Parenteral formulations require strict control of sterility, stability, safety, and compatibility to ensure patient safety and therapeutic efficacy. This concise resource covers essential requirements for parenteral formulations MCQs with answer, focusing on sterility assurance, pyrogen control, sterilization methods, container–closure systems, water for injection, tonicity, pH, preservatives, particulate limits, and stability testing. Each question emphasizes practical aspects B.Pharm students must master—such as filter pore sizes, autoclave parameters, aseptic processing, and packaging materials like Type I glass—helping you bridge theory and lab practice. Keywords: parenteral formulations, sterility, pyrogens, WFI, depyrogenation, aseptic processing, isotonicity. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which of the following is a parenteral route of administration?
- Oral
- Intravenous
- Topical
- Ocular
Correct Answer: Intravenous
Q2. Which document or test is commonly used to detect bacterial endotoxins in parenteral preparations?
- USP Particulate Test
- Limulus Amebocyte Lysate (LAL) test
- pH titration
- UV-Visible spectrophotometry
Correct Answer: Limulus Amebocyte Lysate (LAL) test
Q3. What pore size is generally regarded as sterilizing-grade for membrane filtration of parenteral solutions?
- 1.2 μm
- 0.45 μm
- 0.22 μm
- 0.05 μm
Correct Answer: 0.22 μm
Q4. Which sterilization method is most appropriate for heat-sensitive aqueous protein solutions?
- Autoclaving at 121°C
- Dry heat sterilization
- Filtration through a sterilizing-grade membrane
- Boiling
Correct Answer: Filtration through a sterilizing-grade membrane
Q5. Which container material is preferred for many parenteral formulations due to chemical resistance and low extractables?
- Type I borosilicate glass
- Low-density polyethylene (LDPE)
- Aluminum foil
- Cardboard
Correct Answer: Type I borosilicate glass
Q6. Which practice is classified as terminal sterilization?
- Aseptic filling into pre-sterilized vials
- Steam sterilization of the filled and sealed final container
- Filter sterilizing the bulk solution before filling
- Sterilizing equipment only
Correct Answer: Steam sterilization of the filled and sealed final container
Q7. The main source of pyrogens in parenteral products is:
- Viral contaminants
- Endotoxins from Gram-negative bacteria
- Inorganic impurities
- Volatile solvents
Correct Answer: Endotoxins from Gram-negative bacteria
Q8. For preventing microbial growth in multi-dose parenteral formulations, what is commonly incorporated?
- Preservatives
- Antioxidants only
- Bulking agents
- Colorants
Correct Answer: Preservatives
Q9. Which of the following is a critical parameter to control for parenteral compatibility with blood and tissues?
- pH and isotonicity
- Color of the solution
- Molar mass of excipients
- Surface tension only
Correct Answer: pH and isotonicity
Q10. Which water type is specifically required for preparing parenteral formulations?
- Purified water
- Distilled water
- Water for Injection (WFI)
- Tap water
Correct Answer: Water for Injection (WFI)
Q11. Depyrogenation of glassware is most effectively achieved by which method?
- Autoclaving with steam
- Dry heat at validated temperatures
- Chemical washing with sodium chloride
- Ultrasonic cleaning only
Correct Answer: Dry heat at validated temperatures
Q12. Which test is typically used to assess sub-visible particulates in parenteral solutions?
- pH meter
- Light obscuration particle count
- Thin-layer chromatography
- Viscometry
Correct Answer: Light obscuration particle count
Q13. Why is tonicity adjustment important in parenteral formulations?
- To improve color stability
- To prevent tissue irritation and hemolysis
- To increase the molecular weight of actives
- To reduce viscosity exclusively
Correct Answer: To prevent tissue irritation and hemolysis
Q14. Which aseptic processing step is critical to maintain sterility during filling?
- Using non-sterile air for laminar flow
- Personnel gowning and controlled environment
- Leaving vials open during transfer
- Working outside of cleanrooms
Correct Answer: Personnel gowning and controlled environment
Q15. Lyophilization (freeze-drying) is primarily used in parenteral formulations to:
- Increase solution viscosity
- Enhance solubility of insoluble drugs
- Improve stability of thermolabile drugs as a dry product
- Color-match the product to packaging
Correct Answer: Improve stability of thermolabile drugs as a dry product
Q16. Which preservative is contraindicated in neonates due to toxicity concerns?
- Benzalkonium chloride
- Benzyl alcohol
- Phenol
- Chlorobutanol
Correct Answer: Benzyl alcohol
Q17. Which parameter is most commonly used to demonstrate container-closure integrity?
- Color matching
- Helium leak or vacuum decay testing
- Measuring glass thickness only
- Visual inspection of label
Correct Answer: Helium leak or vacuum decay testing
Q18. What is the main advantage of terminal sterilization over aseptic processing?
- Lower equipment cost
- Higher sterility assurance when applicable
- No need for validation
- Better for heat-sensitive drugs
Correct Answer: Higher sterility assurance when applicable
Q19. Which excipient is commonly used to adjust tonicity in parenteral formulations?
- Sucrose often alone
- Sodium chloride
- Magnesium stearate
- Polyethylene glycol 400
Correct Answer: Sodium chloride
Q20. Which of the following is a sign of incompatibility in parenteral admixtures?
- Clear solution remaining unchanged
- Precipitation or color change
- Maintenance of pH
- Unchanged osmolarity
Correct Answer: Precipitation or color change
Q21. Which sterilization method is appropriate for single-use medical devices and some parenteral container closures?
- Gamma irradiation
- Boiling in water
- Soda cleaning
- Room temperature air exposure
Correct Answer: Gamma irradiation
Q22. What is a key reason to avoid preservatives in many single-dose parenteral vials?
- Preservatives increase osmolarity significantly
- Regulatory and safety preference for preservative-free single-dose products
- Preservatives cause discoloration in single doses
- They are too expensive
Correct Answer: Regulatory and safety preference for preservative-free single-dose products
Q23. What does the term “aseptic processing” refer to in parenteral manufacturing?
- Filling and sealing of sterile product in a sterile environment without terminal sterilization
- Only sterilizing equipment components
- Using preservatives to maintain sterility
- Sterilizing final sealed containers with steam
Correct Answer: Filling and sealing of sterile product in a sterile environment without terminal sterilization
Q24. Which analytical parameter is critical during stability testing of parenteral products?
- Appearance, potency, pH, and particulate matter
- Packaging color only
- Label font size
- Supplier location
Correct Answer: Appearance, potency, pH, and particulate matter
Q25. Which microorganism test approach is often used for sterility testing of aqueous parenteral products?
- Membrane filtration sterility test
- Gas chromatography
- Mass spectrometry
- pH titration
Correct Answer: Membrane filtration sterility test
Q26. Which factor must be demonstrated for an ingredient used in parenteral formulations?
- Non-toxicity and low levels of extractables/leachables
- Attractive color only
- High volatility
- Incompatibility with water
Correct Answer: Non-toxicity and low levels of extractables/leachables
Q27. What is the role of pH control in parenteral formulations?
- Only to adjust color
- To maintain drug stability and minimize tissue irritation
- To lower viscosity only
- To increase bacterial growth intentionally
Correct Answer: To maintain drug stability and minimize tissue irritation
Q28. Which practice helps reduce endotoxin contamination during manufacturing?
- Using non-validated cleaning processes
- Implementing validated depyrogenation and using pyrogen-free materials
- Storing components in open containers
- Avoiding monitoring of water quality
Correct Answer: Implementing validated depyrogenation and using pyrogen-free materials
Q29. For intravenous admixtures, Y-site incompatibility testing is important because:
- It ensures the product smells pleasant
- Mixed drugs at the Y-site can precipitate or inactivate each other
- It helps color match infusion sets
- It measures the infusion pump accuracy
Correct Answer: Mixed drugs at the Y-site can precipitate or inactivate each other
Q30. Which regulatory requirement is essential for commercial parenteral products before marketing?
- Demonstration of sterility, stability, and validated manufacturing process
- Only a marketing plan
- No testing if produced in small batches
- Only animal testing without validation
Correct Answer: Demonstration of sterility, stability, and validated manufacturing process
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