Pharmaceutical Stability Testing

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What is the primary goal of specifications in drug development?

To ensure the safety and efficacy of the product (correct)

To fully characterize the drug substance and product

To establish good manufacturing practices

To conduct stability testing

What is an important aspect of a validated manufacturing process?

Adherence to good manufacturing practices (correct)

Stability testing

In-process testing

Raw materials testing

What is the purpose of in-process testing?

To conduct stability studies

To monitor the manufacturing process (correct)

To establish the identity of the drug substance

To ensure the quality of the drug product

What is a critical aspect of stability testing?

Accelerated testing conditions Signup and view all the answers

What is the purpose of characterization during drug development?

To establish the specifications of the drug product Signup and view all the answers

What is an important consideration in drug product specifications?

The dose uniformity of the product Signup and view all the answers

What is the primary purpose of accelerated stability testing?

To predict the degradation rate at room temperature Signup and view all the answers

What is the relationship between temperature and degradation rate in stability testing?

The degradation rate increases as the temperature of the test increases Signup and view all the answers

What is the purpose of the Arrhenius equation in stability testing?

To predict the degradation rate at room temperature Signup and view all the answers

What is the significance of 𝑡10 in stability testing?

The time at which the product retains 90% of its original potency Signup and view all the answers

What is the limitation of using accelerated stability testing to predict shelf-life?

The precision of the shelf-life estimate is poor Signup and view all the answers

What is the recommended approach to ensure the stability of a final dosage form?

To carry out long-term stability tests on the final dosage forms under normal storage conditions Signup and view all the answers

What is a key difference between amorphous and crystalline forms of a solid?

Solubility Signup and view all the answers

What happens to amorphous solids upon storage?

They tend to revert to the most stable crystalline form Signup and view all the answers

What is the purpose of accelerated stability studies?

To quickly assess the stability and compatibility of a drug substance Signup and view all the answers

What is the main challenge associated with hygroscopic drugs?

Moisture uptake, which affects formulation and storage requirements Signup and view all the answers

What is the purpose of stress testing in stability studies?

To determine the effect of temperature on drug stability Signup and view all the answers

What conditions are used in stability and compatibility studies?

Elevated temperature with dry conditions, and humidity at 75% RH Signup and view all the answers