Analysis of finished pharmaceutical products MCQs With Answer

Introduction:

Analysis of finished pharmaceutical products MCQs With Answer is a focused quiz resource designed for M.Pharm students specializing in Quality Control and Quality Assurance. This collection emphasizes critical analytical tests, regulatory expectations, and interpretation of results common to finished product release testing. Questions cover physicochemical assays, microbiological examinations, stability considerations, analytical techniques (HPLC, GC, IR, LAL), sampling plans, and method validation aspects frequently encountered in industry and regulatory inspections. The MCQs aim to reinforce conceptual understanding, improve practical decision-making skills, and prepare students for examinations and real-world QC/QA responsibilities by blending theory with application-based scenarios.

Q1. What is the primary objective of finished pharmaceutical product analysis?

• To develop new manufacturing processes
• To ensure compliance with predefined specifications and release criteria
• To determine raw material impurity profiles only
• To replace in-process quality controls

Correct Answer: To ensure compliance with predefined specifications and release criteria

Q2. Which test is specifically designed to measure the time taken for a tablet to break down into particles?

• Dissolution test
• Disintegration test
• Friability test
• Assay by HPLC

Correct Answer: Disintegration test

Q3. Content uniformity testing is primarily intended to assess which of the following?

• Uniformity of tablet weight within a batch
• Assay of individual dosage units for uniform potency
• Total impurity level in the batch
• Moisture content of the batch

Correct Answer: Assay of individual dosage units for uniform potency

Q4. Which parameter is directly evaluated by dissolution testing of oral solid dosage forms?

• Microbial contamination
• Rate and extent of API release from the dosage form
• Tablet disintegration only
• Residual solvent content

Correct Answer: Rate and extent of API release from the dosage form

Q5. Which analytical technique is preferred for quantifying residual volatile organic solvents in a finished product?

• High performance liquid chromatography (HPLC)
• Infrared spectroscopy (IR)
• Gas chromatography (GC)
• UV-Visible spectrophotometry

Correct Answer: Gas chromatography (GC)

Q6. Which modern elemental technique is most suitable for determining trace heavy metal impurities in finished pharmaceuticals?

• Thin layer chromatography (TLC)
• Inductively coupled plasma mass spectrometry (ICP-MS)
• Polarimetry
• Nuclear magnetic resonance (NMR)

Correct Answer: Inductively coupled plasma mass spectrometry (ICP-MS)

Q7. Which of the following tests detects viable microbial contamination in non-sterile finished products?

• Assay by titration
• Microbial limit tests (TAMC/TYMC)
• Disintegration test
• Dissolution profiling

Correct Answer: Microbial limit tests (TAMC/TYMC)

Q8. Loss on drying (LOD) or moisture content determination is primarily used to assess what attribute of a finished product?

• Chemical purity of the API
• Residual solvent classification
• Water/moisture content
• Microbial endotoxin level

Correct Answer: Water/moisture content

Q9. The friability test on tablets is intended to assess which property?

• Chemical stability under light exposure
• Tablet mechanical resistance to abrasion and chipping
• Drug dissolution rate in gastric fluid
• Residual solvents after drying

Correct Answer: Tablet mechanical resistance to abrasion and chipping

Q10. In method validation, which parameter describes how close measured values are to the true value?

• Precision
• Specificity
• Accuracy
• Robustness

Correct Answer: Accuracy

Q11. According to ICH guidelines, which conditions are typically used for accelerated stability testing?

• 5°C ± 3°C and 30% RH
• 25°C ± 2°C and 60% RH ± 5%
• 40°C ± 2°C and 75% RH ± 5%
• 0°C and dry conditions

Correct Answer: 40°C ± 2°C and 75% RH ± 5%

Q12. Which common product defect can be identified during visual inspection of tablets?

• Incorrect assay by HPLC
• Cracking, chipping or surface mottling
• Residual solvent concentration
• Endotoxin levels

Correct Answer: Cracking, chipping or surface mottling

Q13. Under ICH Q3C residual solvent classification, which class contains solvents that should be avoided because of known carcinogenicity?

• Class 3 (low toxic potential)
• Class 2 (to be limited)
• Class 1 (solvents to be avoided)
• Class 4 (non-relevant)

Correct Answer: Class 1 (solvents to be avoided)

Q14. In-vitro–in-vivo correlation (IVIVC) is most relevant for which type of dosage forms?

• Immediate-release oral solutions
• Topical creams with no systemic absorption
• Modified or extended-release oral dosage forms
• Parenteral sterile injections

Correct Answer: Modified or extended-release oral dosage forms

Q15. Which pharmacopeial identification technique is commonly used to confirm API identity based on characteristic absorption bands?

• Gas chromatography
• Infrared (IR) spectroscopy
• Loss on drying
• Friability testing

Correct Answer: Infrared (IR) spectroscopy

Q16. Which test is used to detect bacterial endotoxins in parenteral products?

• Sterility test by membrane filtration
• Limulus Amebocyte Lysate (LAL) test
• Total aerobic microbial count (TAMC)
• Disintegration test

Correct Answer: Limulus Amebocyte Lysate (LAL) test

Q17. The weight variation test for tablets is applied primarily when which condition applies?

• Assay of individual units is required for content uniformity
• Assay of individual units is not suitable and the product meets monograph criteria
• Product is a sterile injectable
• Residual solvents are above acceptance limits

Correct Answer: Assay of individual units is not suitable and the product meets monograph criteria

Q18. What is the primary objective of photostability testing of finished products (ICH Q1B)?

• To evaluate resistance to microbial contamination under light
• To determine susceptibility of the product to degradation upon exposure to light
• To assess tablet hardness after sun exposure
• To quantify residual solvents after light exposure

Correct Answer: To determine susceptibility of the product to degradation upon exposure to light

Q19. What does the statistical term AQL stand for in the context of finished product sampling?

• Analytical Quantitative Limit
• Acceptable Quality Level
• Assay Qualification Limit
• Average Quality Limit

Correct Answer: Acceptable Quality Level

Q20. What is the main purpose of a representative sampling plan for finished pharmaceutical products?

• To reduce the number of quality tests performed
• To ensure collected samples accurately represent the whole batch for quality assessment
• To validate manufacturing equipment
• To control marketing release dates

Correct Answer: To ensure collected samples accurately represent the whole batch for quality assessment

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