Parenteral products are sterile pharmaceutical preparations intended for administration by injection, infusion, or implantation, bypassing the gastrointestinal tract. This topic covers definitions, classification (SVP, LVP, depot), routes (intravenous, intramuscular, subcutaneous), formulation issues (sterility, tonicity, pH, preservatives), sterilization methods, aseptic processing, containers and closures, pyrogen control, particulate limits, and storage. B.Pharm students should master regulatory tests, sterilizing filters, lyophilization, and compatibility for safe clinical use. Clear understanding of manufacturing controls, validation, and contamination risks is essential for quality assurance in parenteral product development. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What best defines parenteral products?
- Medicinal products administered by injection that bypass the gastrointestinal tract.
- Oral dosage forms designed for rapid systemic absorption.
- Topical formulations applied to the skin for local action.
- Herbal remedies taken as dietary supplements.
Correct Answer: Medicinal products administered by injection that bypass the gastrointestinal tract.
Q2. Which is NOT a common parenteral route of administration?
- Intravenous
- Intramuscular
- Subcutaneous
- Buccal
Correct Answer: Buccal
Q3. Small volume parenterals (SVPs) are typically defined as:
- Parenterals with volume ≤100 mL
- Parenterals with volume >1000 mL
- Topical creams in sterile tubes
- Any parenteral product administered orally
Correct Answer: Parenterals with volume ≤100 mL
Q4. Which sterilization method is most suitable for heat-sensitive parenteral solutions containing biologicals?
- Autoclaving at 121°C
- Dry heat sterilization
- Filtration through a 0.22 μm membrane
- Gamma irradiation at high dose
Correct Answer: Filtration through a 0.22 μm membrane
Q5. What is the principal purpose of using 0.22 μm sterilizing-grade filters?
- Remove pyrogens from solution
- Sterilize by removing bacteria and larger microorganisms
- Adjust solution tonicity
- Enhance drug solubility
Correct Answer: Sterilize by removing bacteria and larger microorganisms
Q6. Terminal sterilization refers to:
- Sterilization of components before final filling
- Sterilizing the final sealed product in its container-closure system
- Aseptic filling in a cleanroom without further sterilization
- Using preservatives to maintain sterility during storage
Correct Answer: Sterilizing the final sealed product in its container-closure system
Q7. Which container-closure system is most suitable for lyophilized parenteral formulations?
- Plastic squeeze bottles
- Glass vials with rubber stoppers and flip-off seals
- Aluminum blister packs
- Unlaminated paper pouches
Correct Answer: Glass vials with rubber stoppers and flip-off seals
Q8. Pyrogens in parenteral products are primarily associated with which contaminant?
- Viral particles
- Endotoxins from gram-negative bacteria
- Particulate glass fragments
- Preservative residues
Correct Answer: Endotoxins from gram-negative bacteria
Q9. The Limulus Amebocyte Lysate (LAL) test is used to detect:
- Bacterial sterility
- Endotoxin levels
- Particulate matter
- Preservative potency
Correct Answer: Endotoxin levels
Q10. Which parameter is critical to adjust in parenteral formulations to avoid irritation on injection?
- Color
- Tonicity and pH
- Flavor
- Surface tension
Correct Answer: Tonicity and pH
Q11. Lyophilization (freeze-drying) is mainly used to:
- Increase solution viscosity
- Stabilize heat-labile drugs by removing water under low temperature
- Sterilize parenterals by freezing
- Enhance drug taste for oral use
Correct Answer: Stabilize heat-labile drugs by removing water under low temperature
Q12. Which preservative is commonly used in multi-dose parenteral formulations?
- Benzalkonium chloride
- Sodium chloride
- Polyethylene glycol 400
- Distilled water
Correct Answer: Benzalkonium chloride
Q13. Aseptic processing primarily differs from terminal sterilization because:
- Aseptic processing does not require sterile components
- Aseptic processing involves sterilizing ingredients separately and filling in a sterile environment
- Aseptic processing uses higher temperatures
- Aseptic processing is only for oral drugs
Correct Answer: Aseptic processing involves sterilizing ingredients separately and filling in a sterile environment
Q14. Which test is used to detect visible and subvisible particles in parenteral products?
- pH testing
- Particulate matter testing such as USP <788>
- Chromatography for impurities
- Osmolality measurement
Correct Answer: Particulate matter testing such as USP <788>
Q15. Which water grade is required for manufacturing most parenteral products?
- Purified water
- Water for Injection (WFI)
- Treated tap water
- Distilled water stored at room temperature
Correct Answer: Water for Injection (WFI)
Q16. Which statement about endotoxins is TRUE?
- Endotoxins can be removed by autoclaving alone
- Endotoxins are thermostable and require specific removal methods
- Endotoxins are only produced during sterilization
- Endotoxins are harmless pyrogenic substances
Correct Answer: Endotoxins are thermostable and require specific removal methods
Q17. Depot injections are designed to:
- Deliver immediate high plasma concentrations only
- Provide sustained or controlled release of drug over time
- Be administered orally for long effect
- Serve as topical anesthetics
Correct Answer: Provide sustained or controlled release of drug over time
Q18. Which cleanroom ISO grade is commonly used for critical aseptic filling zones (e.g., filling area)?
- ISO 9
- ISO 7 or ISO 5 for critical zones
- ISO 3 for all operations
- ISO 1 for personnel only
Correct Answer: ISO 7 or ISO 5 for critical zones
Q19. Which incompatibility is most concerning for intravenous admixtures?
- Color matching
- Precipitation and phlebitis risk
- Flavor alteration
- Packaging label mismatch
Correct Answer: Precipitation and phlebitis risk
Q20. For sterilizing dry heat (e.g., glassware), which condition is commonly used?
- 160–180°C for specified time
- 121°C for 15 minutes under pressure
- 25°C ambient for 48 hours
- Boiling at 100°C for 5 minutes
Correct Answer: 160–180°C for specified time
Q21. Which factor affects stability of parenteral emulsions?
- Surface color of the packaging
- Emulsifier type, droplet size, and storage temperature
- Patient age only
- Number of administrations per day
Correct Answer: Emulsifier type, droplet size, and storage temperature
Q22. Which assay is used to confirm sterility of a parenteral batch?
- Sterility test based on incubation in growth media
- pH titration
- UV-spectrophotometry for concentration
- Viscosity measurement
Correct Answer: Sterility test based on incubation in growth media
Q23. What is the primary risk associated with particulate contamination in parenterals?
- Increased flavor intensity
- Thrombosis, embolism, and local tissue irritation
- Faster drug absorption orally
- Improved sterility
Correct Answer: Thrombosis, embolism, and local tissue irritation
Q24. Which preservative is generally avoided in neonatal parenteral formulations?
- Phenol
- Benzyl alcohol
- Sodium chloride
- Water for injection
Correct Answer: Benzyl alcohol
Q25. Filter integrity testing after filtration is used to:
- Measure drug potency
- Confirm that the sterilizing filter remained intact and functional
- Adjust pH of filtered solution
- Determine endotoxin levels directly
Correct Answer: Confirm that the sterilizing filter remained intact and functional
Q26. Which factor is most important when selecting a diluent for reconstituting a lyophilized parenteral?
- Color of the diluent
- Compatibility, pH, tonicity, and sterility
- Manufacturer’s logo
- Packaging material weight
Correct Answer: Compatibility, pH, tonicity, and sterility
Q27. Which statement about multi-dose vials is CORRECT?
- They never require preservatives
- They may contain preservatives to prevent microbial growth after puncture
- They must be used immediately and cannot be stored
- They are always terminally sterilized after each use
Correct Answer: They may contain preservatives to prevent microbial growth after puncture
Q28. Which is the main advantage of intravenous (IV) administration for parenterals?
- Slow onset of action
- Complete and immediate bioavailability
- Avoidance of sterility requirements
- Better taste for the patient
Correct Answer: Complete and immediate bioavailability
Q29. Which test ensures that a vial’s rubber stopper seals properly after lyophilization?
- pH measurement
- Container-closure integrity testing
- Visual color inspection only
- Viscosity check
Correct Answer: Container-closure integrity testing
Q30. What is the role of a buffer in a parenteral formulation?
- To change the drug’s color
- To maintain pH for drug stability and compatibility
- To sterilize the solution
- To increase particulate formation
Correct Answer: To maintain pH for drug stability and compatibility
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.
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