In-process and final quality control tests for hard gelatin capsules MCQs With Answer

Hard gelatin capsules are a widely used oral dosage form; understanding in-process and final quality control tests for hard gelatin capsules is essential for B.Pharm students. This introduction covers key pharmaceutical quality control topics such as in-process checks (capsule shell inspection, fill weight control, weight variation, visual defects, moisture/Loss on Drying, microbial monitoring) and final QC tests (disintegration, dissolution, content uniformity, assay by HPLC, residual solvents by GC, microbial limits, stability). Emphasis is placed on test purpose, methods, acceptance criteria, and regulatory compliance (USP/BP/ICH). Mastery of these QC tests ensures capsule integrity, potency, safety, and batch release. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of in-process quality control tests during hard gelatin capsule manufacturing?

• To verify final marketing claims
• To detect and correct process deviations early
• To perform stability testing after packaging
• To conduct full clinical evaluation

Correct Answer: To detect and correct process deviations early

Q2. Which of the following is a common in-process test for hard gelatin capsules?

• Dissolution testing
• Fill weight variation
• Long-term stability study
• Endotoxin test

Correct Answer: Fill weight variation

Q3. Which final quality control test measures the rate and extent of drug release from a capsule?

• Disintegration test
• Dissolution test
• Loss on drying
• Microbial limit test

Correct Answer: Dissolution test

Q4. Which instrument is typically used to determine whether a hard gelatin capsule disintegrates within a specified time?

• Dissolution apparatus
• Disintegration tester
• HPLC system
• Gas chromatograph

Correct Answer: Disintegration tester

Q5. For most immediate‑release hard gelatin capsules, what is a common pharmacopoeial disintegration time limit?

• Less than 5 minutes
• Within 30 minutes
• Within 8 hours
• No disintegration specification

Correct Answer: Within 30 minutes

Q6. What does the content uniformity test determine for capsules?

• The capsule shell tensile strength
• The uniform distribution of active ingredient among units
• The color consistency of the shell
• The rate of moisture uptake from packaging

Correct Answer: The uniform distribution of active ingredient among units

Q7. Which analytical technique is commonly used for accurate potency (assay) determination of the drug in capsules?

• UV-visible visual inspection
• High-performance liquid chromatography (HPLC)
• Dissolution testing
• Disintegration tester

Correct Answer: High-performance liquid chromatography (HPLC)

Q8. Which test is used to measure moisture content of capsule shells or fill material?

• Loss on drying (LOD)
• Friability test
• Disintegration test
• Endotoxin test

Correct Answer: Loss on drying (LOD)

Q9. Visual inspection of hard gelatin capsules during in-process control primarily checks for which defects?

• Assay and impurities
• Cracks, splits, cap/body mismatch and contamination
• Residual solvents and heavy metals
• Dissolution profile differences

Correct Answer: Cracks, splits, cap/body mismatch and contamination

Q10. Which test ensures that the final capsule batch meets microbiological safety requirements?

• Uniformity of dosage units
• Microbial limit test
• Weight variation test
• Disintegration test

Correct Answer: Microbial limit test

Q11. When is weight variation used instead of content uniformity according to general pharmacopeial guidance?

• When active ingredient is highly potent (<1 mg)
• When API content >25 mg or >25% of capsule mass
• For modified‑release capsules only
• Weight variation is never used for capsules

Correct Answer: When API content >25 mg or >25% of capsule mass

Q12. Gelatin cross‑linking in capsule shells primarily affects which quality attribute?

• Color uniformity
• Disintegration and dissolution (slower or incomplete)
• Assay by HPLC
• Microbial counts

Correct Answer: Disintegration and dissolution (slower or incomplete)

Q13. How is fill weight of hard gelatin capsules most accurately determined during in‑process control?

• By measuring dissolution rate
• By weighing filled capsules and subtracting average empty shell weight
• By performing a visual volume check only
• By measuring disintegration time

Correct Answer: By weighing filled capsules and subtracting average empty shell weight

Q14. Which of the following tests is primarily associated with tablets rather than hard gelatin capsules?

• Dissolution test
• Friability test
• Disintegration test
• Uniformity of dosage units

Correct Answer: Friability test

Q15. Which environmental parameters are critical to control during capsule manufacturing and in-process testing?

• Light intensity only
• Temperature and relative humidity
• Magnetic field strength
• Packaging color

Correct Answer: Temperature and relative humidity

Q16. What is the purpose of banding or sealing between capsule cap and body as an in-process operation?

• To change the dissolution medium
• To improve cap‑body mechanical integrity and reduce leakage
• To increase microbial contamination
• To alter the active pharmaceutical ingredient

Correct Answer: To improve cap‑body mechanical integrity and reduce leakage

Q17. Which test specifically detects pyrogens or bacterial endotoxins relevant for parenteral products but sometimes considered in excipient testing?

• Disintegration test
• Bacterial endotoxin test (BET)
• Loss on drying
• Weight variation

Correct Answer: Bacterial endotoxin test (BET)

Q18. Which USP dissolution apparatus is most commonly used for testing hard gelatin capsules?

• Apparatus 4 (flow‑through)
• Apparatus 2 (paddle)
• Apparatus 5 (paddle over disk)
• Apparatus 6 (reciprocating cylinder)

Correct Answer: Apparatus 2 (paddle)

Q19. Which medium is typically used for dissolution/disintegration testing that simulates stomach conditions?

• Simulated gastric fluid (0.1 N HCl)
• Chloroform
• Pure ethanol
• Distilled water at 80°C

Correct Answer: Simulated gastric fluid (0.1 N HCl)

Q20. What does the dissolution test profile help determine besides percent drug released?

• Packaging size
• Release kinetics and comparability between batches or formulations
• Color stability of the shell
• Visual appearance of the capsule

Correct Answer: Release kinetics and comparability between batches or formulations

Q21. Which in-process control is most important to monitor to maintain consistent drug content per capsule?

• Airflow in the packaging room
• Fill weight and blend uniformity
• Label printing color
• Storage shelf location

Correct Answer: Fill weight and blend uniformity

Q22. Which method is typically used to quantify residual organic solvents in capsule formulations?

• High-performance thin-layer chromatography
• Gas chromatography (GC)
• Disintegration testing
• Loss on drying

Correct Answer: Gas chromatography (GC)

Q23. Which test most directly assesses the chemical purity and related substances in a capsule batch?

• Visual inspection
• Assay and related substances by HPLC
• Disintegration test
• Weight variation

Correct Answer: Assay and related substances by HPLC

Q24. Dye penetration or vacuum leak tests for capsules are primarily used to detect what defect?

• Incorrect potency
• Cap‑body seal failures and leakage
• Poor dissolution only
• High microbial counts

Correct Answer: Cap‑body seal failures and leakage

Q25. Which packaging quality test is important to prevent moisture ingress that can affect gelatin capsules?

• Moisture vapor transmission rate (MVTR) of the container
• Disintegration testing of unopened capsules
• Endotoxin testing of the capsule shell
• Assay of labeled claim

Correct Answer: Moisture vapor transmission rate (MVTR) of the container

Q26. What is the typical consequence of excessive moisture in hard gelatin capsules?

• Improved dissolution always
• Capsule softening, sticking, and microbial growth
• Reduced assay by chemical decomposition only at −20°C
• No effect on quality

Correct Answer: Capsule softening, sticking, and microbial growth

Q27. During final QC, what is the role of stability testing for capsules?

• To evaluate long‑term changes in potency, dissolution, and appearance under defined conditions
• To measure initial fill weight only
• To assess packing line speed
• To detect visual defects on day 0 only

Correct Answer: To evaluate long‑term changes in potency, dissolution, and appearance under defined conditions

Q28. Which analytical technique is commonly used to quantify trace heavy metals in excipients or capsules?

• Atomic absorption spectroscopy (AAS)
• Disintegration testing
• Visual inspection
• Loss on drying

Correct Answer: Atomic absorption spectroscopy (AAS)

Q29. Which of the following final QC specifications is expressed as “Q” in dissolution testing?

• The pH of the dissolution medium
• The percent label claim that must be dissolved at a specified time
• The fill weight accuracy
• The microbial limit threshold

Correct Answer: The percent label claim that must be dissolved at a specified time

Q30. In a routine batch release, which combination of tests is most commonly required for hard gelatin capsules?

• Assay, dissolution or disintegration, weight variation/content uniformity, and microbial limits
• Only visual inspection
• Only residual solvent testing
• Only pyrogen testing

Correct Answer: Assay, dissolution or disintegration, weight variation/content uniformity, and microbial limits

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