Formulation of injections MCQs With Answer is a focused review designed for B. Pharm students to master parenteral dosage form principles. This set covers sterile formulation, aseptic processing, sterilization methods, isotonicity, buffering, preservatives, vehicles, and container-closure systems. Emphasis is placed on stability, pyrogen and endotoxin testing, lyophilization, particulate control, IV compatibility, and formulation troubleshooting. Each question links practical formulation requirements with regulatory and quality control concepts to build competence in preparing safe injectable products. Ideal for exam preparation and practical lab understanding, these MCQs reinforce critical thinking on real-world issues encountered during injectable product development. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which statement best defines a parenteral injection?
- Administration of a drug through the gastrointestinal tract
- Administration of a drug by inhalation into the lungs
- Administration of a drug by any route other than the alimentary canal, commonly by injection
- Administration of a drug through topical skin application
Correct Answer: Administration of a drug by any route other than the alimentary canal, commonly by injection
Q2. What is the primary purpose of making an injectable formulation isotonic?
- To enhance the drug’s chemical stability
- To prevent local tissue irritation and hemolysis
- To increase drug solubility
- To sterilize the formulation
Correct Answer: To prevent local tissue irritation and hemolysis
Q3. Which sterilization method is most suitable for heat-sensitive injectable solutions containing small molecules?
- Autoclaving at 121°C for 15 minutes
- Dry heat sterilization at 160°C
- Filtration through a 0.22 µm sterilizing-grade membrane
- Gamma irradiation
Correct Answer: Filtration through a 0.22 µm sterilizing-grade membrane
Q4. Which container-closure system is preferred for single dose parenteral products to avoid preservative use?
- Multi-dose glass vial with rubber stopper
- Single-dose glass ampoule
- Plastic bottle with screw cap
- Ointment tube
Correct Answer: Single-dose glass ampoule
Q5. Which preservative is commonly used in multi-dose vials of aqueous injections?
- Sodium chloride
- Benzyl alcohol
- Methanol
- Glycerin
Correct Answer: Benzyl alcohol
Q6. Why is buffering important in injectable formulations?
- To increase viscosity of the solution
- To maintain pH for drug stability and compatibility with tissues
- To make the solution isotonic
- To act as a preservative
Correct Answer: To maintain pH for drug stability and compatibility with tissues
Q7. Which test specifically detects bacterial endotoxin contamination in injectable products?
- Sterility test using culture media
- pH determination
- Limulus Amebocyte Lysate (LAL) test
- Visual inspection for particulates
Correct Answer: Limulus Amebocyte Lysate (LAL) test
Q8. Lyophilization (freeze-drying) of injectable drugs is primarily used to:
- Increase the viscosity for slow release
- Convert crystalline drug to amorphous form for oral delivery
- Improve stability of labile drugs by removing water and producing a dry cake
- Sterilize the product by freezing
Correct Answer: Improve stability of labile drugs by removing water and producing a dry cake
Q9. What is a common vehicle for oil-based injectable formulations?
- Propylene glycol
- Sterile water for injection
- Soybean oil or sesame oil
- Ethanol 95%
Correct Answer: Soybean oil or sesame oil
Q10. Which property of the formulation most directly affects its compatibility with blood upon intravenous administration?
- Color of the solution
- pH and osmolality
- Container material color
- Storage temperature
Correct Answer: pH and osmolality
Q11. Which particulate control test is critical for injectable formulations?
- Friability testing
- Particulate matter counting using light obscuration
- Disintegration time
- Melting point determination
Correct Answer: Particulate matter counting using light obscuration
Q12. A terminal sterilization method capable of achieving SAL 10^-6 for many parenterals is:
- Sterile filtration only
- Autoclaving (steam sterilization)
- Use of preservatives
- Lyophilization
Correct Answer: Autoclaving (steam sterilization)
Q13. Which membrane pore size is standard for sterilizing filtration of solutions?
- 1.2 µm
- 0.45 µm
- 0.22 µm
- 5.0 µm
Correct Answer: 0.22 µm
Q14. What is the main risk associated with using glass ampoules for injections?
- Risk of leaching plasticizers
- Risk of microbial growth inside ampoules
- Risk of glass particle contamination upon opening
- Incompatibility with aqueous drugs
Correct Answer: Risk of glass particle contamination upon opening
Q15. Which factor most commonly causes turbidity or precipitation in an injectable formulation after storage?
- Correct isotonic adjustment
- pH change leading to drug precipitation
- Proper sterilization
- Use of appropriate preservatives
Correct Answer: pH change leading to drug precipitation
Q16. For a multi-dose injectable vial, which container attribute is critical to prevent microbial ingress during repeated needle insertions?
- Thickness of glass
- Rubber stopper integrity and self-sealing property
- Color of label
- Size of vial cap
Correct Answer: Rubber stopper integrity and self-sealing property
Q17. Which excipient is commonly used to adjust tonicity in injectable preparations?
- Sodium chloride
- Sodium acetate at high concentration
- Polysorbate 80
- Bentonite
Correct Answer: Sodium chloride
Q18. A formulation scientist chooses a surfactant like polysorbate 80 in an injectable emulsion primarily to:
- Increase the solution pH
- Act as an antimicrobial preservative
- Stabilize the oil-water interface and prevent creaming or coalescence
- Promote crystallization of the drug
Correct Answer: Stabilize the oil-water interface and prevent creaming or coalescence
Q19. Which is a critical validation parameter for aseptic processing of injectables?
- Brightness of manufacturing lights
- Media fill (process simulation) to demonstrate aseptic technique
- Employee job titles
- Color of personnel garments
Correct Answer: Media fill (process simulation) to demonstrate aseptic technique
Q20. Why are chelating agents like EDTA sometimes included in injectable formulations?
- To act as primary sterilant
- To chelate metal ions that catalyze degradation or support microbial growth
- To increase viscosity
- To provide isotonicity
Correct Answer: To chelate metal ions that catalyze degradation or support microbial growth
Q21. Which phenomenon describes loss of drug potency due to adsorption onto container surfaces?
- Leaching
- Adsorption
- Osmosis
- Cryoprotection
Correct Answer: Adsorption
Q22. What is the main regulatory requirement for visible particulate matter in injectable solutions intended for parenteral use?
- Any visible particle is acceptable if sterile
- Strict limits and rejection of product batches showing visible particulate matter
- Only color change matters, not particulates
- Particulates are acceptable for intramuscular use
Correct Answer: Strict limits and rejection of product batches showing visible particulate matter
Q23. Which analytical test is used to confirm sterility of an injectable batch?
- pH measurement
- Culturing samples in growth media for specified incubation periods
- Osmolality testing
- Density measurement
Correct Answer: Culturing samples in growth media for specified incubation periods
Q24. For an oil-in-water parenteral emulsion, what parameter is most important to monitor for long-term stability?
- Viscosity only at time zero
- Droplet size distribution to prevent coalescence and phase separation
- Color of the vial cap
- Amount of ethanol present
Correct Answer: Droplet size distribution to prevent coalescence and phase separation
Q25. Which preservative is often avoided in neonates due to toxicity concerns?
- Chlorobutanol
- Benzalkonium chloride
- Benzyl alcohol
- Disodium EDTA
Correct Answer: Benzyl alcohol
Q26. What is a common cause of incompatibility when mixing drugs in the same IV line?
- Matching pH values
- Precipitation due to ionic interactions or pH differences
- Using the same syringe type
- Similar color of solutions
Correct Answer: Precipitation due to ionic interactions or pH differences
Q27. Which parameter is most indicative of successful removal of pyrogens from a parenteral product?
- Freezing point depression
- Low endotoxin level measured by LAL within pharmacopeial limits
- High viscosity
- Clear colorless appearance
Correct Answer: Low endotoxin level measured by LAL within pharmacopeial limits
Q28. Why might a formulation include a tonicity agent other than sodium chloride, such as dextrose?
- To act as a preservative
- To provide caloric supply and adjust tonicity when sodium load must be limited
- To increase sterilization efficiency
- To enhance color stability
Correct Answer: To provide caloric supply and adjust tonicity when sodium load must be limited
Q29. Which statement about sterilizing filtration of protein therapeutics is true?
- All proteins pass through 0.22 µm membranes without loss
- Filtration can cause protein adsorption or shear-induced aggregation, requiring filter selection and validation
- Filtration sterilizes by killing bacteria
- Filter pore size should always be increased to 5 µm for proteins
Correct Answer: Filtration can cause protein adsorption or shear-induced aggregation, requiring filter selection and validation
Q30. During formulation development, forced degradation studies for injectables are performed to:
- Determine packaging color
- Identify degradation pathways, establish stability-indicating assays, and define storage conditions
- Replace sterility testing
- Increase drug potency intentionally
Correct Answer: Identify degradation pathways, establish stability-indicating assays, and define storage conditions
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