Pyrogens & Particulates

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13 Terms

1
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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"

2
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What are the common sources of pyrogens in sterile products?

Solvents, excipients, and manufacturing apparatus"

3
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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"

4
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Which pharmaceutical products require pyrogen testing?

Injections over 15 ml and powders for reconstitution, especially large-volume infusions for direct IV injection"

5
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What are the two main pyrogen tests mentioned for detecting pyrogens?

Rabbit test and Limulus Amoebocyte Lysate (LAL) test"

6
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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"

7
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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"

8
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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"

9
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What are the advantages of the LAL test for pyrogens?

Quick, sensitive, quantifiable, and inexpensive"

10
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What factors can affect the results of the LAL test for pyrogens?

pH and cations can influence the test outcome"

11
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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)"

12
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What are particulate matters in parenteral solutions?

Mobile, undissolved substances unintentionally present in the solution"

13
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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"