Standardization, shelf-life and stability studies of ISM formulations MCQs With Answer

Introduction:

This quiz collection focuses on standardization, shelf-life and stability studies of Indian Systems of Medicine (ISM) formulations, tailored for M. Pharm students. It covers core concepts such as physicochemical and organoleptic standardization, chromatographic and DNA-based identification, microbial and heavy‑metal limits, and stability study design including real‑time, accelerated and forced‑degradation approaches. Practical topics include stability‑indicating methods, packaging effects, kinetics and shelf‑life estimation methods (Arrhenius and Q10), and regulatory expectations relevant to herbal/ISM products. These MCQs aim to deepen understanding for laboratory practice, formulation development, and regulatory documentation preparation in the context of ISM standardization and stability evaluation.

Q1. What is the primary objective of standardization of an ISM formulation?

• To make the product more palatable
• To ensure consistent identity, quality, purity and strength of batches
• To reduce production cost
• To increase the shelf life beyond regulatory limits

Correct Answer: To ensure consistent identity, quality, purity and strength of batches

Q2. Which of the following tests is NOT typically part of physicochemical standardization of a powdered herbal ISM drug?

• Loss on drying / moisture content
• Total ash and acid-insoluble ash
• HPTLC fingerprint profile
• Genotoxicity in vivo assay

Correct Answer: Genotoxicity in vivo assay

Q3. HPTLC fingerprinting for ISM formulations is primarily used to:

• Replace all other quality tests
• Provide a reproducible chemical profile for identity and batch-to-batch comparison
• Determine the exact therapeutic dose
• Measure microbial contamination

Correct Answer: Provide a reproducible chemical profile for identity and batch-to-batch comparison

Q4. Which set of contaminants is routinely tested as part of safety limits for ISM formulations?

• Pesticide residues only
• Heavy metals (lead, arsenic, mercury, cadmium) and microbial limits
• Only aflatoxins
• UV absorbance at 254 nm

Correct Answer: Heavy metals (lead, arsenic, mercury, cadmium) and microbial limits

Q5. Which parameter is most critical when conducting stability studies of hygroscopic ISM powders?

• Light exposure
• Relative humidity control and moisture uptake
• Sound insulation of the stability room
• Magnetic field exposure

Correct Answer: Relative humidity control and moisture uptake

Q6. According to common stability study design, which two study conditions are basic for determining shelf-life?

• Refrigerated and frozen
• Real-time (long-term) and accelerated
• Photostability and radon exposure
• Ultrasonic stability and centrifugation stability

Correct Answer: Real-time (long-term) and accelerated

Q7. What are the typical ICH accelerated stability conditions often adopted for herbal/ISM stability studies?

• 25 ± 2°C / 40 ± 5% RH
• 40 ± 2°C / 75 ± 5% RH
• 5 ± 3°C / ambient RH
• 60 ± 5°C / 20 ± 5% RH

Correct Answer: 40 ± 2°C / 75 ± 5% RH

Q8. Forced degradation studies for an ISM formulation are performed mainly to:

• Improve taste of the formulation
• Demonstrate that analytical methods are stability‑indicating and to predict degradation pathways
• Increase the active marker content artificially
• Reduce production time

Correct Answer: Demonstrate that analytical methods are stability‑indicating and to predict degradation pathways

Q9. The Arrhenius equation is applied in stability testing to:

• Calculate the moisture content of a sample
• Predict reaction rate changes with temperature and extrapolate shelf‑life from accelerated data
• Measure pH stability
• Determine particle size distribution

Correct Answer: Predict reaction rate changes with temperature and extrapolate shelf‑life from accelerated data

Q10. The Q10 method in shelf-life estimation refers to:

• The factor by which the degradation rate increases for every 10°C rise in temperature
• The quantum yield of photodegradation
• The ratio of water activity to relative humidity
• The tenth quality parameter in pharmacopoeia

Correct Answer: The factor by which the degradation rate increases for every 10°C rise in temperature

Q11. A stability‑indicating method is best described as an analytical procedure that:

• Only quantifies impurities
• Separates and quantifies the active marker in the presence of degradation products, impurities and excipients
• Measures viscosity changes over time
• Detects microbial contamination only

Correct Answer: Separates and quantifies the active marker in the presence of degradation products, impurities and excipients

Q12. For fermented ISM products such as arishta and asava, which parameter is especially monitored during stability studies?

• Alcohol/ethanol content and microbial profile
• Particle size
• Inorganic ash content only
• Heavy metal chelation capacity

Correct Answer: Alcohol/ethanol content and microbial profile

Q13. In the context of packaging selection for ISM formulations sensitive to oxidation, the most appropriate feature is:

• Opaque material with low oxygen transmission rate
• Transparent with high oxygen permeability
• Paper box with no lining
• Open jars to allow air exchange

Correct Answer: Opaque material with low oxygen transmission rate

Q14. Which kinetic order is most commonly assumed when a plot of log concentration vs time gives a straight line?

• Zero order
• First order
• Second order
• Pseudo-zero order

Correct Answer: First order

Q15. Typical acceptance criteria for assay of active marker during shelf-life for many herbal products is often reported as:

• 50–150% of label claim
• 90–110% of label claim
• 0–100% of label claim
• 110–130% of label claim

Correct Answer: 90–110% of label claim

Q16. Which microbiological tests are usually required as part of ISM finished product quality and stability?

• Total aerobic microbial count, total yeast & mold, absence of Salmonella and E. coli
• Only anaerobic bacterial count
• Only bacteriophage assays
• Only PCR for viral contaminants

Correct Answer: Total aerobic microbial count, total yeast & mold, absence of Salmonella and E. coli

Q17. Why is water activity (aw) measured for semi-solid or powdered ISM formulations?

• It has no relevance to stability
• To assess the potential for microbial growth and predict chemical stability related to moisture
• To determine the color of the product
• To calculate the molecular weight of actives

Correct Answer: To assess the potential for microbial growth and predict chemical stability related to moisture

Q18. When validating a stability study for an ISM product, regulatory guidance commonly expects stability data from how many primary batches?

• One pilot batch only
• Three primary production-scale batches
• Ten small laboratory batches
• No batches; only theoretical data

Correct Answer: Three primary production-scale batches

Q19. Photostability testing (light exposure) for an ISM formulation is required to:

• Assess the impact of light on active and to determine proper light-protective packaging if needed
• Sterilize the product
• Enhance flavor
• Increase shelf-life indefinitely

Correct Answer: Assess the impact of light on active and to determine proper light-protective packaging if needed

Q20. Which of the following best describes a common regulatory expectation when extrapolating shelf-life from accelerated stability data?

• Extrapolation is always sufficient without real-time data
• Accelerated data may support a tentative shelf-life but should be confirmed by real-time data and proper kinetic justification (e.g., Arrhenius or validated Q10)
• Accelerated data are never useful
• Only photostability data are required for shelf-life extrapolation

Correct Answer: Accelerated data may support a tentative shelf-life but should be confirmed by real-time data and proper kinetic justification (e.g., Arrhenius or validated Q10)

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