increasing localized water activity leading to degradation

Q21. Which stress condition is commonly used in forced‑degradation studies to identify likely degradation products?

  • Isoelectric focusing only
  • Heat, light, acid/base hydrolysis, and oxidation
  • Storage exclusively at −80°C
  • Exposure only to inert gases

Correct Answer: Heat, light, acid/base hydrolysis, and oxidation

Q22. Water activity (aw) is crucial because it:

  • Directly equals moisture content by weight
  • Reflects the availability of water for chemical and microbial reactions
  • Is irrelevant for powdered nutraceuticals
  • Always increases stability when higher

Correct Answer: Reflects the availability of water for chemical and microbial reactions

Q23. Which storage condition would most likely preserve a carotenoid‑rich nutraceutical?

  • High temperature, high humidity, and light exposure
  • Cool, dark, and low oxygen environment with antioxidant protection
  • Strong alkaline solution exposure
  • Frequent freeze–thaw cycles

Correct Answer: Cool, dark, and low oxygen environment with antioxidant protection

Q24. Which excipient function can protect sensitive actives via physical separation in a solid dosage form?

  • Hygroscopic fillers that draw moisture in
  • Use of protective carriers or encapsulation matrices
  • Addition of catalytic metal salts
  • Permeable coatings that allow air ingress

Correct Answer: Use of protective carriers or encapsulation matrices

Q25. Which statement about humidity chambers in stability testing is true?

  • Relative humidity has no effect on solid dosage forms
  • Specified RH and temperature combinations simulate real storage stresses and study moisture‑related degradation
  • Only dry conditions are ever used for shelf‑life testing
  • Humidity chambers are used exclusively for microbial testing

Correct Answer: Specified RH and temperature combinations simulate real storage stresses and study moisture‑related degradation

Q26. Which packaging additive actively removes oxygen from the headspace to protect oxidizable nutraceuticals?

  • Desiccant sachet
  • Oxygen scavenger sachet
  • UV stabilizer
  • Fragrance sachet

Correct Answer: Oxygen scavenger sachet

Q27. Which mechanism is least likely to be influenced by light exposure?

  • Photooxidation of polyunsaturated oils
  • Photolytic cleavage of sensitive bonds in vitamins
  • Hydrolytic cleavage of ester bonds in anhydrous solid matrix
  • Photosensitized generation of reactive oxygen species

Correct Answer: Hydrolytic cleavage of ester bonds in anhydrous solid matrix

Q28. A stability study showing a linear decrease in potency vs time suggests which kinetic model?

  • First‑order kinetics
  • Zero‑order kinetics
  • Second‑order kinetics
  • Non‑kinetic random loss

Correct Answer: Zero‑order kinetics

Q29. Which formulation strategy can improve the thermal stability of heat‑labile nutraceuticals?

  • Spray‑drying into a protective amorphous matrix with high Tg excipients
  • Exposing the product to repeated heating cycles
  • Removing all antioxidants
  • Formulating with catalytic metal ions

Correct Answer: Spray‑drying into a protective amorphous matrix with high Tg excipients

Q30. According to ICH guidelines, which condition is typically included in long‑term stability testing for products stored at controlled room temperature?

  • 40°C and 75% RH only
  • 25°C and 60% RH (or regionally appropriate conditions) for long‑term testing
  • −20°C storage only
  • Continuous light exposure without temperature control

Correct Answer: 25°C and 60% RH (or regionally appropriate conditions) for long‑term testing

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