Pharmacopoeia are authoritative compendia of standards that define quality, identity, purity and strength of drugs and excipients, forming the backbone of pharmaceutical analysis. For B.Pharm students, understanding pharmacopoeial monographs, official assays, identification tests, limits for impurities, reference standards (USP, BP, IP) and analytical methods (HPLC, GC, titration, dissolution) is essential for quality control and regulatory compliance. Pharmacopoeia guide formulation testing, stability assessment, sterility and potency evaluation, ensuring patient safety and product efficacy. Mastery of these concepts equips future pharmacists to interpret monographs, validate methods and apply standards in the lab and industry. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary purpose of a pharmacopoeia?
- To provide marketing guidelines for pharmaceutical companies
- To list all possible adverse drug reactions
- To set official standards for identity, purity and strength of medicines
- To publish clinical trial data
Correct Answer: To set official standards for identity, purity and strength of medicines
Q2. Which of the following is an example of a national pharmacopoeia?
- International Conference on Harmonisation (ICH)
- United States Pharmacopeia (USP)
- World Health Organization Model List
- European Medicines Agency guidelines
Correct Answer: United States Pharmacopeia (USP)
Q3. A pharmacopoeial monograph typically includes which of these sections?
- Marketing strategy and cost analysis
- Identification, assay, and impurity limits
- Patient counseling scripts
- Clinical efficacy comparisons
Correct Answer: Identification, assay, and impurity limits
Q4. Which analytical technique is commonly specified in pharmacopoeial assays for quantification of drugs?
- Thin layer chromatography for potency measurement
- High-performance liquid chromatography (HPLC)
- Light microscopy
- Paper chromatography for all assays
Correct Answer: High-performance liquid chromatography (HPLC)
Q5. What is a pharmacopoeial reference standard?
- A guideline for clinical use of a drug
- An official chemical substance used for assay calibration
- A marketing sample used for stability studies
- An internal company control not recognized by regulators
Correct Answer: An official chemical substance used for assay calibration
Q6. Which term describes impurities structurally related to the drug substance?
- Foreign contaminants
- Related substances
- Excipients
- Placebos
Correct Answer: Related substances
Q7. What legal status do pharmacopoeial standards typically have in many countries?
- Advisory only, never enforceable
- Scientific suggestions without legal effect
- Statutory or regulatory force when referenced in law
- Confidential internal documents for manufacturers
Correct Answer: Statutory or regulatory force when referenced in law
Q8. Which test in a monograph confirms the chemical identity of a drug?
- Assay only
- Identification tests such as IR or specific chemical reactions
- Dissolution testing only
- Uniformity of dosage units
Correct Answer: Identification tests such as IR or specific chemical reactions
Q9. A titrimetric assay in a pharmacopoeial monograph is primarily used to determine:
- Microbial contamination
- Particle size distribution
- Drug content or potency
- Packaging integrity
Correct Answer: Drug content or potency
Q10. Which pharmacopoeial test evaluates the rate and extent of drug release from a dosage form?
- Dissolution testing
- Sterility testing
- Titratable acidity
- Assay for moisture content
Correct Answer: Dissolution testing
Q11. What is the purpose of limit tests in pharmacopoeial analysis?
- To measure therapeutic efficacy
- To detect and quantify impurities or contaminants below a specified limit
- To determine packaging aesthetics
- To replace full quantitative assays
Correct Answer: To detect and quantify impurities or contaminants below a specified limit
Q12. Which pharmacopoeial compendia are commonly harmonized efforts aim to align?
- USP, BP, and IP
- WHO list and company SOPs only
- Local hospital formularies
- Pharmaceutical marketing brochures
Correct Answer: USP, BP, and IP
Q13. What distinguishes a primary reference standard from a working standard?
- Primary standards are used only for microbiological tests
- Primary standards are highly characterized and used to calibrate working standards
- Working standards are more pure than primary standards
- There is no difference; terms are interchangeable
Correct Answer: Primary standards are highly characterized and used to calibrate working standards
Q14. Which analytical parameter assesses consistency of active ingredient among individual tablets?
- Limit test
- Content uniformity
- Related substances test
- pH measurement
Correct Answer: Content uniformity
Q15. A stability-indicating method is required to:
- Measure only the initial potency of a drug
- Accurately separate and quantify drug and its degradation products
- Replace all pharmacopoeial identification tests
- Assess only microbial contamination over time
Correct Answer: Accurately separate and quantify drug and its degradation products
Q16. Which technique is preferred for volatile impurity profiling in certain monographs?
- HPLC with UV detection
- Gas chromatography (GC)
- Light scattering detector only
- IR spectroscopy exclusively
Correct Answer: Gas chromatography (GC)
Q17. What role do excipient monographs in pharmacopoeias play?
- They define therapeutic doses of excipients
- They set specifications for identity, purity and functional quality of excipients
- They are optional marketing guides
- They list contraindications for excipients
Correct Answer: They set specifications for identity, purity and functional quality of excipients
Q18. Which is a common identification test specified by pharmacopoeias for organic drugs?
- pKa determination only
- Infrared (IR) absorption spectroscopy
- Particle size analysis
- Color of the packaging
Correct Answer: Infrared (IR) absorption spectroscopy
Q19. Pharmacopoeial monographs are revised periodically to address:
- Changes in pharmaceutical marketing trends
- Advances in analytical methods, safety data and impurity concerns
- Company preferences
- Seasonal variations in raw material cost
Correct Answer: Advances in analytical methods, safety data and impurity concerns
Q20. What is the difference between ‘assay’ and ‘identification’ in a monograph?
- Assay confirms identity; identification measures strength
- Assay quantifies amount of active substance; identification verifies chemical identity
- They are the same test with different names
- Identification evaluates stability; assay checks packaging
Correct Answer: Assay quantifies amount of active substance; identification verifies chemical identity
Q21. Which dissolution apparatus is commonly referenced in USP for tablets?
- Paddle apparatus (USP Apparatus II)
- Flow-through cell only
- Vortex mixer
- High-speed centrifuge
Correct Answer: Paddle apparatus (USP Apparatus II)
Q22. What is the significance of ‘related substances’ testing for drug safety?
- It assesses aesthetic properties of the tablet
- It detects impurities that may be toxic or reduce efficacy
- It is only important for sterile products
- It replaces the need for stability testing
Correct Answer: It detects impurities that may be toxic or reduce efficacy
Q23. In pharmacopoeial context, a ‘monograph’ refers to:
- A marketing leaflet for healthcare professionals
- A detailed specification document for a specific drug substance or product
- A patient instruction manual
- An internal lab notebook
Correct Answer: A detailed specification document for a specific drug substance or product
Q24. Which statement about pharmacopoeial methods and company methods is true?
- Company methods never need to be validated
- Company methods must be shown equivalent to pharmacopoeial methods if used for official testing
- Pharmacopoeial methods are optional in regulatory submissions
- Company methods always supersede pharmacopoeial methods
Correct Answer: Company methods must be shown equivalent to pharmacopoeial methods if used for official testing
Q25. What is the role of the International Pharmacopoeia published by WHO?
- To replace all national pharmacopoeias immediately
- To provide international guidance on quality specifications for global public health needs
- To provide marketing authorization templates
- To publish clinical trial results
Correct Answer: To provide international guidance on quality specifications for global public health needs
Q26. Which parameter measured in pharmacopoeial tests helps ensure uniform dose delivery in capsules?
- pH of the capsule shell only
- Weight variation and content uniformity
- Discoloration index
- Osmolality of contents
Correct Answer: Weight variation and content uniformity
Q27. Certificate of Analysis (CoA) differs from a pharmacopoeial monograph because a CoA:
- Is a legal compendial document published by the government
- Reports specific batch test results, whereas a monograph sets general specifications
- Contains pharmacokinetic profiles
- Is identical to a monograph
Correct Answer: Reports specific batch test results, whereas a monograph sets general specifications
Q28. Which validation parameter ensures a chromatographic method produces correct results across its measuring range?
- Specificity only
- Linearity and accuracy
- Color of the solvent
- Package label design
Correct Answer: Linearity and accuracy
Q29. Why are pharmacopoeial microbial tests important for sterile products?
- They measure tablet hardness
- They verify sterility and bioburden limits to protect patient safety
- They predict clinical efficacy directly
- They assess only environmental cleanliness
Correct Answer: They verify sterility and bioburden limits to protect patient safety
Q30. Harmonization of pharmacopoeial standards aims to:
- Increase variability in monographs between countries
- Align tests and specifications to facilitate trade and regulatory convergence
- Eliminate the need for analytical testing
- Limit access to reference standards
Correct Answer: Align tests and specifications to facilitate trade and regulatory convergence
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.
Mail- Sachin@pharmacyfreak.com