Evaluation of liquid orals official in pharmacopoeia MCQs With Answer introduces B. Pharm students to essential pharmacopoeial quality control of liquid dosage forms. This concise guide covers evaluation of liquid orals, including official tests for identification, assay (HPLC/titration), pH, viscosity, specific gravity, weight per mL, particulate matter, preservative efficacy test, microbial limits (TAMC/ TYMC), uniformity, stability, container-closure integrity, and dissolution for suspensions. Emphasis is placed on pharmacopeial monographs (USP/BP/IP), acceptance criteria, sampling, and analytical techniques used in routine QC and release testing. Practical keywords: pharmacopoeial tests, liquid orals evaluation, quality control, preservative testing, microbial limits, assay, viscosity. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which official test in pharmacopoeia primarily assesses antimicrobial protection of multi-dose liquid oral formulations?
- Preservative Efficacy Test (PET)
- Total Aerobic Microbial Count (TAMC)
- Sterility Test
- Particulate Matter Test
Correct Answer: Preservative Efficacy Test (PET)
Q2. What is the typical pharmacopoeial acceptance criterion measured for syrups to ensure consistency of density?
- Viscosity value in cP
- Weight per mL
- pH range
- Refractive index only
Correct Answer: Weight per mL
Q3. For an oral suspension, which parameter is crucial to evaluate re-dispersibility after storage?
- Assay by HPLC
- Sedimentation volume and ease of re-dispersion
- Preservative concentration
- Specific gravity of continuous phase
Correct Answer: Sedimentation volume and ease of re-dispersion
Q4. Which pharmacopoeial test ensures the correct amount of active pharmaceutical ingredient in a liquid oral product?
- Identification test
- Assay (e.g., titration or HPLC)
- pH measurement
- Particulate matter counting
Correct Answer: Assay (e.g., titration or HPLC)
Q5. Which instrument is commonly specified in pharmacopeia for measuring viscosity of liquid orals?
- UV-Vis spectrophotometer
- Brookfield viscometer
- Gas chromatograph
- Digital pH meter
Correct Answer: Brookfield viscometer
Q6. Which microbial limit is typically assessed to ensure safety of non-sterile liquid orals?
- Total Aerobic Microbial Count (TAMC)
- Endotoxin limit
- Sterility
- Mycoplasma absence
Correct Answer: Total Aerobic Microbial Count (TAMC)
Q7. What does the pharmacopoeial “identification” test confirm for a liquid oral?
- Identity of the active ingredient
- pH stability only
- Viscosity profile
- Container-closure integrity
Correct Answer: Identity of the active ingredient
Q8. Which test is most relevant for syrups to detect insoluble particulates that may pose quality issues?
- Particulate matter test (visual and light obscuration)
- Assay by titration
- Preservative Efficacy Test
- Refractive index only
Correct Answer: Particulate matter test (visual and light obscuration)
Q9. In pharmacopoeial monographs, which parameter often has a specified acceptance range for liquid orals to ensure palatability and stability?
- pH range
- Color only
- Packaging weight
- Ambient humidity
Correct Answer: pH range
Q10. Which official test would detect microbial contamination by specific objectionable organisms such as Escherichia coli in liquid orals?
- Antimicrobial preservative content assay
- Test for specified microorganisms (absence of E. coli)
- Sedimentation test
- Viscosity profiling
Correct Answer: Test for specified microorganisms (absence of E. coli)
Q11. For an oral suspension, which particle characteristic is commonly monitored according to pharmacopoeial guidance?
- Particle size distribution
- Boiling point
- Refractive index only
- Volatility
Correct Answer: Particle size distribution
Q12. Which pharmacopoeial parameter assesses solute concentration in sugar-based syrups indirectly via refractive index or density?
- Viscosity alone
- Specific gravity or refractive index
- Particulate matter count
- Assay by HPLC only
Correct Answer: Specific gravity or refractive index
Q13. What is the purpose of container-closure integrity testing for liquid orals as per pharmacopeial recommendations?
- To measure assay of API
- To ensure no microbial ingress and maintain product stability
- To determine viscosity
- To quantify sugar content
Correct Answer: To ensure no microbial ingress and maintain product stability
Q14. Which test is specifically required for sterile liquid orals but not for non-sterile preparations?
- Sterility test
- Preservative Efficacy Test
- Total Yeast and Mold Count (TYMC)
- pH measurement
Correct Answer: Sterility test
Q15. Which pharmacopoeial test assesses the leaching of chemicals from packaging into liquid orals?
- Extractables and leachables study
- Particulate matter test
- Viscosity test
- Assay only
Correct Answer: Extractables and leachables study
Q16. For liquid orals, which stability study condition is commonly recommended in pharmacopeial testing to predict shelf life?
- Long-term real-time only
- Accelerated stability at elevated temperature and humidity
- Freeze-thaw cycling only
- Viscosity at low shear only
Correct Answer: Accelerated stability at elevated temperature and humidity
Q17. Which analytical technique is most commonly cited in pharmacopoeia for quantitative assay of many drug substances in liquid orals?
- High-performance liquid chromatography (HPLC)
- Gravimetric loss on drying
- Refractive index only
- Thermogravimetric analysis
Correct Answer: High-performance liquid chromatography (HPLC)
Q18. What does the term “official” in a pharmacopoeial monograph mean for a liquid oral product?
- It is the only marketed brand
- The standards and tests are legally recognized for quality control
- It is exempt from testing
- It denotes taste approval
Correct Answer: The standards and tests are legally recognized for quality control
Q19. Which pharmacopeial test evaluates particulate reduction during filtration of liquid orals?
- Filterability and clarity tests
- pH range determination
- Assay reproducibility
- Viscosity under high shear
Correct Answer: Filterability and clarity tests
Q20. Which test helps determine the ionic strength and buffer capacity of an oral solution as per pharmacopeial methods?
- pH measurement and titration of buffering capacity
- Particle size analysis
- Endotoxin assay
- Refractive index only
Correct Answer: pH measurement and titration of buffering capacity
Q21. In preservative efficacy testing, which outcome indicates acceptable preservative activity?
- Increase in microbial count over time
- Specified log reduction of challenge organisms within defined time points
- No change in pH
- Complete sterility at time zero only
Correct Answer: Specified log reduction of challenge organisms within defined time points
Q22. Which heavy metal test is commonly included in pharmacopoeial specifications for liquid orals?
- Lead limit test (heavy metals)
- Mercury only
- Chromatographic impurity profiling only
- Water hardness test
Correct Answer: Lead limit test (heavy metals)
Q23. Which dissolution-related test may be relevant for certain oral suspensions or emulsions in pharmacopoeial evaluation?
- Dissolution or release testing to assess release rate of API
- Sedimentation volume alone
- Refractive index only
- Viscosity at infinite shear
Correct Answer: Dissolution or release testing to assess release rate of API
Q24. What is the primary purpose of measuring pH in liquid orals according to pharmacopoeial guidelines?
- To determine particulate count
- To ensure chemical stability, solubility and preservative performance
- To measure API potency directly
- To calculate specific gravity
Correct Answer: To ensure chemical stability, solubility and preservative performance
Q25. Which sampling principle is emphasized by pharmacopoeia for representative testing of liquid oral batches?
- Random and statistically justified sampling across the batch
- Sampling only from the first filled container
- Sampling after destroy-test only
- Sampling only the visually best containers
Correct Answer: Random and statistically justified sampling across the batch
Q26. Which test detects insoluble matter visually in clear liquid orals as per pharmacopeial methods?
- Visual inspection against light background
- pH titration
- Viscosity profiling
- Sterility test
Correct Answer: Visual inspection against light background
Q27. For liquid orals, what is the significance of measuring refractive index in pharmacopeial tests?
- To assess concentration of sugar or solids and detect adulteration
- To measure microbial count
- To quantify preservatives directly
- To determine viscosity only
Correct Answer: To assess concentration of sugar or solids and detect adulteration
Q28. Which pharmacopoeial documentation must accompany official test methods for liquid orals in a QC lab?
- Unvalidated in-house notes only
- Validated analytical methods with SOPs and acceptance criteria
- Only supplier certificates
- Only batch manufacturing records
Correct Answer: Validated analytical methods with SOPs and acceptance criteria
Q29. Which approach is recommended by pharmacopoeia to verify in-use stability of multi-dose liquid orals after opening?
- In-use stability study simulating recommended dosing and storage
- Single-point assay at manufacture only
- Only a consumer survey
- Visual check at release only
Correct Answer: In-use stability study simulating recommended dosing and storage
Q30. Which parameter is essential to assess for flavored pediatric syrups in pharmacopoeial evaluation to ensure dose uniformity and safety?
- Uniformity of content per mL and preservative efficacy
- Only color matching
- Only container printing quality
- Only sugar content for taste
Correct Answer: Uniformity of content per mL and preservative efficacy
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
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