IS standards for skin creams and lotions MCQs With Answer

IS standards for skin creams and lotions MCQs With Answer

Introduction: This quiz set focuses on Indian Standards (IS) relevant to skin creams and lotions, tailored for M.Pharm students studying Herbal and Cosmetic Analysis (MPA 204T). It covers fundamental requirements, quality control tests, stability evaluations, microbiological limits, packaging and labeling expectations, and typical analytical methods used to confirm compliance. Questions emphasize practical interpretation of standards: what is tested, why it is tested, and which methods are commonly used. Use these MCQs to review and reinforce concepts necessary for formulation assessment, regulatory submissions, and laboratory quality control of topical cosmetic products.

Q1. What is the primary purpose of IS standards for skin creams and lotions?

• To provide marketing strategies for cosmetic companies
• To ensure quality, safety and standardization of products
• To mandate specific fragrance formulations
• To limit the sale of cosmetic products to hospitals

Correct Answer: To ensure quality, safety and standardization of products

Q2. Which parameter is routinely measured for creams and lotions to assess skin compatibility?

• Boiling point
• pH of the product
• Melting point
• Flash point

Correct Answer: pH of the product

Q3. Which simple test is commonly used to distinguish an oil-in-water (O/W) from a water-in-oil (W/O) emulsion?

• Conductivity test
• Refractive index test
• Determination of acid value
• Saponification number

Correct Answer: Conductivity test

Q4. Which test is specifically used to assess physical stability against phase separation under centrifugal forces?

• Evaporation residue test
• Centrifuge test
• Microbial limit test
• Peroxide value determination

Correct Answer: Centrifuge test

Q5. What is the standard approach to verify the effectiveness of preservatives in creams and lotions as per quality guidelines?

• Peroxide value measurement
• Challenge (preservative efficacy) test
• pH stress testing only
• Boiling for 1 hour

Correct Answer: Challenge (preservative efficacy) test

Q6. Which microbiological specification is typically required for topical creams and lotions?

• High counts of Pseudomonas allowed
• No requirement for microbial testing
• Limits for total viable aerobic count and absence of specified pathogens
• Only fungal counts are checked

Correct Answer: Limits for total viable aerobic count and absence of specified pathogens

Q7. Which analytical determination assesses the non-volatile (residual) content in a cream?

• Non-volatile matter on evaporation
• Water content by Karl Fischer only
• Peroxide value
• Reflectance spectroscopy

Correct Answer: Non-volatile matter on evaporation

Q8. Which instrument is most commonly used in QC labs to measure the flow properties (viscosity) of creams and lotions?

• Gas chromatograph
• Brookfield rotational viscometer
• UV-visible spectrophotometer
• Atomic absorption spectrometer

Correct Answer: Brookfield rotational viscometer

Q9. Which method is frequently applied to evaluate spreadability of topical creams and lotions?

• Glass plate (slide) method
• Thin layer chromatography
• Karl Fischer titration
• Mass spectrometry

Correct Answer: Glass plate (slide) method

Q10. Which heavy metal is of particular concern and is tightly controlled or prohibited in cosmetic preparations according to safety standards?

• Zinc
• Iron
• Mercury
• Magnesium

Correct Answer: Mercury

Q11. For emulsified topical products, which microscopic evaluation is used to assess globule size distribution and detect coalescence?

• Light microscopy with oil immersion
• NMR spectroscopy
• Infrared spectroscopy
• Gas chromatography

Correct Answer: Light microscopy with oil immersion

Q12. Which test helps determine whether an emulsion is susceptible to inversion when diluted with water?

• Dilution test
• Saponification number
• Peroxide value test
• Melting point determination

Correct Answer: Dilution test

Q13. Which storage condition is commonly used for accelerated stability testing of creams and lotions?

• Refrigeration at 2–8 °C for 1 week
• Elevated temperature and humidity (e.g., 40 °C/75% RH) for defined period
• Exposure to direct sunlight for 1 hour only
• Freezing at −20 °C indefinitely

Correct Answer: Elevated temperature and humidity (e.g., 40 °C/75% RH) for defined period

Q14. Which of the following labeling elements is typically required by IS guidelines for topical creams and lotions?

• Batch number and manufacturing date
• Only the color code
• Internal laboratory analyst name
• Distributor’s tax returns

Correct Answer: Batch number and manufacturing date

Q15. What is the significance of conducting an irritancy/sensitization test (e.g., patch test) for topical formulations?

• To measure the product’s boiling point
• To assess potential skin irritation or allergenicity in humans
• To determine the product’s color stability only
• To quantify preservative concentration only

Correct Answer: To assess potential skin irritation or allergenicity in humans

Q16. Which chemical test is relevant when the formulation contains significant unsaturated oils to monitor oxidative rancidity?

• Peroxide value determination
• Saponification number only
• Measurement of freezing point
• Refractive index at 20 °C

Correct Answer: Peroxide value determination

Q17. Why is water activity or total water content important to specify for creams and lotions?

• It determines fragrance intensity exclusively
• It influences microbial growth risk and product stability
• It controls electrical conductivity of the container
• It is irrelevant for topical products

Correct Answer: It influences microbial growth risk and product stability

Q18. Which documentation is essential for regulatory compliance of a cosmetic cream or lotion?

• Product specification and batch release records
• Only the marketing brochure
• Employee payroll details
• Photographs of the manufacturing building only

Correct Answer: Product specification and batch release records

Q19. Which test would detect phase separation or syneresis in a stored cream?

• Observation for oiling off and separation over time
• GC-MS profiling of volatile impurities
• Determination of heavy metal content only
• Measurement of UV absorbance at 280 nm

Correct Answer: Observation for oiling off and separation over time

Q20. Which requirement reflects good manufacturing practice referenced by IS for topical cosmetic products?

• Production without any quality checks to increase speed
• Documentation of batch records, controlled environment and trained personnel
• Using unspecified raw materials is acceptable
• No need to validate cleaning procedures

Correct Answer: Documentation of batch records, controlled environment and trained personnel

Download