KVV E-Modules - Pharmaceutical Stability Studies: Shelf–life Prediction, and Thermadynamic Considerations

Quadrant -I (Video)

Pharmaceutical stability studies: shelf life prediction and thermodynamic consideration

Quadrant - II (Study Material)

1. Stability study ppt

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Quadrant - III (Assignments)

1. Pharmaceutical stability studies: shelf life prediction and thermodynamic consideration

Q.1 All questions are compulsory 1. Explain factors affecting stability of pharmaceuticals 2. Explain the methodology for prediction of shelf life. 3. Imagine we are testing a new liquid aspirin formulation. We need to find its shelf life, which is the time it takes for the drug to degrade to 90% of its original concentration.

2. Pharmaceutical stability studies: shelf life prediction and thermodynamic consideration

Q.1 All questions are compulsory 1. Explain factors affecting stability of pharmaceuticals 2. Explain the methodology for prediction of shelf life. 3. Imagine we are testing a new liquid aspirin formulation. We need to find its shelf life, which is the time it takes for the drug to degrade to 90% of its original concentration.

Quadrant - IV (MCQs)

If a drug product follows zero-order kinetics, how does the rate of degradation change as the concentration of the drug …

A: The rate decreases linearly B: The rate remains constant C: The rate becomes zero immediately D: The rate increases exponentially

Which equation is most commonly used to relate the degradation rate of a drug to temperature changes during stability testing?

A: Henderson-Hasselbalch B: Arrhenius C: Noyes-Whitney D: Van Slyke

In the context of stability, what does "Activation Energy" ($E_a$) signify?

A: Total energy of the drug B: Energy barrier for degradation C: Energy of the formulation D: Rate of the reaction

Why is 40°C/75% RH chosen as a standard condition for accelerated stability testing?

A: To mimic tropical weather B: To increase molecular collisions C: To increase molecular collisions D: All of the above

Which factor would most likely cause a deviation from the Arrhenius prediction?

A: Constant humidity B: Change in degradation mechanism C: Use of amber glass D: Low activation energy

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