Introduction: Understanding the objectives of size separation MCQs with answer is essential for B. Pharm students focusing on particle size distribution, sieving, and classification techniques. This introduction covers why particle size control matters in formulation, dissolution, flow properties, content uniformity, and stability testing. Key topics include sieving methods, wet and dry separation, PSD parameters (D10, D50, D90), efficiency, and regulatory considerations for quality control. Targeted practice with MCQs helps consolidate knowledge, interpret PSD data, select appropriate separation methods, and troubleshoot laboratory issues. This guide is designed to boost exam readiness and practical skills in pharmaceutical size separation. ‘Now let’s test your knowledge with 50 MCQs on this topic.’
Q1. What is the primary objective of size separation in pharmaceutical powder processing?
- To change chemical composition of drug particles
- To obtain a desired particle size distribution for consistent product performance
- To sterilize the powder
- To add moisture to powders
Correct Answer: To obtain a desired particle size distribution for consistent product performance
Q2. Which parameter describes the particle diameter at which 50% of the sample by mass is finer?
- D10
- D90
- D50 (median)
- Span
Correct Answer: D50 (median)
Q3. Which technique is most appropriate for separating coarse granules from fines using a stack of woven meshes?
- Air classification
- Sieving
- Centrifugation
- Filtration
Correct Answer: Sieving
Q4. What does a high span value indicate about a particle size distribution?
- Very narrow size distribution
- Broad size distribution
- All particles are the same size
- Particles are spherical
Correct Answer: Broad size distribution
Q5. Which of the following is NOT an objective of size separation in formulation development?
- Improve dissolution rate
- Enhance flow properties
- Change the drug’s intrinsic solubility
- Ensure content uniformity
Correct Answer: Change the drug’s intrinsic solubility
Q6. In wet sieving, why is liquid used during size separation?
- To dissolve all particles
- To reduce agglomeration and improve passage of fine particles
- To increase static electricity
- To make particles heavier
Correct Answer: To reduce agglomeration and improve passage of fine particles
Q7. Which instrument provides detailed particle size distribution by measuring light scattering?
- Vibratory sieve shaker
- Laser diffraction analyzer
- Optical comparator
- Rotary tablet press
Correct Answer: Laser diffraction analyzer
Q8. Which factor most affects sieving efficiency?
- Tablet color
- Mesh aperture size and particle shape
- Time of day
- Operator’s height
Correct Answer: Mesh aperture size and particle shape
Q9. What is the typical unit for reporting sieve mesh aperture in pharmaceutical sieving?
- Mol/L
- Micrometers (µm)
- Percent w/v
- Kilograms
Correct Answer: Micrometers (µm)
Q10. Air classification separates particles primarily based on which property?
- Electrical conductivity
- Hydrophobicity
- Particle aerodynamic diameter (size and density)
- Magnetic susceptibility
Correct Answer: Particle aerodynamic diameter (size and density)
Q11. Which PSD parameter indicates the smallest size below which 10% of the sample lies?
- D10
- D50
- D90
- Mode
Correct Answer: D10
Q12. Why is particle size control important for inhalation formulations?
- It determines taste
- It influences deposition in the respiratory tract and bioavailability
- It controls tablet shape
- It regulates dissolution in stomach only
Correct Answer: It influences deposition in the respiratory tract and bioavailability
Q13. Which separation method is most suitable for very fine particles (<10 µm) prone to agglomeration?
- Manual sieving
- Wet classification or ultrasonic sieving
- Coarse mesh sieving
- Gravity settling only
Correct Answer: Wet classification or ultrasonic sieving
Q14. What is the main advantage of using laser diffraction for PSD analysis?
- Low accuracy for all sizes
- Rapid measurement over a wide size range with good reproducibility
- Measures chemical impurities
- Requires no sample preparation regardless of material
Correct Answer: Rapid measurement over a wide size range with good reproducibility
Q15. Which of the following affects particle separation by sedimentation?
- Particle density and fluid viscosity
- Tablet coating color
- Ambient noise
- Operator’s mood
Correct Answer: Particle density and fluid viscosity
Q16. In a sieve analysis, what is the reason for using a stack of sieves in descending aperture sizes?
- To mix the sample thoroughly
- To fractionate particles into successive size ranges for PSD determination
- To increase sample temperature
- To sterilize each fraction
Correct Answer: To fractionate particles into successive size ranges for PSD determination
Q17. Which is the correct interpretation if D90 is 200 µm for a batch?
- 90% of particles are larger than 200 µm
- 90% of particles are finer than 200 µm
- Median size is 200 µm
- Only 10% of particles are 200 µm
Correct Answer: 90% of particles are finer than 200 µm
Q18. Which regulatory consideration is related to particle size in pharmaceuticals?
- Particle size has no regulatory relevance
- Particle size can be a critical quality attribute (CQA) affecting safety and efficacy
- Only color must be controlled
- Regulators prohibit sieving
Correct Answer: Particle size can be a critical quality attribute (CQA) affecting safety and efficacy
Q19. What is the effect of reducing particle size on dissolution rate according to the Noyes–Whitney equation?
- Decreases dissolution rate by lowering surface area
- Increases dissolution rate by increasing surface area
- Has no effect
- Makes the drug insoluble
Correct Answer: Increases dissolution rate by increasing surface area
Q20. Which factor can cause blinding of sieve mesh during sieving?
- Particles much smaller than mesh apertures
- Sticky or electrostatically charged particles and moist samples
- High ambient humidity only
- Using too many sieves
Correct Answer: Sticky or electrostatically charged particles and moist samples
Q21. What is ultrasonic sieving primarily used for?
- Heating samples
- Enhancing passage of fine, cohesive particles through mesh by vibration at ultrasonic frequency
- Measuring chemical composition
- Drying the sample
Correct Answer: Enhancing passage of fine, cohesive particles through mesh by vibration at ultrasonic frequency
Q22. Which statement is true about particle shape in size separation?
- Shape does not influence sieving or flow
- Irregular shapes can hinder passage through sieves and reduce flowability
- Only spherical particles are tested
- Shape only affects color
Correct Answer: Irregular shapes can hinder passage through sieves and reduce flowability
Q23. Which measurement gives information about spread of the PSD (polydispersity)?
- D50 only
- Span or standard deviation of the distribution
- Color index
- Tablet hardness
Correct Answer: Span or standard deviation of the distribution
Q24. For granulation operations, why is controlling upper particle size important?
- To avoid segregation and ensure uniform filling and compaction
- To change the API potency
- To increase moisture content
- To change taste
Correct Answer: To avoid segregation and ensure uniform filling and compaction
Q25. Which separation technique is based on centrifugal force to separate particles by size/density?
- Vibratory sieving
- Centrifugation/centrifugal classification
- Magnetic separation
- Manual hand sorting
Correct Answer: Centrifugation/centrifugal classification
Q26. When performing sieve analysis, what is the purpose of tapping or shaking the sieve stack?
- To alter chemical composition
- To aid particle passage through apertures and reduce bridging
- To cool the sample
- To sterilize the sieves
Correct Answer: To aid particle passage through apertures and reduce bridging
Q27. Which phenomenon makes fine particles adhere to sieve mesh and reduce separation efficiency?
- Van der Waals forces and electrostatic attraction
- Gravity only
- Color difference
- Thermal convection
Correct Answer: Van der Waals forces and electrostatic attraction
Q28. Which of the following is a critical quality attribute assessed by size separation in topical suspensions?
- Flavor profile
- Viscosity and particle settling rate/stability
- Tablet disintegration time
- Capsule shell thickness
Correct Answer: Viscosity and particle settling rate/stability
Q29. Which unit operation commonly precedes sieving to break down agglomerates in powders?
- Coating
- Milling or comminution
- Packaging
- Lyophilization
Correct Answer: Milling or comminution
Q30. What is the likely effect on flowability if the particle size distribution becomes narrower and particles are more spherical?
- Flowability decreases dramatically
- Flowability generally improves
- No change
- Material becomes sticky
Correct Answer: Flowability generally improves
Q31. Which method is suitable for continuous industrial-scale size separation of powders by density and size using air flow?
- Batch sieving
- Air classifier
- Manual screening
- Paper filtration
Correct Answer: Air classifier
Q32. In PSD reporting, what does cumulative percent finer plot show?
- Percentage of particles larger than a given size
- Percentage of particles finer than a given size across the size range
- Chemical impurities vs size
- Storage conditions
Correct Answer: Percentage of particles finer than a given size across the size range
Q33. Which pre-treatment can improve sieve analysis results for hygroscopic powders?
- Adding solvents
- Drying to specified moisture content
- Heating beyond decomposition temperature
- Adding acid
Correct Answer: Drying to specified moisture content
Q34. Which of the following is a limitation of wet sieving?
- Cannot separate very fine cohesive powders
- Risk of dissolving or altering materials sensitive to the liquid medium
- Always faster than dry sieving
- Does not reduce agglomeration
Correct Answer: Risk of dissolving or altering materials sensitive to the liquid medium
Q35. What is a common corrective action if sieve blinding occurs during analysis?
- Increase sample moisture
- Use ultrasonic cleaning, change mesh size, or use anti-static measures
- Ignore results
- Paint the sieve
Correct Answer: Use ultrasonic cleaning, change mesh size, or use anti-static measures
Q36. Why is sample size important in sieve analysis?
- Sample size has no impact on results
- Insufficient or excessive sample size can bias PSD results due to stacking or overloading
- Larger samples always give worse results
- Only color matters
Correct Answer: Insufficient or excessive sample size can bias PSD results due to stacking or overloading
Q37. Which PSD technique provides morphological (shape) information in addition to size?
- Laser diffraction only
- Optical image analysis or dynamic image analysis
- Standard sieve analysis only
- Viscometry
Correct Answer: Optical image analysis or dynamic image analysis
Q38. Which statement best summarizes the role of size separation in bioavailability of poorly soluble drugs?
- Size separation always reduces bioavailability
- Reducing particle size can enhance dissolution and potentially improve bioavailability of poorly soluble drugs
- Only temperature affects bioavailability
- Particle size is unrelated to dissolution
Correct Answer: Reducing particle size can enhance dissolution and potentially improve bioavailability of poorly soluble drugs
Q39. What is the effect of cohesive forces on powder sieving and handling?
- Cohesion improves sieving efficiency
- Cohesive forces cause agglomeration, reducing sieving efficiency and flowability
- Cohesion only affects color
- Cohesion makes powders magnetic
Correct Answer: Cohesive forces cause agglomeration, reducing sieving efficiency and flowability
Q40. Which control parameter should be validated for a sieve shaker used in QC testing?
- Vibration amplitude/frequency and test time
- Operator’s favorite music
- Room color
- Sample flavor
Correct Answer: Vibration amplitude/frequency and test time
Q41. For a suspension, why is particle size distribution critical to stability?
- Smaller particles always sediment faster
- PSD affects sedimentation rate, redispersibility, and visual appearance; wider PSD may lead to caking
- Only viscosity matters
- PSD controls chemical degradation only
Correct Answer: PSD affects sedimentation rate, redispersibility, and visual appearance; wider PSD may lead to caking
Q42. Which technique separates particles by allowing smaller ones to pass through a porous medium while retaining larger ones?
- Sieving/screening
- Electrophoresis
- X-ray diffraction
- Lyophilization
Correct Answer: Sieving/screening
Q43. What is a common QC acceptance criterion related to particle size for tablet granules?
- All granules must be 1 mm exactly
- Specified percent by weight must fall within defined sieve ranges to ensure uniform filling and compaction
- Only the API content matters
- Color matching is sufficient
Correct Answer: Specified percent by weight must fall within defined sieve ranges to ensure uniform filling and compaction
Q44. Which property is NOT directly determined by particle size?
- Surface area
- Dissolution rate
- Intrinsic chemical structure
- Flowability
Correct Answer: Intrinsic chemical structure
Q45. Which corrective measure can reduce static charging and improve sieving of fine powders?
- Increase humidity, use antistatic agents or grounding
- Freeze the powder
- Paint the sieve
- Remove all vibration
Correct Answer: Increase humidity, use antistatic agents or grounding
Q46. During particle size analysis by laser diffraction, which assumption may introduce error?
- Particles are transparent
- Assuming particles are spherical when they are irregular
- Laser light is monochromatic
- Detector is calibrated
Correct Answer: Assuming particles are spherical when they are irregular
Q47. Which analytical value would indicate a formulation has an excess of fines that may cause dusting and segregation?
- Low D10 value with high percent below a small size threshold
- High D90 only
- Zero percent fines
- Perfectly uniform particles
Correct Answer: Low D10 value with high percent below a small size threshold
Q48. For nanoparticle formulations, what specialized separation or characterization methods are commonly used?
- Standard hand sieves
- Ultracentrifugation, dynamic light scattering (DLS), and electron microscopy
- Tablet hardness tester
- Colorimeter only
Correct Answer: Ultracentrifugation, dynamic light scattering (DLS), and electron microscopy
Q49. How does particle density influence settling velocity in a suspension?
- Higher particle density generally increases settling velocity according to Stoke’s law (if spherical and laminar conditions apply)
- Density has no effect
- Lower density always increases settling
- Only particle color matters
Correct Answer: Higher particle density generally increases settling velocity according to Stoke’s law (if spherical and laminar conditions apply)
Q50. Which practice helps ensure representative sampling for PSD analysis?
- Taking a single small scoop from the top of a lot
- Using randomized, stratified samples and proper sample splitting to account for heterogeneity
- Only sampling after sieving
- Sampling only the largest particles
Correct Answer: Using randomized, stratified samples and proper sample splitting to account for heterogeneity

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