18 Questions
What characteristic is important for bioavailability and changes on storage?
Dissolution of a drug substance
How can protection from light be achieved according to the text?
Using primary and secondary packaging made up of light-resistant material
Which factor significantly affects the stability of products according to the text?
Resistance of packaging material to moisture and light
What can reduce the effect of oxygen in products according to the text?
Incorporating oxygen adsorbents such as iron powder
Which study provides insight into the mechanism of changes in reactions?
Kinetic studies
How does moisture sensitivity impact the mechanical strength of products according to the text?
It weakens the mechanical strength
What quality attribute of a drug product is evaluated by pharmaceutical scientists and regulators to determine stability?
Functional changes in dosage forms with time
How can changes in the stability of pharmaceutical products affect drug safety and efficacy?
Changes in chemical or physical properties
Which factor plays a significant role in the degradation rate of pharmaceutical products?
Temperature
How does storage in humid conditions impact the mechanical strength of tablets?
Decreases mechanical strength
In drug stability studies, what specific aspect should be evaluated for physical changes in dosage forms?
Dosage form-specific changes
Which type of reaction can be used to assess chemical stability for drugs and excipients?
Hydrolysis reaction
Why is the reactivity of a drug pH-dependent?
Because the fraction of drug present in different forms depends on the pH of the solution.
How can a water-miscible buffer contribute to the stability of a drug?
By preventing a shift in the pH of the solution.
What is the impact of hygroscopic materials on drug stability?
They absorb moisture from the atmosphere, affecting drug stability.
Why should pharmaceutical air conditioning be set below 40% relative humidity?
To maintain drugs unaffected by relative humidity.
How does temperature impact the decomposition of drugs?
An increase in temperature accelerates decomposition reactions.
How do some buffers potentially affect drug stability through catalysis?
By producing ions that catalyze hydrolysis reactions.
Explore how the reactivity of drugs can be pH-dependent due to their different forms in solution, with a focus on stability and solubility. Learn about the importance of including water-miscible buffers in injectables to prevent pH shifts.
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