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Index
»
QUALITY CONTROL 2 LEC
»
Compendial Requirements for Antibiotics
»
Level 2
level: Level 2
Questions and Answers List
level questions: Level 2
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