Comparative study of monographs – IP vs USP MCQs With Answer

Comparative study of monographs – IP vs USP MCQs With Answer

This short quiz set is designed for M.Pharm students studying Herbal and Cosmetic Analysis (MPA 204T) to deepen understanding of how monographs in the Indian Pharmacopoeia (IP) and United States Pharmacopeia (USP) differ and overlap. The questions focus on practical and regulatory aspects: test procedures, acceptance criteria, reference standards, nomenclature, stability, impurity control, and approaches to herbal monographs and cosmetics. Answers are provided to reinforce learning and prompt further reading. These items go beyond basic definitions to challenge application of monograph principles in formulation analysis, quality control, and regulatory submissions.

Q1. Which fundamental distinction best describes the primary difference between IP and USP monographs?

• They use different languages for writing monographs
• IP is legally binding in India while USP has primary legal status in the USA
• USP covers only synthetic drugs while IP covers only herbal drugs
• IP contains no instrumental methods whereas USP only contains instrumental methods

Correct Answer: IP is legally binding in India while USP has primary legal status in the USA

Q2. When a drug’s assay method differs between IP and USP, which is the most appropriate approach for an exporter from India to the USA?

• Always follow the IP assay because it is origin country monograph
• Perform both IP and USP assays and demonstrate equivalence to the US regulator
• Ignore both and use an in-house validated method only
• Use USP method only when manufacturing in the USA

Correct Answer: Perform both IP and USP assays and demonstrate equivalence to the US regulator

Q3. Which statement about acceptance criteria for impurities in IP versus USP monographs is most accurate?

• IP always sets wider impurity limits than USP
• USP always sets tighter impurity limits than IP
• Impurity limits can differ; acceptance depends on safety data and compendial revision processes
• Neither IP nor USP addresses impurities in monographs

Correct Answer: Impurity limits can differ; acceptance depends on safety data and compendial revision processes

Q4. How do IP and USP typically handle reference standards used in monographs?

• Both provide or endorse official reference standards, but sourcing and certification procedures differ
• Only USP supplies reference standards; IP expects manufacturers to prepare their own
• IP uses only herbal reference materials while USP uses only chemical reference standards
• Neither pharmacopoeia recognizes the use of reference standards

Correct Answer: Both provide or endorse official reference standards, but sourcing and certification procedures differ

Q5. In comparing identification tests for a herbal drug monograph, which difference is commonly observed between IP and USP?

• IP prefers macroscopic and microscopic tests while USP emphasizes chromatographic and spectroscopic techniques
• USP allows only organoleptic tests while IP allows only chemical tests
• Both use identical identification sequences for all herbal drugs
• IP excludes chromatography from herbal identification

Correct Answer: IP prefers macroscopic and microscopic tests while USP emphasizes chromatographic and spectroscopic techniques

Q6. Which monograph element often shows the biggest methodological divergence between IP and USP for the same active pharmaceutical ingredient?

• Color of the packaging
• Dissolution or assay method and sample preparation
• Trade name usage
• Price control measures

Correct Answer: Dissolution or assay method and sample preparation

Q7. If a cosmetic raw material is listed in USP but not in IP, what is the regulatory implication for manufacturing cosmetics in India?

• You must follow USP tests because USP listing overrides local law
• If IP lacks the monograph, follow applicable Indian cosmetic regulations and validated quality tests; USP methods can be used to support quality if acceptable
• Cosmetic products are not regulated in India so no tests are required
• You must discontinue use of the raw material

Correct Answer: If IP lacks the monograph, follow applicable Indian cosmetic regulations and validated quality tests; USP methods can be used to support quality if acceptable

Q8. Which practice improves comparability when IP and USP monographs specify different assay solvents or detectors?

• Switch to a non-validated method that resembles both
• Validate a single method showing equivalence to both compendial assays via method comparison studies
• Choose the cheaper reagents irrespective of performance
• Ignore instrumental parameters and rely on TLC only

Correct Answer: Validate a single method showing equivalence to both compendial assays via method comparison studies

Q9. Which of the following is a common reason IP and USP monographs are revised at different times?

• Different national regulatory priorities and independent expert committees
• One uses lunar calendar scheduling
• Revisions require unanimous international agreement
• Both update only once every 50 years

Correct Answer: Different national regulatory priorities and independent expert committees

Q10. Regarding sterility testing requirements, how do USP and IP compare for sterile herbal injectables if both provide guidance?

• USP typically provides more detailed methodology and compendial sterility procedures, while IP references similar principles but methods or annexes may differ
• IP requires no sterility testing for injectables
• USP allows visual inspection only for sterility
• Both require the same single culture medium and incubation protocol always

Correct Answer: USP typically provides more detailed methodology and compendial sterility procedures, while IP references similar principles but methods or annexes may differ

Q11. Which statement is true about dissolution specifications in IP vs USP monographs for oral solid dosage forms?

• Dissolution apparatus and conditions are harmonized and always identical between IP and USP
• Dissolution conditions (apparatus, medium, rpm) can vary and influence release profiles; bridging data may be required for regulatory acceptance
• IP does not include dissolution tests for any oral solids
• USP prohibits the use of paddle apparatus for dissolution

Correct Answer: Dissolution conditions (apparatus, medium, rpm) can vary and influence release profiles; bridging data may be required for regulatory acceptance

Q12. Which aspect of monographs is particularly important for herbal products and often treated differently in IP and USP?

• Specification of botanical source, part used, identification and marker compounds
• Requirement to add synthetic preservatives
• Mandated color of product label
• Both forbidding chromatographic methods

Correct Answer: Specification of botanical source, part used, identification and marker compounds

Q13. Which is a correct approach when a finished product meets IP monograph limits but fails the USP monograph for the same specification?

• Ship the batch without documentation since IP is local
• Investigate differences, perform additional testing, and consult the importing regulator on acceptable justification or rework
• Change the label to match IP only
• Destroy the product immediately without analysis

Correct Answer: Investigate differences, perform additional testing, and consult the importing regulator on acceptable justification or rework

Q14. How do pharmacopoeial monographs treat residual solvents and their limits when IP and USP differ?

• Residual solvent limits never differ between pharmacopoeias
• Differences reflect adoption of ICH Q3C guidance; manufacturers should comply with the regulator’s accepted list and demonstrate control
• IP allows unlimited residual solvents while USP bans all solvents
• Manufacturers choose any limit they prefer

Correct Answer: Differences reflect adoption of ICH Q3C guidance; manufacturers should comply with the regulator’s accepted list and demonstrate control

Q15. Which best describes how compendial monographs influence Certificate of Analysis (CoA) specifications for exports?

• CoA should reference the monograph used (IP or USP) and show results against that monograph’s tests and limits
• CoA need not mention any pharmacopoeia
• CoA must list all global pharmacopoeias regardless of relevance
• CoA must present only in-house limits and never compendial limits

Correct Answer: CoA should reference the monograph used (IP or USP) and show results against that monograph’s tests and limits

Q16. Which element of monograph harmonization is actively promoted by international bodies to reduce IP–USP discrepancies?

• Elimination of all instrumental tests
• Adoption of uniform reference standards, harmonized methods, and ICH guidelines where applicable
• Replacing monographs with manufacturer manuals
• Banning herbal medicines from pharmacopeias

Correct Answer: Adoption of uniform reference standards, harmonized methods, and ICH guidelines where applicable

Q17. Which statement about labelling of monograph-specific tests in regulatory submissions is correct?

• Labels must state the compendial method verbatim
• Regulatory submissions should describe which compendial monographs were used for release testing and justification for deviations
• Compendial methods are never described in submissions
• Only the IP monograph can be cited in regulatory dossiers worldwide

Correct Answer: Regulatory submissions should describe which compendial monographs were used for release testing and justification for deviations

Q18. When a monograph includes a chromatographic purity test, which factor may cause different results between IP and USP methods?

• Different stationary phase, mobile phase composition, detector wavelength, or system suitability criteria
• Color of the lab coat worn by analyst
• Factory location only
• Time of day the test is performed

Correct Answer: Different stationary phase, mobile phase composition, detector wavelength, or system suitability criteria

Q19. Which practice is advisable when preparing to meet both IP and USP monograph requirements for a new herbal extract?

• Conduct a gap analysis between monographs, validate methods bridging differences, and document stability and marker content to satisfy both sets of criteria
• Only follow the older monograph regardless of content
• Ignore monographs and rely solely on supplier certificates
• Remove all markers to avoid testing

Correct Answer: Conduct a gap analysis between monographs, validate methods bridging differences, and document stability and marker content to satisfy both sets of criteria

Q20. Which of the following correctly reflects the role of expert committees in IP and USP monograph development?

• Expert committees evaluate scientific data, propose method changes, and vote on revisions; national context influences final adoption speed and content
• Expert committees only write labels, not methods
• There are no expert committees; monographs are generated by software
• Committees publish monographs without any stakeholder input

Correct Answer: Expert committees evaluate scientific data, propose method changes, and vote on revisions; national context influences final adoption speed and content

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