Lecture 7 Flashcards
Name the six key determinants of drug quality.
Identity, purity, potency, uniformity, bioavailability, and stability.
What does “identity” mean in the context of drug quality?
It ensures the correct active pharmaceutical ingredient (API) is present
Why is water considered critical in pharmaceutical manufacturing?
It is used as an ingredient, cleaning agent, reagent, solvent, and product, requiring stringent quality control.
What are endotoxins, and why are they significant in parenteral QC?
Endotoxins are bacterial toxins that can cause fever or shock when injected, requiring strict testing.
What is the purpose of the dye intrusion test?
To detect cracks in containers by checking for dye penetration.
What are the advantages of the high-frequency spark test over the dye intrusion test?
It is clean, rapid, and avoids the introduction of contaminants.
What does the disintegration test measure?
The time required for tablets to break down into smaller particles for absorption in the body.
