Introduction: Pharmacopoeias are authoritative reference books that set standards for drug identity, purity, strength, and quality, essential for B. Pharm students and future pharmacists. Key compendia include the Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), and United States Pharmacopeia (USP), each providing official monographs, general chapters, and reference standards. Understanding monograph structure, tests (identification, assay, impurities), harmonization efforts, and the concept of Extra Pharmacopoeia resources is vital for quality control, regulatory compliance, and formulation development. This concise guide emphasizes practical principles, terminology, and differences among IP, BP, USP to prepare you for exams and lab practice. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary purpose of a pharmacopoeia?
- To provide clinical treatment guidelines for physicians
- To define official standards for the quality of medicines
- To advertise pharmaceutical companies’ products
- To list prices of drugs in the market
Correct Answer: To define official standards for the quality of medicines
Q2. Which section of a pharmacopoeia contains general testing methods and procedures?
- Monographs
- General chapters
- Index
- Glossary
Correct Answer: General chapters
Q3. A monograph in IP, BP or USP typically includes which of the following elements?
- Therapeutic indications only
- Identification, purity tests, assay, storage conditions
- Pharmacokinetic data and clinical trial results
- Manufacturing company marketing claims
Correct Answer: Identification, purity tests, assay, storage conditions
Q4. Which pharmacopoeia is published by the Indian Pharmacopoeia Commission?
- USP
- BP
- IP
- EP
Correct Answer: IP
Q5. The term “reference standard” in a pharmacopoeia refers to:
- A fictional example compound
- An impure sample used for comparison
- A certified material used to validate tests and assays
- A manufacturing raw material supplier
Correct Answer: A certified material used to validate tests and assays
Q6. Which of the following tests would you expect to find in a pharmacopoeial monograph for a solvent?
- Disintegration time
- Boiling point, refractive index, assay for purity
- Microbial culture sensitivity
- Dose-response in animals
Correct Answer: Boiling point, refractive index, assay for purity
Q7. What does “official” mean when a substance is listed in a pharmacopoeia?
- It is temporarily mentioned for reference only
- It is legally recognized and its standards must be met
- It is obsolete and not to be used
- It is recommended for experimental research only
Correct Answer: It is legally recognized and its standards must be met
Q8. Which pharmacopoeia is most commonly used in the United States for regulatory purposes?
- BP
- IP
- USP
- JP
Correct Answer: USP
Q9. Harmonization between pharmacopoeias aims to:
- Eliminate all national pharmacopoeias
- Standardize test methods and monograph content across regions
- Reduce the number of medicines available
- Promote a single global manufacturer
Correct Answer: Standardize test methods and monograph content across regions
Q10. Which part of a monograph specifies limits for impurities?
- Identification
- Assay
- Description
- Purity or impurities section
Correct Answer: Purity or impurities section
Q11. “Extra Pharmacopoeia” in an MCQ context most likely refers to:
- Information beyond official pharmacopoeial monographs such as textbooks and formularies
- An official chapter within IP
- A brand name list in BP
- An obsolete USP appendix
Correct Answer: Information beyond official pharmacopoeial monographs such as textbooks and formularies
Q12. Which general chapter would you consult for chromatographic system suitability requirements?
- Identification tests
- Assay by titration
- Chromatography general chapter
- Shelf-life guidance
Correct Answer: Chromatography general chapter
Q13. The official monograph assay method is used to:
- Determine therapeutic dose in humans
- Quantify the active ingredient in a sample
- Show color of the formulation
- Measure market demand
Correct Answer: Quantify the active ingredient in a sample
Q14. What is an official general chapter that addresses microbial limits for non-sterile products?
- Disintegration
- Microbial Limits
- Uniformity of Dosage Units
- Related Substances
Correct Answer: Microbial Limits
Q15. Which pharmacopoeia introduced major harmonization efforts through Ph. Eur., USP, and JP collaborations?
- Only IP
- Regional collaborations like Ph. Eur., USP and JP aimed at harmonization
- WHO exclusively
- Only national pharmacopeial committees with no collaboration
Correct Answer: Regional collaborations like Ph. Eur., USP and JP aimed at harmonization
Q16. When a manufacturer follows a pharmacopoeial monograph, this helps ensure:
- Faster marketing approval irrespective of quality
- Compliance with recognized quality standards and regulatory acceptance
- Reduced need for quality control testing
- Guaranteed therapeutic superiority over competitors
Correct Answer: Compliance with recognized quality standards and regulatory acceptance
Q17. In pharmacopoeial terminology, “assay” refers to:
- A stability study over years
- Quantitative measurement of an active constituent
- A test for color and odor only
- Clinical trial design
Correct Answer: Quantitative measurement of an active constituent
Q18. Which of the following is a major difference between IP, BP and USP?
- Only USP contains monographs for chemicals
- Monograph numbering, presentation, and some specific tests and acceptance limits differ
- IP is not legally enforceable in India
- BP is identical to USP in all content
Correct Answer: Monograph numbering, presentation, and some specific tests and acceptance limits differ
Q19. What role does the World Health Organization (WHO) play in pharmacopoeial standards?
- WHO manufactures reference standards
- WHO issues International Pharmacopoeia and promotes harmonization and quality guidance
- WHO replaces all national pharmacopoeias
- WHO enforces national drug laws
Correct Answer: WHO issues International Pharmacopoeia and promotes harmonization and quality guidance
Q20. Which test would be used to check tablet dissolution as per a pharmacopoeial monograph?
- Disintegration test only
- Dissolution test apparatus and conditions specified in monograph
- Assay by HPTLC only
- Melting point determination
Correct Answer: Dissolution test apparatus and conditions specified in monograph
Q21. “Related substances” test in a monograph is aimed at detecting:
- Only the active ingredient
- Degradation products and impurities related to the drug substance
- Microbial contamination exclusively
- Physical defects like cracks
Correct Answer: Degradation products and impurities related to the drug substance
Q22. Which pharmacopoeial section provides guidance on storage and labeling of substances?
- General Notices and labelling or specific monograph storage statements
- Index only
- Clinical chapter
- Manufacturer’s brochure
Correct Answer: General Notices and labelling or specific monograph storage statements
Q23. What is the significance of “Limit Tests” in pharmacopoeial analysis?
- They are used to check the presence of specified impurities within acceptable limits
- They measure therapeutic efficacy
- They estimate market share
- They are only for vitamins
Correct Answer: They are used to check the presence of specified impurities within acceptable limits
Q24. Which organization is responsible for publishing the British Pharmacopoeia?
- Indian Pharmacopoeia Commission
- United States Pharmacopeial Convention
- British Pharmacopoeia Commission
- World Health Organization
Correct Answer: British Pharmacopoeia Commission
Q25. In the context of pharmacopoeias, what is a “general monograph”?
- A monograph specific to a single drug molecule
- A monograph covering a class of preparations or general requirements applicable to many monographs
- Only a historical note with no testing
- A list of proprietary brands
Correct Answer: A monograph covering a class of preparations or general requirements applicable to many monographs
Q26. Which analytical technique is commonly specified in pharmacopoeias for purity and related substances?
- Organoleptic evaluation only
- Chromatography (HPLC, GC) with specified conditions
- Clinical observation
- Random sampling without method
Correct Answer: Chromatography (HPLC, GC) with specified conditions
Q27. Why must pharmacists be familiar with updates and revisions of pharmacopoeias?
- Because older editions are always more accurate
- To ensure current compliance with legal quality standards and test methods
- To advertise new drugs
- Because revisions only affect pricing
Correct Answer: To ensure current compliance with legal quality standards and test methods
Q28. Which term describes the process of confirming the identity of a drug substance as per a monograph?
- Assay
- Identification
- Formulation
- Marketing
Correct Answer: Identification
Q29. Which of the following is true about statutory status of pharmacopoeias?
- Pharmacopoeias have no role in drug regulation
- They often have legal recognition and are referenced in national drug laws
- They replace all regulatory inspections
- They are only academic suggestions with no enforcement
Correct Answer: They often have legal recognition and are referenced in national drug laws
Q30. When a drug product fails a pharmacopoeial test, the manufacturer should:
- Ignore the result and proceed to market
- Investigate cause, perform root-cause analysis, and take corrective action per quality systems
- Immediately change the pharmacopoeia
- Blame the testing laboratory without investigation
Correct Answer: Investigate cause, perform root-cause analysis, and take corrective action per quality systems
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