Quality control tests of tablets MCQs With Answer

Quality control tests of tablets MCQs With Answer help B.Pharm students build a strong foundation in tablet evaluation, analytical procedures, and regulatory expectations. This focused set emphasizes key keywords: dissolution testing, disintegration, hardness, friability, weight variation, content uniformity, assay (HPLC/UV), stability testing, dissolution media, pharmacopeial limits, and similarity factor (f2). Questions are designed to deepen understanding of instrumentation (paddle/basket apparatus, friabilators, hardness testers), sampling strategies, analytical methods, and interpretation of QC data. These MCQs bridge theory and practical QC practice to prepare you for exams and lab decision-making. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which quality control test measures the time taken for a tablet to break down into particles suitable for dissolution?

  • Hardness test
  • Disintegration test
  • Dissolution test
  • Friability test

Correct Answer: Disintegration test

Q2. Which apparatus is designated as USP Apparatus II for dissolution testing?

  • Basket apparatus
  • Paddle apparatus
  • Flow-through cell
  • Reciprocating cylinder

Correct Answer: Paddle apparatus

Q3. Which QC test evaluates mechanical strength of a tablet by measuring the force required to crush it?

  • Friability
  • Hardness
  • Weight variation
  • Content uniformity

Correct Answer: Hardness

Q4. Which instrument is commonly used to assess tablet friability?

  • Roche friabilator
  • UV-visible spectrophotometer
  • Disintegration tester
  • HPLC system

Correct Answer: Roche friabilator

Q5. What is the main objective of a dissolution test in tablet QC?

  • Measure moisture content
  • Determine tablet thickness
  • Evaluate rate and extent of drug release
  • Assess microbial contamination

Correct Answer: Evaluate rate and extent of drug release

Q6. Which test ensures each tablet contains the intended drug amount within specified limits for low-dose potent drugs?

  • Weight variation
  • Assay of bulk powder
  • Content uniformity
  • Friability

Correct Answer: Content uniformity

Q7. Which analytical technique provides the highest specificity for assay of a drug substance in tablet QC?

  • UV-visible spectrophotometry
  • Thin-layer chromatography
  • High-performance liquid chromatography (HPLC)
  • Colorimetric test

Correct Answer: High-performance liquid chromatography (HPLC)

Q8. Which test detects weight loss due to abrasion or handling and is reported as percentage weight loss?

  • Hardness test
  • Friability test
  • Disintegration test
  • Assay

Correct Answer: Friability test

Q9. Which of the following is a common dissolution medium pH used to simulate intestinal fluid?

  • pH 1.2
  • pH 4.5
  • pH 6.8
  • pH 9.0

Correct Answer: pH 6.8

Q10. Which QC test directly quantifies the total active pharmaceutical ingredient in a tablet?

  • Thickness measurement
  • Assay
  • Disintegration
  • Friability

Correct Answer: Assay

Q11. Which phenomenon in tablets is most likely to be revealed by a high friability value?

  • Excessive hardness
  • Poor mechanical integrity (chipping, abrasion)
  • Incorrect potency
  • Incorrect dissolution medium

Correct Answer: Poor mechanical integrity (chipping, abrasion)

Q12. Which factor most directly influences dissolution rate of a tablet?

  • Tablet color
  • Particle size of active ingredient
  • Labeling information
  • Ambient room lighting

Correct Answer: Particle size of active ingredient

Q13. The similarity factor f2 is used to compare dissolution profiles. An f2 value of 50 or greater generally indicates what?

  • Profiles are dissimilar
  • Profiles are identical in every point
  • Profiles are similar
  • Profiles are unacceptable

Correct Answer: Profiles are similar

Q14. Which QC test uses a basket-rack assembly as per pharmacopeial methods?

  • Disintegration test
  • Dissolution test using USP I
  • Hardness test
  • Friability test

Correct Answer: Dissolution test using USP I

Q15. Which of the following assesses uniformity of mass across individual tablets in a batch?

  • Content uniformity
  • Weight variation test
  • Assay by HPLC
  • Moisture content

Correct Answer: Weight variation test

Q16. Which sample analysis technique is commonly used to quantify drug dissolved during a dissolution test?

  • Gravimetric analysis
  • UV-visible spectrophotometry or HPLC
  • Microscopy
  • pH meter

Correct Answer: UV-visible spectrophotometry or HPLC

Q17. Which QC parameter assesses moisture present in tablets and can affect stability?

  • Hardness
  • Loss on drying
  • Friability
  • Disintegration

Correct Answer: Loss on drying

Q18. Enteric-coated tablets are designed to remain intact in which environment?

  • High pH intestinal fluid
  • Low pH gastric fluid
  • Neutral pH blood plasma
  • High ionic strength media

Correct Answer: Low pH gastric fluid

Q19. Which QC test would best detect content non-uniformity caused by poor mixing of active ingredient?

  • Thickness measurement
  • Content uniformity test
  • Friability test
  • Disintegration test

Correct Answer: Content uniformity test

Q20. Microbial limit tests for tablets are primarily intended to assess what?

  • Chemical potency
  • Microbial contamination levels in non-sterile products
  • Tablet color uniformity
  • Hardness distribution

Correct Answer: Microbial contamination levels in non-sterile products

Q21. Which factor is NOT typically evaluated during routine tablet QC?

  • Dissolution
  • Assay
  • Content uniformity
  • Patient adherence monitoring

Correct Answer: Patient adherence monitoring

Q22. Which method is most suitable to separate and quantify degradation products and impurities in a tablet assay?

  • Thin-layer chromatography (qualitative)
  • HPLC with appropriate detection
  • Visual inspection
  • Tablet thickness measurement

Correct Answer: HPLC with appropriate detection

Q23. Which QC attribute is most directly affected by insufficient lubrication during tablet compression?

  • Content uniformity
  • Sticking and picking defects
  • Assay potency
  • Dissolution medium pH

Correct Answer: Sticking and picking defects

Q24. In dissolution testing, which of these is a common standard volume used for paddle apparatus?

  • 100 mL
  • 500 mL
  • 900 mL
  • 5000 mL

Correct Answer: 900 mL

Q25. Which test outcome would suggest that a tablet batch may have stability problems under accelerated conditions?

  • Unchanged dissolution and assay
  • Significant assay loss and increased impurities
  • Improved hardness over time
  • Reduced friability without potency change

Correct Answer: Significant assay loss and increased impurities

Q26. What is the primary purpose of visual inspection in tablet QC?

  • Quantify active ingredient
  • Detect physical defects like chips, cracks, discoloration
  • Measure dissolution rate
  • Determine moisture content

Correct Answer: Detect physical defects like chips, cracks, discoloration

Q27. Which property of excipients can significantly influence tablet dissolution profile?

  • Excipient color
  • Excipient solubility and binder level
  • Coating machine brand
  • Label font size

Correct Answer: Excipient solubility and binder level

Q28. Which technique is commonly used to prepare dissolution samples for HPLC analysis?

  • Direct plating of tablets
  • Filtration and dilution into mobile phase
  • Lyophilization of dissolution medium
  • Microscopy of undissolved residue

Correct Answer: Filtration and dilution into mobile phase

Q29. A tablet shows high variability in individual unit assay results; which of the following is the most likely cause?

  • Accurate HPLC calibration
  • Poor content mixing or segregation during manufacturing
  • Proper granulation process
  • Uniform tablet coating

Correct Answer: Poor content mixing or segregation during manufacturing

Q30. Which QC test would you perform to confirm that coated tablets will not release drug in stomach but release in intestine?

  • Hardness test
  • Enteric coating dissolution test at sequential pH
  • Friability test
  • Weight variation

Correct Answer: Enteric coating dissolution test at sequential pH

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