NAPLEX (North American Pharmacist Licensure Examination) Practice Exam

What is the BUD for water-containing topical/dermal and mucosal liquid and semisolid formulations?

1. 1 hour

2. 14 days at controlled cold temperatures

3. 30 days at room temperature

4. 28 days

The correct answer is: 30 days at room temperature

B is incorrect because 14 days at controlled cold temperatures may not be applicable to all situations and storage conditions. Additionally, this answer only applies to formulations specifically containing water. D is incorrect because 28 days is not enough time for a thorough stability evaluation, especially for formulations with potentially sensitive ingredients. A is incorrect because 1 hour is not enough time to properly evaluate the stability of a water-containing formulation. The correct answer is C because 30 days at room temperature allows for a more comprehensive assessment of stability for water-containing formulations, taking into account potential temperature fluctuations and longer storage periods commonly seen in real-world situations.