Pharmacy Practice MCQ

Pharmacy Practice MCQ, in this article we will solve, Practice MCQ under subject physical pharmaceutics II. Read following article for your reference.

Accelerated Stability Testing In Expiration Dating Of Pharmaceutical Dosage Forms » PHARMACAREERS

What is the primary purpose of accelerated stability testing?
- A. To determine the final dosage form of a drug
- B. To predict the shelf life of a drug product
- C. To analyze the chemical composition of a drug
- D. To test the efficacy of a drug in animals
Which conditions are typically used in accelerated stability testing?
- A. High humidity and low temperature
- B. Low humidity and high temperature
- C. High temperature and high humidity
- D. Low temperature and low humidity
What does the term “shelf life” refer to in pharmaceuticals?
- A. The time a drug remains effective after opening
- B. The time a drug remains effective during usage
- C. The time a drug remains effective before it is used
- D. The time a drug remains effective under specified storage conditions
How is the expiration date of a pharmaceutical product determined?
- A. Based on the manufacturing date
- B. Based on accelerated stability testing results
- C. Based on the chemical composition of the drug
- D. Based on the regulatory guidelines
Which regulatory body provides guidelines for accelerated stability testing?
- A. WHO
- B. FDA
- C. EMA
- D. All of the above
What is the role of temperature in accelerated stability testing?
- A. To increase the rate of chemical degradation
- B. To slow down the rate of chemical degradation
- C. To maintain the stability of the drug
- D. To evaluate the physical properties of the drug
At what temperature is accelerated stability testing commonly conducted?
- A. 15°C
- B. 25°C
- C. 40°C
- D. 50°C
What is the typical humidity level used in accelerated stability testing?
- A. 40% RH
- B. 60% RH
- C. 75% RH
- D. 90% RH
Why is accelerated stability testing important for pharmaceutical products?
- A. To ensure safety and efficacy throughout the product’s lifecycle
- B. To reduce manufacturing costs
- C. To comply with marketing regulations
- D. To improve packaging design
What can be determined from accelerated stability testing data?
- A. The active ingredient concentration
- B. The degradation rate of the drug
- C. The optimal storage conditions
- D. All of the above
Which parameter is NOT typically measured during stability testing?
- A. Color change
- B. Odor change
- C. Price change
- D. pH change
What is a common outcome of failed stability testing?
- A. Reformulation of the drug
- B. Change in expiration date
- C. Withdrawal of the product from the market
- D. All of the above
What is the significance of humidity in stability testing?
- A. It affects the packaging of the drug
- B. It influences the rate of hydrolysis
- C. It stabilizes the drug formulation
- D. It determines the cost of the drug
What does the term “real-time stability testing” refer to?
- A. Testing at standard storage conditions over a long period
- B. Testing at elevated conditions for a short period
- C. Testing the drug after it is dispensed
- D. Testing the drug during its production
Which of the following is NOT an effect of accelerated conditions on pharmaceuticals?
- A. Increased degradation
- B. Enhanced stability
- C. Faster chemical reactions
- D. Potential change in physical appearance
What does the ICH guideline Q1A(R2) cover?
- A. Pharmaceutical stability testing
- B. Drug safety testing
- C. Clinical trial regulations
- D. Manufacturing process validation
What is the primary goal of stability testing?
- A. To evaluate the taste of the drug
- B. To determine the expiry date
- C. To measure the weight of the drug
- D. To assess the packaging quality
What factors are considered in stability testing?
- A. Temperature, humidity, light
- B. Color, taste, odor
- C. Price, market demand, profit margin
- D. All of the above
What does “RH” stand for in stability testing?
- A. Relative Height
- B. Relative Heat
- C. Relative Humidity
- D. Relative Hardness
What type of products may require specialized stability testing conditions?
- A. Solid dosage forms
- B. Liquid dosage forms
- C. Biologics and vaccines
- D. Generic drugs
How often should stability testing be performed on pharmaceuticals?
- A. Once during the product’s lifecycle
- B. Periodically throughout the product’s lifecycle
- C. Only before product launch
- D. Only after product launch
What is the importance of the “expiration date” on drug packaging?
- A. It indicates when the drug is manufactured
- B. It shows when the drug will be out of stock
- C. It provides the last date the drug is expected to remain effective
- D. It signifies the marketing approval date
What kind of stability testing is conducted at 25°C and 60% RH?
- A. Accelerated stability testing
- B. Intermediate stability testing
- C. Long-term stability testing
- D. Stress testing
What does “ICH” stand for?
- A. International Conference on Harmonisation
- B. International Committee on Health
- C. Institute of Clinical Health
- D. International Coalition of Hospitals
What might be an indicator of chemical instability in a drug?
- A. Change in physical appearance
- B. Decrease in active ingredient potency
- C. Increase in impurity levels
- D. All of the above
Why might a company perform photostability testing?
- A. To assess the drug’s stability under light exposure
- B. To determine the drug’s flavor profile
- C. To evaluate the drug’s market potential
- D. To reduce production costs
What is the usual duration for long-term stability testing?
- A. 1 month
- B. 3 months
- C. 6 months
- D. 12 months or longer
Why are stability-indicating assays important?
- A. They measure the physical properties of the drug
- B. They detect any changes in the chemical composition of the drug
- C. They assess the marketing strategy of the drug
- D. They evaluate the drug’s flavor and color
What does the term “forced degradation study” refer to?
- A. Testing the drug under normal storage conditions
- B. Testing the drug under extreme conditions to induce degradation
- C. Testing the drug during clinical trials
- D. Testing the drug after it is dispensed
What is the relevance of stability testing to patients?
- A. It ensures the effectiveness and safety of the drug throughout its shelf life
- B. It reduces the cost of the drug
- C. It improves the taste of the drug
- D. It enhances the marketability of the drug

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