Liquid Dosage Forms 2 Flashcards
(28 cards)
Test that involves the rise in temperature of
healthy and mature rabbits following the
IV injection of test solution
RABBIT PYROGEN TEST
Specific Dose for Rabbit Pyrogen Test
10 mL per kg, unless otherwise specified
Number of mature rabbits in rabbit pyrogen test
3 healthy, mature rabbits
Particles fall under these 3 areas (3)
Foreign
Proteinaceous
Inherent
General area that is Describe as particles for non product material and not related to the product
Foreign
General area that are product related
particularly that is round or amorphous particle that could be translucent to whitish and naturally buoyant in the solution
Proteinaceous
General area that are particles from non
product material related to manufacturing processes.
Inherent
A term for mixture of solid particles and
liquid droplets in the air
Particulate matter
Effects of particulate matter (3)
Emboli
Granulomas
Potent Immunogenic effect
Used in Light obscuration particle count test
ELECTRONIC PARTICLE COUNTERS
Used in Microscopic Particle Count Test
MEMBRANE FILTRATION
Test where Negative pressure within incompletely sealed ampule while submerged in dye solution
Leaker’s Test
Describes the degradation products,
potency
Chemical
Describes appearance
Physical
Test for pH, viscosity, optical activity, refractive index
Physicochemical tests
The instrument used for determined optically activity
Polarimeter
Instrument used for refractive index
Refractometer
the amount of the force necessary to redisperse particles, product is subject to
shaking for minimum of 10 spm
Re-dispersibility
Idea particle size in suspension
the ideal size is 2 μm
Zeta Potential determines the ___________ between particles (stability)
repulsive forces
Two Rheological properties
Viscosity
Flowability
It means flow
Rheology
Temperature used for crystal growth test
40 C
Two methods for testing pathogens in <BET></BET>
Gel-Cloth formation
Turbidimetric method
