Parenterals Part 4 notes

Particulate Matter In Injections TestMethod 1: Light Obstruction Particle Count TestSVP: (per container)6000 particles  ≥10 micrometers600 particles  ≥25 micrometersLVP: (per ml)25 particles  ≥10 micrometers3 particles  ≥25 micrometersMethod 2: Microscopic Particle Count TestSVP:(per container)3000 particles  ≥10 micrometers300 particles  ≥25 micrometersLVP: (per ml)12 particles  ≥10 micrometers2 particles  ≥25 micrometers

Bacterial Endotoxin TestLAL (Limulus Amebocyte Lysate) reacts with endotoxin or lps --> Gel-like Clot

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