Stability testing protocols and shelf-life assessment for herbal medicines MCQs With Answer

Introduction: Stability testing and shelf-life assessment are essential for ensuring the safety, efficacy, and quality of herbal medicines throughout their marketed lifetime. This set of MCQs is designed for M.Pharm students studying Industrial Pharmacognostical Technology (MPG 104T) and focuses on practical and theoretical aspects of protocol design, forced degradation studies, analytical method validation, regulatory guidance, packaging influences, and statistical approaches for shelf-life estimation specific to herbal products. The questions emphasize complexities unique to botanicals—batch variability, marker compound selection, microbial stability, and volatile constituents—to prepare students for real-world stability protocols and regulatory submissions.

Q1. Which ICH guideline is primarily referred to for conducting stability studies for finished herbal medicinal products?

• ICH Q1A(R2) Stability Testing of New Drug Substances and Products
• ICH Q2(R1) Validation of Analytical Procedures
• ICH Q3A Impurities in New Drug Substances
• ICH Q5 Stability of Biotechnological Products

Correct Answer: ICH Q1A(R2) Stability Testing of New Drug Substances and Products

Q2. For a herbal dry powder formulation, which accelerated stability condition is commonly used to obtain predictive data?

• 40°C ± 2°C / 75% ± 5% RH
• 25°C ± 2°C / 60% ± 5% RH
• 4°C ± 2°C / ambient RH
• 60°C ± 2°C / 90% ± 5% RH

Correct Answer: 40°C ± 2°C / 75% ± 5% RH

Q3. Which analytical approach is most appropriate to monitor the chemical stability of a multi-component herbal extract?

• Single marker assay only
• Stability-indicating HPLC profiling with multiple marker compounds
• Only organoleptic evaluation
• Thin-layer chromatography without quantitation

Correct Answer: Stability-indicating HPLC profiling with multiple marker compounds

Q4. What is the primary purpose of forced degradation studies for herbal medicines?

• To establish therapeutic dose ranges
• To identify degradation pathways and develop stability-indicating methods
• To determine microbial contamination limits
• To assess consumer acceptability

Correct Answer: To identify degradation pathways and develop stability-indicating methods

Q5. When selecting marker compounds for stability testing of a polyherbal formulation, the best practice is to:

• Choose the most abundant single constituent only
• Select multiple markers representing different chemical classes and therapeutically relevant constituents
• Ignore markers and test only for moisture content
• Use only volatile oil content for all formulations

Correct Answer: Select multiple markers representing different chemical classes and therapeutically relevant constituents

Q6. Which of the following is a correct reason why botanical raw material variability must be considered in stability protocols?

• It affects packaging color choice
• Variability can influence degradation rates and shelf-life predictions due to differing initial constituent profiles
• It determines manufacturing shift schedules
• It only impacts taste, not chemical stability

Correct Answer: Variability can influence degradation rates and shelf-life predictions due to differing initial constituent profiles

Q7. In shelf-life estimation using the Arrhenius approach, which assumption is fundamental?

• Degradation rate is independent of temperature
• Degradation follows a temperature-dependent rate with a defined activation energy
• Humidity has no effect on chemical stability
• All degradation is photochemical only

Correct Answer: Degradation follows a temperature-dependent rate with a defined activation energy

Q8. For herbal tinctures containing ethanol, which stability concern is most critical compared to dry extracts?

• Moisture sorption only
• Volatilization of ethanol and loss of volatiles, leading to potency and preservation changes
• Increased photostability
• Complete resistance to microbial growth

Correct Answer: Volatilization of ethanol and loss of volatiles, leading to potency and preservation changes

Q9. Which packaging attribute is most important to control oxidative degradation of susceptible herbal actives?

• Oxygen permeability of the container-closure system
• Container color only for aesthetics
• Size of the outer carton text
• Weight of the primary container material

Correct Answer: Oxygen permeability of the container-closure system

Q10. Microbial stability assessment in herbal products should include:

• Only total aerobic count without specification
• Total aerobic microbial count, specified objectionable organisms, and preservative efficacy where relevant
• Only fungal counts for all products
• No testing if product contains alcohol

Correct Answer: Total aerobic microbial count, specified objectionable organisms, and preservative efficacy where relevant

Q11. Which statistical method is commonly used to determine shelf-life from long-term stability data?

• Kaplan–Meier survival analysis
• Linear regression of potency versus time with 95% confidence interval to estimate time to specification limit
• Principal component analysis only
• Chi-square test comparing batches

Correct Answer: Linear regression of potency versus time with 95% confidence interval to estimate time to specification limit

Q12. For herbal products with volatile oil marker analytes, which stress condition should be prioritized during forced degradation?

• High humidity only
• Thermal stress under open conditions and headspace analysis for volatilization
• Only alkaline hydrolysis
• Freeze–thaw cycles exclusively

Correct Answer: Thermal stress under open conditions and headspace analysis for volatilization

Q13. What is the recommended approach when a stability-indicating assay for a complex herbal extract cannot fully separate all degradation products?

• Proceed without improvement if major marker is stable
• Use orthogonal analytical techniques (e.g., LC-MS, GC-MS, NMR) to characterize degradants and confirm assay specificity
• Reduce study duration to avoid degradant formation
• Ignore degradants since herbal matrices are complex

Correct Answer: Use orthogonal analytical techniques (e.g., LC-MS, GC-MS, NMR) to characterize degradants and confirm assay specificity

Q14. In stability protocols for herbal products, a ‘retest period’ is preferred over an ‘expiry date’ when:

• The finished product is expected to gain potency over time
• The active botanical material is a raw herbal drug subject to variability and restandardization before formulation
• The product is a sterile injectable
• Regulatory authorities prohibit retest periods

Correct Answer: The active botanical material is a raw herbal drug subject to variability and restandardization before formulation

Q15. Photostability testing for herbal extracts aims to determine:

• Only changes in color irrespective of potency
• Sensitivity of active constituents to UV/visible light and need for light-protective packaging
• Microbial growth under light exposure
• Melting point changes due to light

Correct Answer: Sensitivity of active constituents to UV/visible light and need for light-protective packaging

Q16. Which criterion is most appropriate for defining failure in stability studies of an herbal drug product?

• Any perceptible color change
• Loss of assay beyond predefined specification, increase in harmful degradants, or failure of microbial/preservative specifications
• Minor change in odor irrespective of potency
• Packaging dents

Correct Answer: Loss of assay beyond predefined specification, increase in harmful degradants, or failure of microbial/preservative specifications

Q17. During real-time stability testing of a herbal capsule, which measured parameter is least informative for chemical stability?

• Assay of marker compounds by validated HPLC
• Content uniformity of capsules
• Moisture content if hygroscopic excipients are present
• Headspace oxygen in sealed blister packs

Correct Answer: Content uniformity of capsules

Q18. When extrapolating shelf-life from accelerated data for a thermally labile herbal constituent, the major risk is:

• Underestimation of manufacturing cost
• Incorrect activation energy assumption leading to inaccurate shelf-life prediction
• Overestimation of microbial stability
• Ignoring packaging aesthetics

Correct Answer: Incorrect activation energy assumption leading to inaccurate shelf-life prediction

Q19. Which preservative efficacy test consideration is especially important for herbal aqueous formulations?

• Testing only for preservative identity
• Challenge testing with representative microbes and using realistic product matrix because plant constituents can interact with preservatives
• Using preservatives without any compatibility checks
• Preservative tests are unnecessary if product is pasteurized

Correct Answer: Challenge testing with representative microbes and using realistic product matrix because plant constituents can interact with preservatives

Q20. For a herbal formulation containing an unstable glycoside prone to hydrolysis, which packaging/storage recommendation is most appropriate to enhance shelf-life?

• Store at 40°C in open containers
• Use airtight, low-moisture packaging and recommend cool storage to minimize hydrolytic degradation
• Expose to light to increase drying
• Package in highly hygroscopic material to absorb water

Correct Answer: Use airtight, low-moisture packaging and recommend cool storage to minimize hydrolytic degradation

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