Monographs of herbal drugs – overview MCQs With Answer

Introduction:
This blog presents a focused set of multiple-choice questions on “Monographs of Herbal Drugs” tailored for M.Pharm students taking Herbal and Cosmetic Analysis (MPA 204T). It covers the essential structure and purpose of herbal monographs, key quality parameters (botanical identification, macroscopic/microscopic features, chemical markers, assay methods, contaminants and limits), and regulatory references like pharmacopoeias and WHO monographs. Questions emphasize practical aspects of drafting, validating and applying monographs for standardization, quality control and stability assessment of herbal materials and formulations. Use these MCQs to test and deepen your understanding of how monographs ensure safety, efficacy and reproducible quality in herbal drug development and analysis.

Q1. What is the primary purpose of a herbal drug monograph?

• To provide a marketing description for herbal supplements
• To document the traditional uses of a plant in folklore
• To define standardized specifications and analytical methods for quality control
• To list manufacturing processes for proprietary herbal products

Correct Answer: To define standardized specifications and analytical methods for quality control

Q2. Which section is typically NOT a standard component of a pharmacopeial monograph for an herbal drug?

• Botanical source and nomenclature
• Macroscopic and microscopic characteristics
• Predicted commercial sales and pricing
• Identification tests and assay methods

Correct Answer: Predicted commercial sales and pricing

Q3. Which analytical technique is most commonly used for quantitative assay of marker compounds in herbal monographs?

• Thin-layer chromatography (TLC) only
• High-performance liquid chromatography (HPLC)
• Polarimetry
• Fluorescence microscopy

Correct Answer: High-performance liquid chromatography (HPLC)

Q4. In herbal monographs, “identity” tests typically include which of the following?

• Only sensory evaluation like smell and color
• Macroscopic, microscopic and chromatographic identification tests
• Only genetic sequencing
• Only chemical assay for potency

Correct Answer: Macroscopic, microscopic and chromatographic identification tests

Q5. A voucher specimen in herbal monographs is important because it:

• Allows future verification of plant identity and source
• Contains the final report of chemical assays
• Replaces the need for chromatographic tests
• Is used only for commercial labeling

Correct Answer: Allows future verification of plant identity and source

Q6. Which pharmacopoeial source is especially relevant for herbal drug monographs in India?

• United States Pharmacopeia (USP) only
• British Pharmacopoeia (BP) only
• Indian Pharmacopoeia (IP)
• European Pharmacopoeia (EP) only

Correct Answer: Indian Pharmacopoeia (IP)

Q7. “Standardization” of herbal drugs as described in monographs most accurately means:

• Ensuring all batches have identical botanical source and identical full phytochemical profiles
• Defining acceptable ranges for key constituents and quality attributes using validated methods
• Guaranteeing clinical efficacy for all indications
• Using only synthetic marker compounds in formulations

Correct Answer: Defining acceptable ranges for key constituents and quality attributes using validated methods

Q8. Which of the following is commonly specified as a contaminant limit in herbal drug monographs?

• Acceptable percentage of therapeutic activity
• Maximum allowable levels of heavy metals like lead and arsenic
• Minimum allowable microbial counts for finished drugs
• Guaranteed pesticide-free status without testing

Correct Answer: Maximum allowable levels of heavy metals like lead and arsenic

Q9. Chromatographic “fingerprinting” in a monograph primarily serves to:

• Quantify every compound present in the herb
• Provide a reproducible pattern to identify and compare batches
• Replace microscopic identification
• Measure biodegradability of plant material

Correct Answer: Provide a reproducible pattern to identify and compare batches

Q10. DNA barcoding included in modern monographs is mainly used to:

• Determine the concentration of active constituents
• Authenticate botanical identity and detect adulteration
• Assess pharmacological activity in vitro
• Standardize extraction solvent composition

Correct Answer: Authenticate botanical identity and detect adulteration

Q11. When a monograph prescribes an extraction procedure for assay, the reason is to:

• Speed up manufacturing irrespective of reproducibility
• Ensure consistent sample preparation for the specified analytical method
• Guarantee the highest possible yield for industrial production
• Provide a medicinal dose recommendation

Correct Answer: Ensure consistent sample preparation for the specified analytical method

Q12. Stability testing information in a herbal monograph helps to determine:

• The best marketing strategy for the herb
• Shelf life, storage conditions and allowable changes in key constituents over time
• The exact therapeutic dose for every patient
• Soil requirements for cultivation

Correct Answer: Shelf life, storage conditions and allowable changes in key constituents over time

Q13. Marker compounds selected in a monograph are chosen because they:

• Are always the only active principles responsible for all pharmacological effects
• Are analytically convenient, characteristic of the plant and correlate reasonably with quality
• Are the most expensive compounds to analyze
• Always represent contaminants to be removed

Correct Answer: Are analytically convenient, characteristic of the plant and correlate reasonably with quality

Q14. Which validation parameter is essential when a monograph includes an HPLC assay?

• Selectivity, accuracy, precision, linearity and robustness
• Only accuracy and color change
• Only operator preference
• Brand of HPLC system used in development

Correct Answer: Selectivity, accuracy, precision, linearity and robustness

Q15. The WHO monographs on medicinal plants primarily provide:

• Global harmonized regulatory approval for herbal medicines
• Monographs with quality-control methods, safety and efficacy summaries for member countries to reference
• Marketing materials for herbal companies
• Detailed agricultural manuals for crop production

Correct Answer: Monographs with quality-control methods, safety and efficacy summaries for member countries to reference

Q16. In a monograph, “loss on drying” is used to assess:

• The amount of volatile active constituents lost during storage
• Moisture content which can affect stability and microbial growth
• The rate of decomposition of non-volatile alkaloids
• The flavor profile of the herbal drug

Correct Answer: Moisture content which can affect stability and microbial growth

Q17. A limit test included in many herbal monographs (e.g., total ash) primarily evaluates:

• The total organic constituents that determine potency
• The presence of inorganic residue and possible adulteration or contamination
• The exact botanical species
• The therapeutic index of the herb

Correct Answer: The presence of inorganic residue and possible adulteration or contamination

Q18. When monographs recommend a reference standard, the purpose is to:

• Enable qualitative and quantitative comparisons using an authenticated material
• Impose proprietary restrictions on laboratories
• Provide clinical dosage guidelines
• Replace the need for instrument calibration

Correct Answer: Enable qualitative and quantitative comparisons using an authenticated material

Q19. Which statement best distinguishes a pharmacopeial monograph from a literature monograph?

• Pharmacopeial monographs are legally recognized quality standards with validated test methods, while literature monographs summarize published information without legally enforceable specifications
• Literature monographs are always more reliable than pharmacopeial monographs
• Pharmacopeial monographs only describe traditional uses, not analytical methods
• There is no difference between them

Correct Answer: Pharmacopeial monographs are legally recognized quality standards with validated test methods, while literature monographs summarize published information without legally enforceable specifications

Q20. Which of the following best describes “chemotype” information in a herbal drug monograph?

• The soil composition used to cultivate the plant
• A classification based on predominant chemical constituents in different populations of the species
• The traditional therapeutic claims associated with the plant
• The supplier’s trade name for the botanical material

Correct Answer: A classification based on predominant chemical constituents in different populations of the species

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