18 Questions
What is the label claim for tablet X?
250 mg
Why is it stated that the potency at the shelf life of 26 months cannot be 126.4%?
It exceeds the acceptable overage limit
Which of the following is NOT mentioned as a responsibility of a pharmacist in relation to stability studies?
Determine the manufacturing process for tablets
What does FEFO stand for in the context of pharmaceuticals?
First Expired First Out
Why is it important to observe proper storage conditions for pharmaceutical products?
To prevent degradation and maintain potency
Which factor determines the expiration date of a pharmaceutical product?
Potency at shelf life
What method involves plotting time-temperature points on appropriate graph paper to estimate the shelf life of a formulation?
Free Hand Method
In shelf life prediction, what does the 'x' represent in the equation y = a + bx?
Shelf life (months)
What is the maximum allowable overage percentage for ointments, suppositories, and aerosols when determining expiration dates?
25%
Which statistical method involves estimating shelf life by using retained samples?
Least Square Method
In predicting shelf life, what has the technique evolved from according to the text?
Making educated guesses
What is the correct formula to calculate the expiration date of a product based on the Date of Manufacture and Shelf Life?
$Expiration Date = Date of Manufacture + Shelf Life$
What is one of the conditions that justifies overages in pharmaceutical preparations?
Clinical studies show that overage is harmful therapeutically
In the context of vitamins, what percentage loss of labeled potency is considered normal at the end of the product's validity term?
NMT 30%
What is one of the steps involved in the least square method for estimating shelf life?
Arranging the data in rows
When predicting shelf life using the least square method, what does 'a' represent?
Potency
What should be done separately when determining overages for different galenical dosage forms?
Study each form independently
What is the maximum allowable overage percentage for a particular ingredient in pharmaceutical preparations?
NLT 30% of labeled potency
Learn how to assign the expiration date in pharmaceutical formulations using shelf life calculations and allowable overage for different dosage forms. Explore techniques for predicting shelf life based on accumulated stability data.
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