Advantages and limitations of parenteral products MCQs With Answer

Advantages and limitations of parenteral products MCQs With Answer is an essential topic for B. Pharm students studying sterile dosage forms. This introduction covers key concepts such as parenteral routes (IV, IM, SC, intrathecal), sterile formulations, aseptic processing, stability, compatibility, dosing accuracy, bioavailability, immunogenicity, particulate contamination, preservatives, and packaging types (ampoules, vials, prefilled syringes). Understanding benefits like rapid onset, predictable absorption and complete bioavailability alongside limitations—infection risk, pain, need for sterility, incompatibilities and storage challenges—prepares students for safe formulation, handling and clinical use. Practical MCQs reinforce critical thinking for quality control, regulatory compliance and patient safety. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which parenteral route provides the fastest systemic drug effect?

• Intramuscular injection
• Subcutaneous injection
• Intravenous injection
• Intradermal injection

Correct Answer: Intravenous injection

Q2. Which is a major advantage of parenteral administration over oral delivery?

• Lower cost of therapy
• Bypasses first-pass metabolism
• Better patient acceptability for chronic therapy
• Improved taste masking

Correct Answer: Bypasses first-pass metabolism

Q3. What is a common limitation associated with parenteral products?

• High tolerance for microbial contamination
• Requirement for sterility and aseptic technique
• Increased gastrointestinal degradation
• Unreliable dosing accuracy

Correct Answer: Requirement for sterility and aseptic technique

Q4. Which formulation type is typically used for proteins and peptides to improve stability for parenteral use?

• Simple aqueous solutions without excipients
• Lyophilized (freeze-dried) powders for reconstitution
• Oral tablets
• Topical creams

Correct Answer: Lyophilized (freeze-dried) powders for reconstitution

Q5. Which sterilization method is most suitable for heat-sensitive parenteral solutions?

• Autoclaving (steam sterilization)
• Dry heat sterilization
• Membrane filtration (0.22 μm)
• Moist heat at high temperature

Correct Answer: Membrane filtration (0.22 μm)

Q6. Which container type reduces the risk of air contamination after reconstitution for parenteral products?

• Single-dose ampoule
• Multi-dose vial without preservative
• Glass bottle with cork
• Non-sterile jar

Correct Answer: Single-dose ampoule

Q7. Which excipient is commonly used as a preservative in multi-dose parenteral vials?

• Benzalkonium chloride
• Sodium chloride
• Benzyl alcohol
• Polysorbate 80 as main preservative

Correct Answer: Benzyl alcohol

Q8. What is a critical limitation when using preservatives in neonatal parenteral formulations?

• Preservatives improve oxygen stability in neonates
• Preservatives often cause increased bioavailability
• Potential toxicity and metabolic immaturity in neonates
• Preservatives always prevent particulate formation

Correct Answer: Potential toxicity and metabolic immaturity in neonates

Q9. Which parameter is most important to control to prevent venous irritation with intravenous infusions?

• pH and osmolarity of the solution
• Colour of the infusion bag
• Time of day of administration
• Patient body mass index only

Correct Answer: pH and osmolarity of the solution

Q10. Which type of incompatibility may cause precipitation when two parenteral solutions are mixed?

• Chemical incompatibility due to ionic reactions
• Temperature incompatibility only
• Light-induced colour change only
• Packaging color incompatibility

Correct Answer: Chemical incompatibility due to ionic reactions

Q11. Which test detects endotoxin contamination in parenteral products?

• Sterility test
• Particulate matter test
• LAL (Limulus Amebocyte Lysate) test
• pH measurement

Correct Answer: LAL (Limulus Amebocyte Lysate) test

Q12. Which parenteral product attribute is most directly linked to rapid therapeutic action?

• Low osmolarity
• High oral bioavailability
• Complete systemic bioavailability
• Presence of preservatives

Correct Answer: Complete systemic bioavailability

Q13. Which material used for infusion bags may adsorb lipophilic drugs, causing dose loss?

• Polyethylene (PE) rigid containers
• Polyvinyl chloride (PVC) plasticized with DEHP
• Glass ampoules
• Stainless steel bottles

Correct Answer: Polyvinyl chloride (PVC) plasticized with DEHP

Q14. What is a key advantage of prefilled syringes for parenteral administration?

• They always eliminate need for preservatives
• Reduce dosing errors and improve aseptic convenience
• Increase product shelf life indefinitely
• Reduce manufacturing costs significantly

Correct Answer: Reduce dosing errors and improve aseptic convenience

Q15. Which parenteral route is preferred for slow, sustained absorption of drugs?

• Intravenous bolus
• Intradermal injection
• Intramuscular depot injection
• Transdermal patch (non-parenteral)

Correct Answer: Intramuscular depot injection

Q16. Which phenomenon describes leaching of container additives into parenteral drug solutions?

• Adsorption
• Leachables and extractables
• Osmotic shock
• Vaporization

Correct Answer: Leachables and extractables

Q17. Which is a regulatory requirement for parenteral manufacturing facilities?

• No need for environmental monitoring
• Validated aseptic processing and cleanroom classification
• Only visual inspection of final product is needed
• Flexible room pressure without documentation

Correct Answer: Validated aseptic processing and cleanroom classification

Q18. Which property of glass vials can present a limitation for parenteral products?

• Complete impermeability to gases
• Risk of delamination and particulate glass shards
• Absence of interaction with drug molecules
• Elasticity leading to deformation under pressure

Correct Answer: Risk of delamination and particulate glass shards

Q19. What is the main purpose of adding tonicity agents in parenteral solutions?

• Increase chemical reactivity
• Match osmotic pressure with body fluids to reduce irritation
• Promote microbial growth
• Enhance coloration of the solution

Correct Answer: Match osmotic pressure with body fluids to reduce irritation

Q20. Which analytical test is critical for detecting visible and subvisible particles in parenteral products?

• pH meter
• Particle counting by light obscuration and microscopy
• Viscosity measurement only
• Colourimetric assay

Correct Answer: Particle counting by light obscuration and microscopy

Q21. Which statement correctly describes terminal sterilization compared to aseptic processing?

• Terminal sterilization is applied before filling
• Terminal sterilization sterilizes the final sealed product, often more robust than aseptic filling
• Aseptic processing always provides higher sterility assurance than terminal sterilization
• Terminal sterilization cannot be validated

Correct Answer: Terminal sterilization sterilizes the final sealed product, often more robust than aseptic filling

Q22. Which factor often limits the use of intravenous lipid emulsions?

• Complete chemical inertness
• Risk of emulsion instability, microbial growth and fat overload
• Inability to carry lipophilic drugs
• Excessively low caloric value

Correct Answer: Risk of emulsion instability, microbial growth and fat overload

Q23. Which incompatibility occurs when an antibiotic is mixed with heparin in the same IV line causing reduced activity?

• Photodegradation
• Chemical/physical incompatibility leading to inactivation or precipitation
• Improved potency of both drugs
• Enhanced solubility of both drugs

Correct Answer: Chemical/physical incompatibility leading to inactivation or precipitation

Q24. What is the role of surfactants like polysorbate 80 in parenteral formulations?

• Increase microbial growth
• Act as stabilizers to prevent protein aggregation and surface adsorption
• Decrease solubility of the active ingredient
• Promote glass delamination

Correct Answer: Act as stabilizers to prevent protein aggregation and surface adsorption

Q25. Which condition is a critical cause of pyrogenicity in parenteral products?

• Presence of residual solvent only
• Endotoxin contamination from Gram-negative bacteria
• High sugar content
• Use of non-sterile primary packaging color

Correct Answer: Endotoxin contamination from Gram-negative bacteria

Q26. Which practice reduces the risk of particulate contamination during aseptic filling?

• Opening ampoules in a non-clean area
• Using validated closed-system transfers and HEPA-filtered laminar airflow
• Reusing syringes between batches
• Skipping filter integrity testing

Correct Answer: Using validated closed-system transfers and HEPA-filtered laminar airflow

Q27. In stability studies of parenteral products, which parameter is most indicative of chemical degradation?

• Change in container color only
• Assay of active content and impurity profiling by validated methods
• Room lighting conditions
• Size of the production batch

Correct Answer: Assay of active content and impurity profiling by validated methods

Q28. Which property of a parenteral antibiotic formulation can lead to thrombophlebitis if incorrect?

• Sterility assurance level only
• pH and osmolarity incompatible with blood vessels
• Use of glass vials only
• Low potency of the antibiotic

Correct Answer: pH and osmolarity incompatible with blood vessels

Q29. Which is a limitation when using glass ampoules for parenteral products?

• Inability to maintain sterility
• Risk of glass particle contamination and need for careful opening technique
• Excessive gas permeability
• Incompatibility with aqueous solutions

Correct Answer: Risk of glass particle contamination and need for careful opening technique

Q30. For protein parenterals, which strategy helps reduce immunogenicity risk?

• Adding ionic impurities
• Maintaining product aggregates and particles
• Minimizing aggregates, optimizing formulation pH and using stabilizers
• Using high sugar concentrations without validation

Correct Answer: Minimizing aggregates, optimizing formulation pH and using stabilizers

G S Sachin

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