Study Set Content:
Disadvantages
• Only trained personnel is required.
• Pain on injection.
• Difficult to reverse physiologic effect of drugs.
• Sensitivity or allergic reaction at site of injection.
• Require strict control of sterility and non-pyrogenicity than other formulation.
• More expensive and costly to produce
intended to detect incompletely sealed ampoules or vials so that they can be discarded in order to maintain the sterile conditions of the medicines.
Leaker Test
Tip seals are more likely to be incompletely closed than
pull seals.
Open capillaries or cracks at the point of seal result in
Leakers.
Uses _____ methylene blue
1.0%
Another means of testing for leakers is a_____ which detect presence of pinholes in ampules.
high frequency spark test system
are not subjected to such a vacuum test because of the flexibility of the rubber closure
Bottles and vials
is designed to limit to an acceptable level the risks of febrile reaction in the patient to the administration, by injection, of the product concerned.
Pyrogen Test
The test involves measurement of the rise in body temperature of rabbits following the IV injection of a sterile solution into
ear vein of rabbit.
Test animals: healthy, mature rabbits of _____, preferably of the same variety.
either sex
Recording of Temperature
thermometer, thermistor
Disadvantages:
• Biological variation
- Expensive
- Laborious
- Dose dependent
- Not for antipyretic drug
Sample Size: -___ Rabbits – initial, + ___ rabbits – Retest
3, 5
Acceptance criteria:
- Temp rise for any single rabbit should not be more than
0.5C
Retest: One only rabbit has a temp rise of
0.5C
NMT 3 rabbits exhibit a temp rose of > 0.5C & the total temp rise for all 8 rabbits is
NMT 3.3C
Bacterial Endotoxin Test (LAL)
-Limulus amebocyte lysate Test
Limulus polyphenus –
– horsehoe crab
in vitro assay used to detect the presence and concentration of bacterial endotoxins in drugs and
biological products
Method A –
Gel clot limit test method
