Introduction to Pharmacopoeias (IP, BP, USP, Extra Pharmacopoeia) MCQs With Answer

Introduction

Pharmacopoeias are the backbone of pharmaceutical quality assurance. The Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), and United States Pharmacopeia–National Formulary (USP–NF) set official standards for drug identity, strength, purity, and performance, while the Extra Pharmacopoeia (Martindale) provides comprehensive drug information. For B. Pharm students, mastering compendial monographs, general chapters, reference standards, assays, dissolution, disintegration, microbial limits, impurities, labeling, and regulatory compliance is essential. This introduction highlights how IP, BP, and USP guide quality control and harmonization, and how Martindale supports clinical decision-making and international nomenclature. Understanding compendial requirements connects formulation science with law, ensuring safe, effective medicines and consistent manufacturing practices. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which statement best defines a pharmacopoeia?

• An index of brand names used by pharmacists
• An official compendium of quality standards for medicines and excipients
• A clinical guideline for prescribing in hospitals
• A database of pharmacokinetic studies only

Correct Answer: An official compendium of quality standards for medicines and excipients

Q2. The “Extra Pharmacopoeia” (Martindale) is primarily:

• An official, legally enforceable standard in all countries
• A clinical and scientific drug reference, not an official standards compendium
• A formulary of drug prices and tenders
• A collection of manufacturing batch records

Correct Answer: A clinical and scientific drug reference, not an official standards compendium

Q3. Which body publishes the Indian Pharmacopoeia (IP)?

• Central Drugs Standard Control Organization (CDSCO)
• Indian Pharmacopoeia Commission (IPC), Ministry of Health and Family Welfare
• World Health Organization (WHO)
• Pharmacy Council of India (PCI)

Correct Answer: Indian Pharmacopoeia Commission (IPC), Ministry of Health and Family Welfare

Q4. The USP–NF is published by:

• United States Food and Drug Administration (FDA)
• United States Pharmacopeial Convention (USP)
• National Institutes of Health (NIH)
• American Pharmacists Association (APhA)

Correct Answer: United States Pharmacopeial Convention (USP)

Q5. The British Pharmacopoeia (BP) is overseen and published by:

• British Pharmacopoeia Commission (BPC), under the UK MHRA
• European Medicines Agency (EMA)
• Royal Pharmaceutical Society (RPS)
• National Health Service (NHS) England

Correct Answer: British Pharmacopoeia Commission (BPC), under the UK MHRA

Q6. What does the combined title USP–NF indicate?

• USP contains dosage forms; NF contains only devices
• USP contains drug and excipient monographs; NF contains clinical guidelines
• USP contains drug substance and product monographs; NF contains excipient monographs
• USP is for sterile products; NF is for nonsterile products

Correct Answer: USP contains drug substance and product monographs; NF contains excipient monographs

Q7. In India, pharmacopoeial compliance for “official” articles is legally enforced under the:

• Pharmacy Act, 1948
• Drugs and Cosmetics Act, 1940 and Rules, 1945
• Patents Act, 1970
• Biomedical Waste Management Rules

Correct Answer: Drugs and Cosmetics Act, 1940 and Rules, 1945

Q8. “General Notices” in a pharmacopoeia are important because they:

• List all retired monographs
• Apply default requirements to all monographs unless otherwise specified
• Provide only historical context with no regulatory value
• Describe only packaging materials

Correct Answer: Apply default requirements to all monographs unless otherwise specified

Q9. Typical sections of a monograph include all EXCEPT:

• Identification tests
• Assay (content of active ingredient)
• Impurities/related substances limits
• Clinical trial endpoints

Correct Answer: Clinical trial endpoints

Q10. Which test best evaluates the in vitro performance of an oral solid dosage form as a surrogate of bioavailability?

• Assay
• Dissolution
• Loss on drying
• Residue on ignition

Correct Answer: Dissolution

Q11. In USP, the general chapter for Dissolution is:

• <701>
• <711>
• <905>
• <61>

Correct Answer: <711>

Q12. “Uniformity of Dosage Units” in USP is primarily assessed by:

• Residue on ignition
• Loss on drying
• Content uniformity or mass variation per criteria
• Peroxide value

Correct Answer: Content uniformity or mass variation per criteria

Q13. Which USP general chapters address Elemental Impurities?

• <231> and <281>
• <232> and <233>
• <467> and <905>
• <61> and <62>

Correct Answer: <232> and <233>

Q14. USP general chapter for Microbial Enumeration Tests (nonsterile) is:

• <61>
• <62>
• <71>
• <1111>

Correct Answer: <61>

Q15. A pharmacopoeial “primary reference standard” is used chiefly to:

• Calibrate routine working standards before use
• Replace all working standards in daily QC
• Set shelf-life for finished products
• Determine recommended clinical dose

Correct Answer: Calibrate routine working standards before use

Q16. BP integrates standards from which regional pharmacopoeia for UK legal purposes?

• United States Pharmacopeia
• European Pharmacopoeia (Ph. Eur.)
• Japanese Pharmacopoeia
• International Pharmacopoeia (WHO)

Correct Answer: European Pharmacopoeia (Ph. Eur.)

Q17. Martindale is especially useful for:

• Validated analytical methods and acceptance criteria
• International drug names, uses, interactions, and clinical guidance
• Legal definitions of “official” articles
• Packaging material pharmacopeial standards

Correct Answer: International drug names, uses, interactions, and clinical guidance

Q18. A Supplement/Addendum to a pharmacopoeia generally:

• Raises drug prices for a fiscal year
• Adds or revises monographs and general chapters between main editions
• Provides only promotional content
• Removes all legacy methods without notice

Correct Answer: Adds or revises monographs and general chapters between main editions

Q19. Pharmacopoeial harmonization primarily aims to:

• Increase the number of tests per product
• Align requirements and methods across compendia to reduce duplication
• Replace national laws with a single global law
• Standardize only labeling text

Correct Answer: Align requirements and methods across compendia to reduce duplication

Q20. In monographs, the phrase “Label it to state …” indicates:

• Optional marketing claims
• Mandatory labeling requirements for compliance
• Instructions for clinicians only
• Batch manufacturing records

Correct Answer: Mandatory labeling requirements for compliance

Q21. Limits for degradation products and related substances are typically found in the:

• Identification section
• Assay section
• Impurities/Related substances section
• Storage section

Correct Answer: Impurities/Related substances section

Q22. Which pairing correctly matches equivalent tests across pharmacopoeias?

• USP Loss on Drying ↔ IP/BP Water Determination
• USP Residue on Ignition ↔ IP/BP Sulphated Ash
• USP Dissolution ↔ IP/BP Disintegration
• USP Sterility Tests ↔ IP/BP Microbial Enumeration

Correct Answer: USP Residue on Ignition ↔ IP/BP Sulphated Ash

Q23. In compendial context, “official date” means the date when:

• A product receives marketing authorization
• A new or revised standard becomes legally enforceable
• The batch is released from QC
• The clinical trial begins

Correct Answer: A new or revised standard becomes legally enforceable

Q24. An IR spectrum concordant with a reference substance is typically an:

• Assay result
• Identification test
• Performance test
• Microbial limit test

Correct Answer: Identification test

Q25. The NF portion of USP–NF primarily contains:

• Excipient monographs and related general chapters
• Only veterinary drug monographs
• Only biological product standards
• Clinical practice guidelines

Correct Answer: Excipient monographs and related general chapters

Q26. In USP, the general chapter for Disintegration is:

• <701>
• <905>
• <711>
• <281>

Correct Answer: <701>

Q27. In USP, “Loss on Drying” is described in:

• <921>
• <281>
• <731>
• <467>

Correct Answer: <731>

Q28. The USP general chapter for Sterility Tests is:

• <61>
• <62>
• <71>
• <1111>

Correct Answer: <71>

Q29. For low-dose potent tablets, the appropriate “Uniformity of Dosage Units” approach is generally:

• Mass variation
• Content uniformity
• Friability
• Hardness

Correct Answer: Content uniformity

Q30. Why is compendial compliance critical across manufacturers and markets?

• It guarantees identical tablet shape worldwide
• It ensures consistent identity, strength, purity, and performance enabling interchangeability
• It focuses mainly on marketing approvals
• It replaces GMP requirements entirely

Correct Answer: It ensures consistent identity, strength, purity, and performance enabling interchangeability

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