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level: Level 2

Questions and Answers List

Question	Answer
-Thermostable, not autoclavable -HMW lipopolysaccharife -may cause fever, malaise, chills, pain	Pyrogen
Test for Pyrogens METHODS	1 BET or Bacterial Endotoxin Test 2 Pyrogen Test
(+) formation of gel/development of color in presence of material endotoxins and lysate of amebocytes of: Limulus polyphemus, Tachypleus tridentatus	BET or Bacterial Endotoxin Test
3 healthy mature rabbits, vary T NMT 1C Received 10mL/kg in ear vein, completing injection within 10 mins after start of administration Rectal temp recorded at 1,2,3 hours injection of 30 mins interval 1 hour after injection Apparatus are depyrogenated at 250C, warm sol. to 37C +/- 0.2C Results: No rabbits showed an ind. - rise of 70.5C otherwise: +5 rabbits	Pyrogen Test
Safety Test: detects cytotoxicity of parenteral components	Bioassay
Presence of particles may be harmful because it can cause: __	1 Emboli phlebitis 2 Infusion phlebitis
Particulate Matter Test Equipments:	1 Electronic Particle Counter 2 Membrane Filtration Technique
Measure size, # by means of shadow cast by particles as it passes through high-intensity light beam disadvantage: non-selective (even shadow)	Electronic Particle Counter
Collects particles larger than rated pore size disadvantage: slow counting, saturable	Membrane Filtration Technique