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What are pyrogens, and what are their key characteristics?
Fever-inducing substances; non-volatile, thermostable, water-soluble, high molecular weight lipopolysaccharides from gram-negative bacteria cell walls"
What are the common sources of pyrogens in sterile products?
Solvents, excipients, and manufacturing apparatus"
What physiological responses can pyrogens cause in the body?
Reddening of injection site, pain in legs and trunk, high temperature, multiple organ failure, and potentially death"
Which pharmaceutical products require pyrogen testing?
Injections over 15 ml and powders for reconstitution, especially large-volume infusions for direct IV injection"
What are the two main pyrogen tests mentioned for detecting pyrogens?
Rabbit test and Limulus Amoebocyte Lysate (LAL) test"
How does the rabbit test for pyrogens work, and what indicates a failure?
Inject rabbits with formulations and monitor temperature; a combined increase of over 2.65 degrees in three rabbits indicates failure"
What are the advantages and disadvantages of the rabbit test for pyrogens?
Advantages: febrile response similar to humans; Disadvantages: expensive, time-consuming, difficult to quantify, some injections (e.g., insulin) cause similar responses"
What is the basis of the Limulus Amoebocyte Lysate (LAL) test for pyrogens?
An in vitro test detecting bacterial endotoxins using amoebocytes from horseshoe crabs, forming a gel when enzymes react with endotoxins"
What are the advantages of the LAL test for pyrogens?
Quick, sensitive, quantifiable, and inexpensive"
What factors can affect the results of the LAL test for pyrogens?
pH and cations can influence the test outcome"
What is particulate contamination in large-volume parenteral fluids?
Presence of visible and/or subvisible particles, distinct from microbial contamination (living organisms) and pyrogens (non-living)"
What are particulate matters in parenteral solutions?
Mobile, undissolved substances unintentionally present in the solution"
What are the common origins of particulate matter in parenteral solutions?
Raw ingredients (drug, solvent), and materials not filtered out during the clarification stage of manufacturing"