Permitted colors list under the Act MCQs With Answer offers B.Pharm students a focused review of regulatory requirements, safety assessment, and practical application of colour additives in pharmaceutical formulations. This introduction covers key concepts such as permitted colors list, colour additives, regulatory oversight, labeling requirements, purity testing, stability, lakes versus soluble dyes, and restrictions for sensitive dosage forms. Understanding the Act, pharmacopeial standards, and testing methods (spectrophotometry, HPLC) is essential for formulation, quality control, and regulatory compliance. Clear knowledge of permitted colors helps prevent adverse reactions and ensures product identity and stability. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary purpose of a permitted colors list under a drug regulatory Act?
- To recommend marketing strategies for colored drugs
- To specify approved colour additives and conditions of use
- To ban all synthetic dyes in industry
- To standardize packaging size
Correct Answer: To specify approved colour additives and conditions of use
Q2. Which body typically maintains and updates the permitted colors list under national drug legislation?
- Local pharmacy unions
- National drug regulatory authority
- Individual manufacturing companies
- International retailers
Correct Answer: National drug regulatory authority
Q3. Which analytical technique is commonly used to quantify synthetic colour additives in dosage forms?
- Infrared microscopy
- Spectrophotometry (UV-Vis)
- Karl Fischer titration
- Microscopy particle sizing
Correct Answer: Spectrophotometry (UV-Vis)
Q4. Which pigment is widely accepted as a white permitted color in many pharmacopeias?
- Titanium dioxide
- Sunset yellow
- Amaranth
- Quinoline yellow
Correct Answer: Titanium dioxide
Q5. What is a “lake” colourant in pharmaceutical terminology?
- A soluble dye mixed with sugar
- An insoluble pigment formed by precipitating a dye with a metal salt
- A natural extract from plants
- A volatile colourant used in aerosols
Correct Answer: An insoluble pigment formed by precipitating a dye with a metal salt
Q6. Which dosage form generally restricts the use of colour additives for safety reasons?
- Tablets
- Topical creams
- Parenteral (injectable) preparations
- Oral syrups
Correct Answer: Parenteral (injectable) preparations
Q7. Which of the following is a commonly permitted synthetic blue dye in many formularies?
- Brilliant Blue FCF
- Riboflavin
- Caramel colour
- Annatto
Correct Answer: Brilliant Blue FCF
Q8. Under regulatory evaluation, which parameter is essential to demonstrate for a colour additive before approval?
- Flavor profile
- Toxicological safety and purity
- Market demand
- Cost of manufacture only
Correct Answer: Toxicological safety and purity
Q9. Which natural colourant is often considered for use but requires safety data per the Act?
- Iron oxide red
- Curcumin (turmeric extract)
- Prussian blue
- Indigo carmine
Correct Answer: Curcumin (turmeric extract)
Q10. What is an important stability concern for coloured pharmaceutical products?
- Colourants never interact with APIs
- Photodegradation causing colour changes and potential impurity formation
- Colour stability is irrelevant to shelf life
- Only packaging color matters
Correct Answer: Photodegradation causing colour changes and potential impurity formation
Q11. Which test would you use to detect heavy metal contaminants in a colour additive?
- pH measurement
- Atomic absorption spectroscopy (AAS) or ICP-MS
- Viscosity measurement
- Gram staining
Correct Answer: Atomic absorption spectroscopy (AAS) or ICP-MS
Q12. For labeling, what must manufacturers declare when using permitted colourants in oral solid dosage forms under the Act?
- Exact chemical synthesis route
- Presence of the colour additive on the label or leaflet as required
- Competitor brands using same colour
- No declaration is ever required
Correct Answer: Presence of the colour additive on the label or leaflet as required
Q13. Which of the following is typically NOT allowed as a general permitted colour for pharmaceuticals without special justification?
- FD&C certified dyes meeting pharmacopeial monographs
- Uncharacterized industrial dye mixtures
- Pharmacopeial iron oxides
- Purified natural extracts with safety data
Correct Answer: Uncharacterized industrial dye mixtures
Q14. Why is solubility profile of a colourant important in formulation design?
- It determines the excipient’s taste only
- Solubility affects migration, uniformity, and release characteristics
- Solubility determines market price exclusively
- Soluble colours are always banned
Correct Answer: Solubility affects migration, uniformity, and release characteristics
Q15. Which colour additive class is formed by combining a dye with aluminium to produce an insoluble form suitable for coatings?
- Lake dyes
- Natural extracts
- Carbon black colloids
- Polymeric pigments
Correct Answer: Lake dyes
Q16. In quality control, what indicates improper incorporation of a colourant in tablets?
- Uniform color across all tablets
- Visible mottling or streaks
- Expected dissolution profile
- Consistent weight variation within limits
Correct Answer: Visible mottling or streaks
Q17. Which synthetic yellow dye has been commonly regulated and appears on many permitted lists with limits?
- Sunset Yellow
- Ferric oxide
- Chlorophyll
- Carminic acid
Correct Answer: Sunset Yellow
Q18. What documentation is essential when introducing a new permitted colour into a marketed product?
- Batch photos only
- Stability data, safety/toxicity data, and regulatory approval records
- Only marketing approval copy
- No documentation if colour is inexpensive
Correct Answer: Stability data, safety/toxicity data, and regulatory approval records
Q19. Which test assesses whether a colour additive affects the potency of the active pharmaceutical ingredient (API)?
- Assay of the API after accelerated stability with the colourant
- Particle size distribution of sugar spheres
- Color matching test only
- Moisture sorption isotherm only
Correct Answer: Assay of the API after accelerated stability with the colourant
Q20. Which of the following is a common red pigment used in pharmaceuticals and often listed among permitted colors?
- Ferric ammonium citrate
- Iron oxide red
- Chlorhexidine
- Sodium benzoate
Correct Answer: Iron oxide red
Q21. Why are maximum permitted levels for colourants specified in the permitted colors list?
- To limit manufacturing costs
- To ensure consumer safety and limit exposure to potential toxic impurities
- To standardize tablet sizes
- To restrict color variety only
Correct Answer: To ensure consumer safety and limit exposure to potential toxic impurities
Q22. What is a likely regulatory outcome if a product uses an unlisted colour additive?
- Automatic approval without review
- Regulatory action, product recall, or requirement to submit safety data
- No impact if product is effective
- Only marketing fine
Correct Answer: Regulatory action, product recall, or requirement to submit safety data
Q23. Which of the following interactions is a concern when formulating a coloured oral solution?
- Colourant reacting with flavoring agents to form precipitates
- Colourant improving tablet hardness
- Colourant reducing container volume
- Colourant increasing ambient temperature
Correct Answer: Colourant reacting with flavoring agents to form precipitates
Q24. In regulatory monographs, what additional information is typically provided for each permitted colour?
- Detailed pharmacoeconomic analysis
- Identity, purity criteria, assay methods, and allowable limits
- Trademark registration details
- Recommended marketing slogans
Correct Answer: Identity, purity criteria, assay methods, and allowable limits
Q25. Which colourant class is preferred for stability in film coatings due to low solubility and good heat resistance?
- Water-soluble direct dyes
- Inorganic pigments such as iron oxides and titanium dioxide
- Volatile essential oil colours
- Unstable plant extracts
Correct Answer: Inorganic pigments such as iron oxides and titanium dioxide
Q26. What is the role of pharmacopeial monographs regarding permitted colours?
- They ban scientific testing
- They provide standardized test methods and acceptance criteria for colour additives
- They dictate marketing claims
- They list retail prices only
Correct Answer: They provide standardized test methods and acceptance criteria for colour additives
Q27. Which safety concern is specifically associated with azo dyes used as colour additives?
- Potential formation of aromatic amine impurities with toxicological relevance
- Excessive sweetness
- Strong antimicrobial activity
- Radioactivity
Correct Answer: Potential formation of aromatic amine impurities with toxicological relevance
Q28. When performing a stability study for a coloured formulation, which condition is particularly important to include?
- Only freezing conditions
- Accelerated photostability testing (light exposure)
- Only microbiological stress
- Only taste panel evaluations
Correct Answer: Accelerated photostability testing (light exposure)
Q29. Which document should a manufacturer consult to confirm if a specific colour is permitted for pharmaceutical use in a country?
- Local grocery catalog
- Official drug regulatory authority guidance or permitted colours list and pharmacopeia
- Random internet forum
- Only the supplier’s marketing brochure
Correct Answer: Official drug regulatory authority guidance or permitted colours list and pharmacopeia
Q30. For pediatric formulations, what additional consideration is important when selecting colourants from the permitted list?
- Only cost matters for pediatric use
- Allergenicity, acceptability, and conservative exposure limits due to children’s sensitivity
- Colors should be as intense as possible
- Pediatric formulations never require colorant evaluation
Correct Answer: Allergenicity, acceptability, and conservative exposure limits due to children’s sensitivity
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.
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