Comparative study of herbal pharmacopoeias and monograph parameters MCQs With Answer

Comparative study of herbal pharmacopoeias and monograph parameters MCQs With Answer

This quiz set is designed for M.Pharm students studying Industrial Pharmacognostical Technology and focuses on comparative aspects of major herbal pharmacopoeias and detailed monograph parameters. Questions probe differences in scope, legal authority, monograph structure, identity tests, physicochemical standards, chromatographic fingerprinting, impurity limits, reference standards, and evaluation methods used internationally (e.g., IP, BP, USP, EP, WHO, Chinese and Ayurvedic Pharmacopoeias). The aim is to deepen understanding of how monographs are constructed, interpreted, and updated, and how these standards impact quality control, standardization and regulatory compliance for raw herbal drugs and finished herbal products.

Q1. Which of the following best distinguishes a pharmacopoeia monograph for a crude herbal drug from a monograph for a finished herbal extract?

• Crude drug monographs focus on botanical identification and organoleptic tests, whereas extract monographs emphasise assay of marker compounds and extractive values
• Crude drug monographs always include dissolution testing while extract monographs never do
• Extract monographs do not require microscopic evaluation but crude drug monographs require heavy metals limits
• Crude drug monographs are only concerned with finished product labeling

Correct Answer: Crude drug monographs focus on botanical identification and organoleptic tests, whereas extract monographs emphasise assay of marker compounds and extractive values

Q2. Which pharmacopoeial source is primarily responsible for global guidance on herbal monographs and provides a directory of therapeutic monographs rather than legally binding national standards?

• United States Pharmacopeia (USP)
• British Pharmacopoeia (BP)
• World Health Organization (WHO) monographs
• European Pharmacopoeia (EP)

Correct Answer: World Health Organization (WHO) monographs

Q3. In comparative monograph formats, which parameter is most commonly used to assess inorganic contamination in herbal drugs across IP, BP and USP?

• Moisture content determination
• Ash values (total ash, acid-insoluble ash)
• Thin-layer chromatography (TLC)
• Microbial limit tests

Correct Answer: Ash values (total ash, acid-insoluble ash)

Q4. Which chromatographic technique has become the preferred qualitative fingerprinting method in many modern pharmacopoeia monographs for herbal drugs?

• Paper chromatography
• Gas chromatography with flame ionization detector (GC-FID)
• High Performance Thin Layer Chromatography (HPTLC)
• Partition chromatography

Correct Answer: High Performance Thin Layer Chromatography (HPTLC)

Q5. Which monograph parameter is specifically used to quantify extractable constituents using a defined solvent and is commonly included in IP and BP crude drug monographs?

• Loss on drying
• Extractive value (water-soluble/extractive value)
• Particle size distribution
• Water activity (aw)

Correct Answer: Extractive value (water-soluble/extractive value)

Q6. How do major pharmacopoeias generally differ in their legal status and enforceability?

• All pharmacopoeias are voluntary guidelines with no legal effect in any country
• National pharmacopoeias (e.g., IP, BP) are legally binding within their jurisdictions, while WHO monographs are advisory
• WHO monographs are legally binding worldwide and supersede national laws
• Only the European Pharmacopoeia is legally enforceable globally

Correct Answer: National pharmacopoeias (e.g., IP, BP) are legally binding within their jurisdictions, while WHO monographs are advisory

Q7. Which parameter in herbal monographs specifically addresses microbial contamination limits?

• Ash value
• Microbial limit tests (total aerobic microbial count, specified organisms)
• Thin-layer chromatogram
• pH of aqueous extract

Correct Answer: Microbial limit tests (total aerobic microbial count, specified organisms)

Q8. In comparing monograph contents, which pharmacopoeia is noted for integrating traditional medicine systems (e.g., Ayurvedic) into separate official volumes?

• United States Pharmacopeia
• British Pharmacopoeia
• Indian Pharmacopoeia (including Ayurvedic Pharmacopoeia of India)
• European Pharmacopoeia

Correct Answer: Indian Pharmacopoeia (including Ayurvedic Pharmacopoeia of India)

Q9. Which standard test is commonly required across pharmacopoeial monographs to detect substitution or adulteration with related plant species?

• Assay of marker compound only
• Microscopic and macroscopic authentication including transverse sections and diagnostic characters
• Odour comparison alone
• Residual solvent analysis

Correct Answer: Microscopic and macroscopic authentication including transverse sections and diagnostic characters

Q10. Which parameter addresses the presence of toxic heavy metals in herbal monographs and is often harmonised with international limits?

• Pesticide residue testing
• Heavy metals limits (lead, cadmium, mercury, arsenic)
• Extractive value
• Loss on drying

Correct Answer: Heavy metals limits (lead, cadmium, mercury, arsenic)

Q11. Which pharmacopoeial approach emphasizes chromatographic comparison against a reference standard chromatogram (e.g., TLC/HPTLC plate) rather than solely quantitative assay?

• Exclusive reliance on organoleptic evaluation
• Fingerprinting approach used by many modern monographs (IP, BP, USP herbal chapters)
• Only foreign pharmacopoeias use fingerprinting, national ones do not
• Assay-only approach used universally

Correct Answer: Fingerprinting approach used by many modern monographs (IP, BP, USP herbal chapters)

Q12. When comparing monographs, which parameter would most directly indicate the recommended plant part to be used and its permissible form?

• Assay limit statement
• Definition/Description (includes botanical name, plant part, and form)
• Storage condition clause
• Microbial limit test

Correct Answer: Definition/Description (includes botanical name, plant part, and form)

Q13. Which of the following is a common difference between pharmacopoeias regarding the expression of assay results for marker compounds?

• Some express assay as percentage w/w of raw drug, others as percentage w/w of extract or as mg/g
• All pharmacopoeias always express assay in parts per million only
• Assays are never expressed as percentage in any pharmacopoeia
• Only WHO expresses assays in molar concentration

Correct Answer: Some express assay as percentage w/w of raw drug, others as percentage w/w of extract or as mg/g

Q14. Which monograph element is most relevant when a pharmacopoeia prescribes a specific voucher specimen requirement for botanical authentication?

• Assay procedure
• Reference specimen/voucher deposition and herbarium accession details
• Storage temperature only
• Pesticide residue limits

Correct Answer: Reference specimen/voucher deposition and herbarium accession details

Q15. Which parameter commonly appears in WHO and many national herbal monographs to control agrochemical residues?

• Total ash
• Pesticide residue limits with specified analytical methods
• Particle size distribution
• Heavy metals only, not pesticides

Correct Answer: Pesticide residue limits with specified analytical methods

Q16. Regarding standard reference materials, which statement reflects current pharmacopoeial practice for herbal monographs?

• Pharmacopoeias never provide reference standards; manufacturers must prepare their own
• Pharmacopoeias often provide or endorse chemical reference standards and botanical reference materials for identity and assay
• Only WHO supplies reference standards; national pharmacopeias do not
• Reference standards are irrelevant for herbal drugs

Correct Answer: Pharmacopoeias often provide or endorse chemical reference standards and botanical reference materials for identity and assay

Q17. Which difference between pharmacopoeias affects interpretation of TLC/HPTLC results across regions?

• Number of solvent systems allowed and the acceptance criteria for Rf values and spot colours
• All pharmacopoeias use identical solvent systems and criteria worldwide
• TLC is prohibited by European Pharmacopoeia
• Only gas-phase visualization is permitted universally

Correct Answer: Number of solvent systems allowed and the acceptance criteria for Rf values and spot colours

Q18. In the context of monograph revision frequency, which statement is correct?

• Pharmacopoeial monographs are static and never updated once published
• Monographs are periodically revised; update frequency and procedure differ among pharmacopoeias
• Only WHO revises monographs annually and others never revise
• Revisions only occur when a drug is banned

Correct Answer: Monographs are periodically revised; update frequency and procedure differ among pharmacopoeias

Q19. Which monograph parameter is most critical when a pharmacopoeia prescribes limits for residual solvents in herbal extracts?

• Moisture content determination only
• Residual solvents limits aligned with ICH/ICH Q3C guidance or specified GC methods
• Ash value thresholds
• Visual appearance

Correct Answer: Residual solvents limits aligned with ICH/ICH Q3C guidance or specified GC methods

Q20. Which approach is increasingly recommended in modern pharmacopoeias for ensuring batch-to-batch consistency of herbal extracts?

• Relying solely on macroscopic description and smell
• Combining quantitative assay of one or more marker compounds with fingerprint chromatograms and specified extractive/physicochemical limits
• Only specifying container and label requirements
• Eliminating all analytical testing and using visual QC

Correct Answer: Combining quantitative assay of one or more marker compounds with fingerprint chromatograms and specified extractive/physicochemical limits

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