Vincristine – industrial production and use MCQs With Answer

Vincristine – industrial production and use MCQs With Answer

Vincristine is a vital vinca alkaloid used in chemotherapy for various cancers. This introduction outlines industrial production and pharmaceutical use, highlighting biosynthesis from Catharanthus roseus, semi-synthetic approaches, fermentation strategies, alkaloid extraction, downstream processing, purification, and formulation. Key concepts include microtubule inhibition, dosing, stability, quality control, GMP, analytical assays, process validation, scale-up challenges, solvent selection, packaging, and environmental/safety considerations. Understanding manufacturing methods — plant extraction versus synthetic modification — and regulatory requirements prepares B.Pharm students for roles in drug development, production, and quality assurance. This concise, keyword-rich overview targets practical industrial knowledge and clinical relevance. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the natural source of vincristine used in industrial production?

• Cinchona officinalis
• Catharanthus roseus
• Taxus brevifolia
• Rauwolfia serpentina

Correct Answer: Catharanthus roseus

Q2. Vincristine’s primary mechanism of anticancer action is:

• DNA intercalation
• Topoisomerase II inhibition
• Microtubule destabilization
• Proteasome inhibition

Correct Answer: Microtubule destabilization

Q3. In industrial extraction, which solvent class is commonly used for initial alkaloid extraction from plant material?

• Nonpolar hydrocarbons (e.g., hexane)
• Polar protic solvents (e.g., water only)
• Polar aprotic or moderately polar solvents (e.g., methanol, ethanol)
• Supercritical carbon dioxide without modifiers

Correct Answer: Polar aprotic or moderately polar solvents (e.g., methanol, ethanol)

Q4. Which downstream purification technique is most commonly used for vincristine at commercial scale?

• Gel electrophoresis
• Preparative HPLC
• Simple filtration
• Distillation

Correct Answer: Preparative HPLC

Q5. Semi-synthetic production of vincristine often involves modification of which plant-derived precursor?

• Vindoline or catharanthine
• Paclitaxel
• Quinine
• Ergoline

Correct Answer: Vindoline or catharanthine

Q6. Which analytical method is standard for quantitative assay of vincristine in bulk drug and formulations?

• UV-Vis spectrophotometry without separation
• Gas chromatography with flame ionization detector
• High-performance liquid chromatography (HPLC) with UV or MS detection
• Polarimetry

Correct Answer: High-performance liquid chromatography (HPLC) with UV or MS detection

Q7. During manufacturing, why is control of pH critical for vincristine extraction and stability?

• Vincristine is stable at all pH values
• pH affects alkaloid ionization, extraction efficiency, and degradation rates
• pH controls color only and is irrelevant to potency
• pH is only important during final packaging

Correct Answer: pH affects alkaloid ionization, extraction efficiency, and degradation rates

Q8. What is a major dosing-limiting toxicity of vincristine relevant to clinical use?

• Cardiotoxicity
• Peripheral neuropathy
• Nephrotoxicity
• Ototoxicity

Correct Answer: Peripheral neuropathy

Q9. Which regulatory practice is essential in vincristine manufacturing to ensure patient safety?

• GMP-compliant cleanrooms and cytotoxic handling procedures
• No documentation is required for sterile cytotoxic drugs
• Only batch release by visual inspection
• Random sampling without validated assays

Correct Answer: GMP-compliant cleanrooms and cytotoxic handling procedures

Q10. For stability testing of vincristine formulations, which condition is particularly monitored?

• Resistance to microbial growth only
• Photostability, since vincristine is light-sensitive
• Effect of magnetic fields
• Vibration during transport exclusively

Correct Answer: Photostability, since vincristine is light-sensitive

Q11. Which formulation form is vincristine commonly supplied as in hospitals?

• Oral tablets
• Intravenous solution or concentrate for injection
• Topical cream
• Inhalation aerosol

Correct Answer: Intravenous solution or concentrate for injection

Q12. Why is accurate potency assay important for vincristine in manufacturing?

• Because small dose variations can cause subtherapeutic effect or severe toxicity
• Potency is irrelevant for cytotoxic drugs
• Only for pricing purposes
• To determine color consistency

Correct Answer: Because small dose variations can cause subtherapeutic effect or severe toxicity

Q13. Which safety precaution is mandatory for personnel handling vincristine in production?

• No special precautions required
• Standard laboratory gloves only
• Use of closed systems, cytotoxic-rated PPE, and engineering controls
• Only respiratory protection is sufficient

Correct Answer: Use of closed systems, cytotoxic-rated PPE, and engineering controls

Q14. What is the role of counter-ion exchange in vincristine purification?

• It converts vincristine into a volatile gas
• It aids in selective binding and elution during chromatographic steps
• It is used to sterilize the product
• It is irrelevant to alkaloid purification

Correct Answer: It aids in selective binding and elution during chromatographic steps

Q15. Which impurity control is critical for vincristine to meet pharmacopeial standards?

• Trace metals only
• Residual plant pigments only
• Related alkaloid impurities and degradation products
• Only microbial contaminants

Correct Answer: Related alkaloid impurities and degradation products

Q16. In scale-up of vincristine extraction, a common challenge is:

• Alkaloid concentration increases linearly without issues
• Maintaining consistent extraction efficiency and impurity profile
• Scaling down is harder than scaling up
• Avoiding solvent purchase

Correct Answer: Maintaining consistent extraction efficiency and impurity profile

Q17. Which chromatographic stationary phase is frequently used for vincristine separation?

• Normal phase silica exclusively
• Reverse-phase C18
• Size-exclusion only
• Ion-exchange exclusively for final sterile product

Correct Answer: Reverse-phase C18

Q18. Which storage condition is recommended for bulk vincristine to preserve potency?

• High temperature and humidity
• Refrigerated, protected from light
• Exposed to direct sunlight
• Frozen solid at −80°C for routine storage

Correct Answer: Refrigerated, protected from light

Q19. What is the importance of solvent removal in the downstream processing of vincristine?

• Solvent presence enhances stability
• Residual solvents can be toxic and must meet ICH limits
• Solvent removal is optional for injectable drugs
• Only solvent color matters

Correct Answer: Residual solvents can be toxic and must meet ICH limits

Q20. Which in-process control would be applied during vincristine chromatographic purification?

• Monitoring UV absorbance at characteristic wavelength
• Measuring only pH of the waste stream
• Counting number of fractions without analysis
• Using smell to detect purity

Correct Answer: Monitoring UV absorbance at characteristic wavelength

Q21. Which packaging consideration is specific for vincristine vials?

• No special labeling required
• Clear label indicating cytotoxic drug, light protection, and handling precautions
• Label only with batch number but no hazard warning
• Packaged as food-grade product

Correct Answer: Clear label indicating cytotoxic drug, light protection, and handling precautions

Q22. What analytical parameter helps detect vincristine degradation in stability studies?

• Change in melting point only
• Appearance of specific degradation peaks in HPLC chromatogram
• Decrease in vial weight only
• Increase in pH without chemical change

Correct Answer: Appearance of specific degradation peaks in HPLC chromatogram

Q23. Why is aseptic technique critical during final vial filling of vincristine?

• Because vincristine promotes microbial growth
• To ensure sterility of injectable cytotoxic product and patient safety
• Only for appearance reasons
• It is not required if closed systems are used

Correct Answer: To ensure sterility of injectable cytotoxic product and patient safety

Q24. Which regulatory document provides limits for residual solvents during vincristine manufacturing?

• ICH Q3C (Impurities: Guideline for Residual Solvents)
• ICH Q9 only
• Pharmacopoeia has no guidance on solvents
• Only internal SOPs, not international guidelines

Correct Answer: ICH Q3C (Impurities: Guideline for Residual Solvents)

Q25. Which pharmacokinetic property of vincristine affects dosing frequency?

• High oral bioavailability
• Rapid renal excretion unchanged
• Extensive tissue distribution and long terminal half-life
• No plasma protein binding

Correct Answer: Extensive tissue distribution and long terminal half-life

Q26. In process validation for vincristine, what is a critical demonstration?

• That the process produces an identical impurity profile in every single batch forever
• That the manufacturing process consistently yields product meeting predefined quality attributes
• Validation is unnecessary for natural products
• That only yield is maximized irrespective of purity

Correct Answer: That the manufacturing process consistently yields product meeting predefined quality attributes

Q27. A common environmental control during vincristine manufacturing is:

• Open handling in general laboratory air
• Use of closed waste containment and proper cytotoxic waste disposal
• Discharging solvent waste without treatment
• Allowing plant material residues to decompose onsite without control

Correct Answer: Use of closed waste containment and proper cytotoxic waste disposal

Q28. Which incompatibility is important when preparing vincristine admixtures for IV administration?

• Compatibility with all electrolytes
• Potential incompatibility with alkaline solutions and certain diluents
• It is always compatible with concentrated dextrose solutions
• Only temperature matters, not diluent choice

Correct Answer: Potential incompatibility with alkaline solutions and certain diluents

Q29. Which quality control test confirms sterility of final vincristine vials?

• Endotoxin test only
• Sterility testing per pharmacopeial methods
• Visual clarity inspection only
• pH measurement only

Correct Answer: Sterility testing per pharmacopeial methods

Q30. What is a contemporary approach to increase vincristine supply sustainability?

• Relying solely on wild-harvested plant material
• Plant cell culture, metabolic engineering, and semi-synthetic routes
• Eliminating quality control to speed production
• Reducing yields to increase cost

Correct Answer: Plant cell culture, metabolic engineering, and semi-synthetic routes

G S Sachin

I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.

Mail- Sachin@pharmacyfreak.com