Compute Expiration Date and Predict Shelf Life in Pharmaceutical Formulations

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What is the label claim for tablet X?

250 mg (correct)

275 mg

225 mg

200 mg

Why is it stated that the potency at the shelf life of 26 months cannot be 126.4%?

It is within the acceptable limits

It is below the acceptable overage limit

It exceeds the acceptable overage limit (correct)

It doesn't meet the minimum potency requirements

Which of the following is NOT mentioned as a responsibility of a pharmacist in relation to stability studies?

Observe FEFO and expiration dates

Inform and educate patients regarding proper storage and use

Determine the manufacturing process for tablets (correct)

Properly treat and label repackaged products

What does FEFO stand for in the context of pharmaceuticals?

First Expired First Out Signup and view all the answers

Why is it important to observe proper storage conditions for pharmaceutical products?

To prevent degradation and maintain potency Signup and view all the answers

Which factor determines the expiration date of a pharmaceutical product?

Potency at shelf life Signup and view all the answers

What method involves plotting time-temperature points on appropriate graph paper to estimate the shelf life of a formulation?

Free Hand Method Signup and view all the answers

In shelf life prediction, what does the 'x' represent in the equation y = a + bx?

Shelf life (months) Signup and view all the answers

What is the maximum allowable overage percentage for ointments, suppositories, and aerosols when determining expiration dates?

25% Signup and view all the answers

Which statistical method involves estimating shelf life by using retained samples?

Least Square Method Signup and view all the answers

In predicting shelf life, what has the technique evolved from according to the text?

Making educated guesses Signup and view all the answers

What is the correct formula to calculate the expiration date of a product based on the Date of Manufacture and Shelf Life?

$Expiration Date = Date of Manufacture + Shelf Life$ Signup and view all the answers

What is one of the conditions that justifies overages in pharmaceutical preparations?

Clinical studies show that overage is harmful therapeutically Signup and view all the answers

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% Signup and view all the answers

What is one of the steps involved in the least square method for estimating shelf life?

Arranging the data in rows Signup and view all the answers

When predicting shelf life using the least square method, what does 'a' represent?

Potency Signup and view all the answers

What should be done separately when determining overages for different galenical dosage forms?

Study each form independently Signup and view all the answers

What is the maximum allowable overage percentage for a particular ingredient in pharmaceutical preparations?

NLT 30% of labeled potency Signup and view all the answers