Laboratory testing and clinical laboratory parameters for herbal products MCQs With Answer

Introduction: This set of MCQs on laboratory testing and clinical laboratory parameters for herbal products is designed for M.Pharm students studying Industrial Pharmacognostical Technology. It focuses on analytical techniques, quality control assays, microbiological and toxicological evaluations, and clinical monitoring relevant to herbal medicines. The questions emphasize practical laboratory procedures, method validation, pharmacopoeial standards, and interpretation of clinical laboratory parameters used during safety assessment and clinical studies. Working through these MCQs will strengthen your understanding of how chemical, biological and clinical tests ensure quality, safety, and consistency of herbal products, and prepare you for advanced coursework and regulatory expectations in herbal product development.

Q1. Which test is primarily used to quantify total aerobic microbial contamination in a powdered herbal extract?

• Total Aerobic Microbial Count (TAMC) by plate count
• Endotoxin testing by LAL assay
• Thin-layer chromatography (TLC) fingerprinting
• High-performance liquid chromatography (HPLC) assay

Correct Answer: Total Aerobic Microbial Count (TAMC) by plate count

Q2. Which analytical technique is most suitable for simultaneous identification and quantification of volatile pesticide residues in herbal samples?

• Atomic absorption spectroscopy (AAS)
• Gas chromatography–mass spectrometry (GC-MS)
• High-performance thin-layer chromatography (HPTLC)
• UV-visible spectrophotometry

Correct Answer: Gas chromatography–mass spectrometry (GC-MS)

Q3. For assessing heavy metal contamination (lead, cadmium, arsenic) in a botanical sample with low detection limits, which method is preferred?

• Fourier-transform infrared spectroscopy (FTIR)
• Inductively coupled plasma–mass spectrometry (ICP-MS)
• Microbial limit test
• Thermogravimetric analysis (TGA)

Correct Answer: Inductively coupled plasma–mass spectrometry (ICP-MS)

Q4. In method validation for an HPLC assay of a herbal marker compound, which parameter specifically evaluates the closeness between measured and true values?

• Specificity
• Precision
• Accuracy
• Robustness

Correct Answer: Accuracy

Q5. Which test would be mandatory to confirm absence of Gram-negative pathogenic bacteria, such as Salmonella, in oral herbal formulations?

• Endotoxin test (LAL)
• Pathogen-specific culture test for Salmonella
• Total yeast and mold count (TYMC)
• HPLC assay of marker compound

Correct Answer: Pathogen-specific culture test for Salmonella

Q6. Which clinical laboratory parameter is most important to monitor hepatotoxic risk during a clinical trial of a novel hepatically metabolized herbal drug?

• Serum creatinine
• Complete blood count (CBC)
• Liver transaminases (ALT and AST)
• Fasting blood glucose

Correct Answer: Liver transaminases (ALT and AST)

Q7. Which guideline or pharmacopeial chapter provides recommended procedures for microbial limit tests applicable to herbal products?

• ICH Q2(R1) Validation of Analytical Procedures
• USP Microbial Enumeration Tests / EP Microbiological Examination
• ICH Q1A(R2) Stability Testing
• ICH Q3C Residual Solvents

Correct Answer: USP Microbial Enumeration Tests / EP Microbiological Examination

Q8. Which parameter of method validation defines the lowest concentration of analyte that can be reliably detected but not necessarily quantified?

• Limit of quantitation (LOQ)
• Linearity range
• Limit of detection (LOD)
• System suitability

Correct Answer: Limit of detection (LOD)

Q9. Which test is most appropriate to detect aflatoxin contamination in powdered herbal ingredients?

• Microbial plate count
• Enzyme-linked immunosorbent assay (ELISA) or LC-MS/MS for aflatoxins
• FTIR spectral matching
• Moisture content by Karl Fischer

Correct Answer: Enzyme-linked immunosorbent assay (ELISA) or LC-MS/MS for aflatoxins

Q10. Which clinical laboratory parameter should be monitored to detect nephrotoxicity associated with prolonged herbal product use?

• Serum alanine aminotransferase (ALT)
• Serum creatinine and blood urea nitrogen (BUN)
• Prothrombin time (PT)
• Serum total cholesterol

Correct Answer: Serum creatinine and blood urea nitrogen (BUN)

Q11. HPTLC fingerprinting of a herbal drug is primarily used to:

• Determine microbial contamination levels
• Provide a chemical profile for identification and batch-to-batch consistency
• Measure heavy metal concentrations
• Evaluate endotoxin content

Correct Answer: Provide a chemical profile for identification and batch-to-batch consistency

Q12. Which residual solvent parameter is typically assessed by GC and must comply with ICH Q3C for herbal extracts prepared using organic solvents?

• Residual pesticide levels
• Residual solvent class and concentration
• Aflatoxin B1 concentration
• Total ash content

Correct Answer: Residual solvent class and concentration

Q13. For endotoxin testing of parenteral herbal extracts, which assay is generally used?

• Plate count method
• Limulus Amebocyte Lysate (LAL) assay
• Thin-layer chromatography
• Atomic absorption spectroscopy

Correct Answer: Limulus Amebocyte Lysate (LAL) assay

Q14. Which of the following clinical lab changes may indicate clinically significant herb–drug interaction causing anticoagulant potentiation?

• Decreased serum potassium
• Prolonged prothrombin time (PT) / increased INR
• Hyperglycemia
• Elevated creatine kinase (CK)

Correct Answer: Prolonged prothrombin time (PT) / increased INR

Q15. In quality control of dried herbal leaves, which parameter best evaluates inorganic residue from soil and extraneous matter?

• Loss on drying (moisture)
• Total ash and acid-insoluble ash
• HPLC assay of marker compound
• Microbial limit test

Correct Answer: Total ash and acid-insoluble ash

Q16. Which immunological parameter might be monitored during clinical evaluation of a botanical with known allergenic potential?

• Serum transaminases (AST/ALT)
• Total serum IgE and specific IgE antibodies
• Hemoglobin A1c

Correct Answer: Total serum IgE and specific IgE antibodies

Q17. Which stability study parameter is most critical to demonstrate that a herbal product’s marker compound remains within specification under accelerated conditions?

• Microbial limit test only
• Assay of marker compound over time with validated stability-indicating HPLC
• Moisture content at a single time point
• Organoleptic evaluation

Correct Answer: Assay of marker compound over time with validated stability-indicating HPLC

Q18. During clinical safety monitoring, a drop in hemoglobin and platelet count after herbal administration suggests which potential concern?

• Hepatoprotective activity
• Hematological toxicity or bone marrow suppression
• Renal filtration enhancement
• Improved lipid profile

Correct Answer: Hematological toxicity or bone marrow suppression

Q19. Which sample preparation technique is commonly required before HPLC analysis of polar marker compounds from plant matrix to reduce matrix interference?

• Direct injection without cleanup
• Solid-phase extraction (SPE)
• Gram staining
• Atmospheric pressure drying

Correct Answer: Solid-phase extraction (SPE)

Q20. Which parameter is essential in a validated analytical method to ensure reproducibility under small deliberate variations such as pH or flow rate changes?

• Accuracy
• Robustness
• Linearity
• LOD

Correct Answer: Robustness

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