Introduction: Schedule P is a key regulatory topic for B.Pharm students focusing on pharmaceutical stability requirements, stability testing protocols, and documentation needed to establish shelf life. This subject covers accelerated testing, long-term studies, forced degradation, photostability, packaging and container-closure interactions, and criteria for stability-indicating methods. Understanding Schedule P helps students learn how environmental factors, formulation variables and regulatory guidelines influence drug potency, safety and labeling. Mastery of Schedule P concepts—such as stability study design, storage conditions, extrapolation of expiry and stability documentation—is essential for quality assurance, regulatory submissions and product lifecycle management. ‘Now let’s test your knowledge with 30 MCQs on this topic.’
Q1. What is the primary focus of Schedule P in pharmaceutical education?
- Guidance on marketing strategies for pharmacists
- Requirements and protocols for pharmaceutical stability testing
- Standards for compounding sterile products
- Guidelines for clinical trial design
Correct Answer: Requirements and protocols for pharmaceutical stability testing
Q2. Which of the following best describes the purpose of stability testing?
- To evaluate product taste over time
- To determine how formulation, packaging and storage affect drug quality over time
- To measure manufacturing throughput
- To assess marketing potential of a drug
Correct Answer: To determine how formulation, packaging and storage affect drug quality over time
Q3. Which study type is designed to predict long-term product behavior using elevated conditions for a short time?
- Real-time stability study
- Accelerated stability study
- Microbial challenge study
- In-use study
Correct Answer: Accelerated stability study
Q4. Which environmental factor is commonly controlled during stability testing and strongly influences hydrolytic degradation?
- Light intensity
- Relative humidity
- Magnetic field
- Sound level
Correct Answer: Relative humidity
Q5. Photostability testing of a drug product is primarily intended to assess what?
- Thermal decomposition due to high heat
- Chemical changes induced by light exposure
- Microbial contamination under storage
- Mechanical stability during transport
Correct Answer: Chemical changes induced by light exposure
Q6. Which set of stress conditions is typically included in forced degradation studies?
- Cold, silence, vacuum
- Hydrolysis, oxidation, photolysis, thermal stress
- Compression, vibration, UV sterilization
- pH neutralization only
Correct Answer: Hydrolysis, oxidation, photolysis, thermal stress
Q7. What is a “stability-indicating method”?
- An assay that only measures excipient content
- A test that can accurately and selectively quantify the active and separate degradation products
- A marketing tool for claiming extended shelf life
- A method to count microbial colonies
Correct Answer: A test that can accurately and selectively quantify the active and separate degradation products
Q8. Which packaging feature is most important to control moisture-sensitive drug degradation?
- Color of box printing
- Water vapor transmission rate (WVTR) of the container
- Shape of the bottle cap
- Font size on the label
Correct Answer: Water vapor transmission rate (WVTR) of the container
Q9. Which of the following is a typical accelerated stability condition used in many stability protocols?
- 0°C and 10% RH
- 40°C and 75% RH
- 60°C and 20% RH
- 15°C and 50% RH
Correct Answer: 40°C and 75% RH
Q10. The Arrhenius equation is applied in stability studies for what purpose?
- To model microbial kill curves
- To predict reaction rate changes with temperature and help estimate shelf life
- To determine tablet hardness
- To set packaging color codes
Correct Answer: To predict reaction rate changes with temperature and help estimate shelf life
Q11. Which kinetic order implies a constant degradation rate independent of drug concentration?
- First-order kinetics
- Second-order kinetics
- Zero-order kinetics
- Pseudo-first-order kinetics
Correct Answer: Zero-order kinetics
Q12. In stability protocol design, “bracketing” refers to which approach?
- Testing only the smallest and largest strengths or pack sizes instead of every strength
- Testing all possible combinations of excipients
- Testing only under refrigeration
- Performing microbiological assays only
Correct Answer: Testing only the smallest and largest strengths or pack sizes instead of every strength
Q13. Which documentation is essential to support shelf life claims?
- Marketing brochures
- Complete stability study reports and raw data
- Purchase orders of raw materials
- Patient feedback forms
Correct Answer: Complete stability study reports and raw data
Q14. For multi-dose liquid formulations, which test evaluates preservative efficacy over time?
- Forced degradation test
- Preservative efficacy (challenge) test
- Opacity measurement
- pH titration only
Correct Answer: Preservative efficacy (challenge) test
Q15. Which parameter commonly indicates physical instability in a suspension?
- Change in color of the cap
- Significant change in particle size or sedimentation behavior
- Increase in label font size
- Decrease in marketing claims
Correct Answer: Significant change in particle size or sedimentation behavior
Q16. What is the main goal of in-use stability studies?
- To evaluate product stability during actual use after opening or reconstitution
- To determine manufacturing cycle time
- To measure bulk powder compressibility
- To assess staff training requirements
Correct Answer: To evaluate product stability during actual use after opening or reconstitution
Q17. Which guideline specifically addresses photostability testing of new drug substances and products?
- ICH Q1A
- ICH Q1B
- ICH Q2(R1)
- ICH Q8
Correct Answer: ICH Q1B
Q18. During stability testing, the term “commitment batches” usually refers to what?
- Batches reserved for marketing samples
- Batches held for long-term stability testing after product approval
- Batches used for training manufacturing staff
- Batches discarded after QC release
Correct Answer: Batches held for long-term stability testing after product approval
Q19. Why are excipient compatibility studies important in stability evaluation?
- To optimize tablet appearance only
- To determine if excipients interact with the active and affect stability
- To select the cheapest excipients
- To identify suppliers
Correct Answer: To determine if excipients interact with the active and affect stability
Q20. Which analytical approach is preferred to detect low levels of degradation products?
- Non-specific titration
- High-performance liquid chromatography (HPLC) with stability-indicating conditions
- Visual inspection only
- Bulk density measurement
Correct Answer: High-performance liquid chromatography (HPLC) with stability-indicating conditions
Q21. Which factor most directly affects oxidative degradation of a drug?
- Presence of oxygen and pro-oxidants
- Tablet shape
- Label color
- Production shift timing
Correct Answer: Presence of oxygen and pro-oxidants
Q22. What is the significance of “container-closure integrity” in stability?
- It ensures the label is glued properly
- It prevents ingress of moisture, oxygen or microbes and maintains therapeutic quality
- It improves marketing appeal
- It measures tablet disintegration
Correct Answer: It prevents ingress of moisture, oxygen or microbes and maintains therapeutic quality
Q23. When a drug follows first-order degradation kinetics, what happens to the rate of degradation as concentration decreases?
- The rate remains constant
- The rate increases
- The rate decreases proportionally with concentration
- The rate becomes unpredictable
Correct Answer: The rate decreases proportionally with concentration
Q24. Which stability study provides data under recommended storage conditions for shelf life assignment?
- Stress testing
- Real-time (long-term) stability study
- Accelerated study only
- Marketing surveillance
Correct Answer: Real-time (long-term) stability study
Q25. In stability reports, “specification” refers to what?
- Acceptable limits or criteria for quality attributes
- Packaging dimensions only
- Supplier contact details
- Batch manufacturing location
Correct Answer: Acceptable limits or criteria for quality attributes
Q26. Which of the following is a common indicator that a liquid formulation has undergone chemical degradation?
- Increase in viscosity only
- Change in pH, color or appearance
- Weight of the bottle decreases
- Label peeling
Correct Answer: Change in pH, color or appearance
Q27. Why is accelerated stability data used with caution when assigning expiry dates?
- Because accelerated studies are always identical to real-time results
- Because accelerated conditions can induce degradation pathways not relevant at normal storage and require confirmation by real-time data
- Because accelerated studies are cheaper
- Because accelerated data replaces the need for any long-term testing
Correct Answer: Because accelerated conditions can induce degradation pathways not relevant at normal storage and require confirmation by real-time data
Q28. Which test assesses a formulation’s susceptibility to moisture uptake?
- HPLC assay
- Deliquescence and moisture sorption studies
- Visual color charting
- Tablet friability only
Correct Answer: Deliquescence and moisture sorption studies
Q29. What is the role of antioxidants in formulations?
- To enhance flavor
- To inhibit oxidative degradation of sensitive actives
- To increase tablet hardness
- To act as primary preservatives against microbes
Correct Answer: To inhibit oxidative degradation of sensitive actives
Q30. Which practice improves the reliability of stability study conclusions?
- Using a single accelerated data point only
- Including multiple batches, replicates and appropriate analytical validation
- Skipping method validation to save time
- Relying solely on visual inspection
Correct Answer: Including multiple batches, replicates and appropriate analytical validation
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