Comparison of Indian and international herbal pharmacopoeias MCQs With Answer

Introduction: The Comparison of Indian and International Herbal Pharmacopoeias is essential for B.Pharm students studying herbal drug standardization, regulatory standards, and quality control. This topic covers differences between the Indian Pharmacopoeia (IP) and the International Pharmacopoeia (Ph. Int.), monograph sections, methods like microscopy, TLC/HPLC, assay procedures, limits for heavy metals, pesticides and microbial contamination, and approaches to authentication including DNA barcoding. Understanding monograph formats, reference standards, and harmonization challenges equips students to evaluate phytochemicals, ensure safety, and support herbal drug development. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which organization publishes the International Pharmacopoeia relevant to herbal medicines?

  • United States Pharmacopeia (USP)
  • World Health Organization (WHO)
  • Council of Europe
  • European Pharmacopoeia Commission

Correct Answer: World Health Organization (WHO)

Q2. A key difference between the Indian Pharmacopoeia (IP) and the International Pharmacopoeia (Ph. Int.) is:

  • IP only lists synthetic drugs; Ph. Int. only lists herbal drugs
  • IP focuses on medicines used in India; Ph. Int. targets global public health needs
  • Ph. Int. is legally binding in India; IP is voluntary worldwide
  • IP does not include monographs with test methods

Correct Answer: IP focuses on medicines used in India; Ph. Int. targets global public health needs

Q3. Which section is commonly included in herbal monographs in both IP and Ph. Int.?

  • Clinical trial protocols
  • Taxonomic name and botanical source
  • Prescription pricing guidelines
  • Marketing strategies

Correct Answer: Taxonomic name and botanical source

Q4. Which of the following tests assesses inorganic contamination in herbal drugs?

  • Loss on drying
  • Ash value
  • Thin layer chromatography (TLC)
  • Organoleptic evaluation

Correct Answer: Ash value

Q5. The purpose of reference standards in pharmacopoeias is to:

  • Serve as marketing samples
  • Guide experimental design in pharmacology
  • Provide a defined material for assay and identification tests
  • Replace stability testing

Correct Answer: Provide a defined material for assay and identification tests

Q6. Which analytical technique is most suitable for quantitative estimation of specific phytochemical marker compounds?

  • Macroscopy
  • High-performance liquid chromatography (HPLC)
  • Organoleptic testing
  • Paper chromatography

Correct Answer: High-performance liquid chromatography (HPLC)

Q7. In herbal pharmacopoeial monographs, ‘part used’ refers to:

  • The country where the drug is sold
  • The specific plant organ (e.g., root, leaf) used for medicine
  • The part of the lab where testing occurs
  • The marketing segment targeted

Correct Answer: The specific plant organ (e.g., root, leaf) used for medicine

Q8. Which parameter helps determine moisture content in crude herbal drugs?

  • Limit of heavy metals
  • Loss on drying
  • Extractive value
  • Melting point

Correct Answer: Loss on drying

Q9. TLC/HPTLC fingerprinting in herbal monographs primarily helps to:

  • Measure organoleptic properties
  • Authenticate identity and assess chemical profile
  • Quantify microbial load
  • Determine heavy metal content

Correct Answer: Authenticate identity and assess chemical profile

Q10. Which of the following is a common limit test included in herbal pharmacopoeias?

  • Viscosity index
  • Pesticide residue limits
  • Electrical conductivity of extract
  • Color preference test

Correct Answer: Pesticide residue limits

Q11. DNA barcoding is included in some modern pharmacopoeial approaches to:

  • Replace all chemical assays
  • Authenticate botanical identity at species level
  • Assess inorganic contaminants
  • Measure extractive values

Correct Answer: Authenticate botanical identity at species level

Q12. Which ash value indicates inorganic adulteration due to soil or sand?

  • Total ash
  • Acid-insoluble ash
  • Water-soluble ash
  • Carbonate ash

Correct Answer: Acid-insoluble ash

Q13. In herbal monographs, ‘extractive value’ helps to estimate:

  • The inorganic ash content
  • The amount of constituents extractable with a solvent
  • The DNA content
  • The microbial load

Correct Answer: The amount of constituents extractable with a solvent

Q14. Which organization publishes the Indian Pharmacopoeia?

  • Indian Council of Medical Research (ICMR)
  • Pharmacopeia Commission for Indian Medicine
  • Indian Pharmacopoeia Commission (IPC)
  • Central Drugs Standard Control Organization (CDSCO)

Correct Answer: Indian Pharmacopoeia Commission (IPC)

Q15. A pharmacopoeial monograph for an herbal drug typically requires the scientific (Latin) name because:

  • Latin names are easier to pronounce
  • It avoids confusion from vernacular names and ensures precise identification
  • It is required for marketing abroad
  • Latin names indicate chemical constituents directly

Correct Answer: It avoids confusion from vernacular names and ensures precise identification

Q16. Which contamination is specifically monitored by heavy metals limits in pharmacopoeias?

  • Pesticide residues
  • Lead, mercury, cadmium, arsenic
  • Microbial endotoxins
  • Residual solvents

Correct Answer: Lead, mercury, cadmium, arsenic

Q17. Harmonization between national and international pharmacopoeias aims to:

  • Eliminate all monographs for traditional medicines
  • Align standards to facilitate trade and ensure safety
  • Make IP identical to Ph. Int. word-for-word
  • Restrict herbal exports

Correct Answer: Align standards to facilitate trade and ensure safety

Q18. Microbial limits tests in herbal pharmacopoeias are important because:

  • Herbal drugs are immune to microbial growth
  • They ensure products are safe from pathogenic contamination
  • They replace chemical assays
  • They determine plant species

Correct Answer: They ensure products are safe from pathogenic contamination

Q19. Which of the following best describes a ‘monograph’ in a pharmacopoeia?

  • A pricing list for medicines
  • A detailed document specifying identity, purity, tests and assay methods for a drug
  • A clinical guideline for prescribing
  • A marketing leaflet

Correct Answer: A detailed document specifying identity, purity, tests and assay methods for a drug

Q20. For herbal extracts, ‘standardization’ commonly means:

  • Adjusting taste to be uniform
  • Ensuring a specified content of marker compound(s) and consistent quality
  • Making every batch the same color
  • Removing all biological activity

Correct Answer: Ensuring a specified content of marker compound(s) and consistent quality

Q21. Which test differentiates between authentic plant material and adulterants by microscopic features?

  • Macroscopic evaluation
  • Microscopy and powder microscopy
  • HPLC assay
  • UV-Vis spectroscopy

Correct Answer: Microscopy and powder microscopy

Q22. When a pharmacopoeia specifies ‘storage conditions’ for a herbal drug, it addresses:

  • Legal ownership
  • Optimal temperature, humidity and packaging to maintain quality
  • How to advertise the drug
  • Clinical dose recommendations

Correct Answer: Optimal temperature, humidity and packaging to maintain quality

Q23. Which of the following is a challenge unique to herbal pharmacopoeial standardization?

  • Single-component purity is always applicable
  • Complex mixtures and variable phytochemical profiles due to genetics and environment
  • Absence of microbial contamination concerns
  • Herbal drugs do not require analytical methods

Correct Answer: Complex mixtures and variable phytochemical profiles due to genetics and environment

Q24. In the context of pharmacopoeias, ‘assay’ refers to:

  • Identification of the plant family only
  • Quantitative determination of an active or marker constituent
  • Visual inspection for foreign matter
  • Assessment of marketing potential

Correct Answer: Quantitative determination of an active or marker constituent

Q25. Which of these is commonly included in both IP and Ph. Int. monographs for safety assessment?

  • Dosage form patent details
  • Limits for aflatoxins and microbial contaminants
  • Celebrity endorsements
  • Wholesale price lists

Correct Answer: Limits for aflatoxins and microbial contaminants

Q26. Which sampling consideration is important when preparing pharmacopoeial tests for herbal raw material?

  • Single small sample is always sufficient
  • Representative and adequate sample to account for heterogeneity
  • Only the best-looking pieces should be sampled
  • Sampling is unnecessary for herbal drugs

Correct Answer: Representative and adequate sample to account for heterogeneity

Q27. A pharmacopoeial identification test that compares Rf values and spot colors against a reference is:

  • Acid-insoluble ash test
  • TLC identification
  • Loss on drying
  • pH measurement

Correct Answer: TLC identification

Q28. Which statement about monograph updates is true?

  • Pharmacopoeias never update monographs once published
  • Monographs are periodically revised to include new science, methods, and safety data
  • Updates only occur every 100 years
  • Only country-specific pharmacopoeias can update monographs

Correct Answer: Monographs are periodically revised to include new science, methods, and safety data

Q29. For a polyherbal formulation, pharmacopoeial evaluation may include:

  • Testing only the cheapest raw material
  • Identification and assay of characteristic markers from key ingredients and overall quality tests
  • Ignoring herbal-drug interactions
  • Assessment of color only

Correct Answer: Identification and assay of characteristic markers from key ingredients and overall quality tests

Q30. Which is a reason why an herbal monograph would specify a particular extraction solvent?

  • To ensure consistent extraction of characteristic constituents and reproducible assay results
  • To increase product price
  • To standardize taste preferences
  • To make the extraction process secret

Correct Answer: To ensure consistent extraction of characteristic constituents and reproducible assay results

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