Study Set Content:
major air and soil fungal contaminant
Aspergillus niger
The common gram - fermentative enteric bacteria
Escherichia coli
The most common water-borne gram - non- fermentative bacteria
Pseudomonas aeruginosa
The most common gram + bacterial pathogen
Staphylococcus
Microbial concentration
100,000 to 1,000,000 per ml
Interpretation effective if Concentration of the viable bacteria reduce to blank of the original concentration by the 14th day
0.1%
The concentrations of yeasts or molds remain at or below the initial concentration during the first
14 days
The concentration of each microorganism remain at below these designated levels during the remainder of the
28-day test period
Is intended to detect in an article any unexpected, unacceptable biological reactivity.
Safety Test – Biological
Test animals:
select 5 healthy mice weighing between 17 and 23 g
• Systemic Injection Test ▸ Test animal:
albino mice
Intracutaneous Test ▸ Test animal:
: albino rabbits
• Implantation Test ▸ Test animal:
rabbit
Eye Irritation Test ▸ Test animal:
: albino rabbits
Safety Test ▸ Test animal:
mice
USP 7
reciprocating holder
USP 4
flow through
Advantages of parenterals
onset of action
Quick
Suitable for the drugs which are not administered by
Oral route
Useful for (blank)patients
unoperative, nauseous, or unconscious
