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

Author

  • G S Sachin
    : Author

    G S Sachin is a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. He holds a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research and creates clear, accurate educational content on pharmacology, drug mechanisms of action, pharmacist learning, and GPAT exam preparation.

    Mail- Sachin@pharmacyfreak.com

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