Compute Expiration Date and Predict Shelf Life in Pharmaceutical Formulations
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Questions and Answers

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?

<p>First Expired First Out (C)</p> Signup and view all the answers

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

<p>To prevent degradation and maintain potency (D)</p> Signup and view all the answers

Which factor determines the expiration date of a pharmaceutical product?

<p>Potency at shelf life (A)</p> 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?

<p>Free Hand Method (C)</p> Signup and view all the answers

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

<p>Shelf life (months) (D)</p> Signup and view all the answers

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

<p>25% (D)</p> Signup and view all the answers

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

<p>Least Square Method (C)</p> Signup and view all the answers

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

<p>Making educated guesses (A)</p> 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?

<p>$Expiration Date = Date of Manufacture + Shelf Life$ (A)</p> Signup and view all the answers

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

<p>Clinical studies show that overage is harmful therapeutically (B)</p> 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?

<p>NMT 30% (D)</p> Signup and view all the answers

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

<p>Arranging the data in rows (C)</p> Signup and view all the answers

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

<p>Potency (A)</p> Signup and view all the answers

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

<p>Study each form independently (D)</p> Signup and view all the answers

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

<p>NLT 30% of labeled potency (D)</p> Signup and view all the answers

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