Liquid Dosage Forms 2

Question 1

Test that involves the rise in temperature of
healthy and mature rabbits following the
IV injection of test solution

Answer 1

RABBIT PYROGEN TEST

Question 2

Specific Dose for Rabbit Pyrogen Test

Answer 2

10 mL per kg, unless otherwise specified

Question 3

Number of mature rabbits in rabbit pyrogen test

Answer 3

3 healthy, mature rabbits

Question 4

Particles fall under these 3 areas (3)

Answer 4

Foreign
Proteinaceous
Inherent

Question 5

General area that is Describe as particles for non product material and not related to the product

Answer 5

Foreign

Question 6

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

Answer 6

Proteinaceous

Question 7

General area that are particles from non
product material related to manufacturing processes.

Answer 7

Inherent

Question 8

A term for mixture of solid particles and
liquid droplets in the air

Answer 8

Particulate matter

Question 9

Effects of particulate matter (3)

Answer 9

Emboli
Granulomas
Potent Immunogenic effect

Question 10

Used in Light obscuration particle count test

Answer 10

ELECTRONIC PARTICLE COUNTERS

Question 11

Used in Microscopic Particle Count Test

Answer 11

MEMBRANE FILTRATION

Question 12

Test where Negative pressure within incompletely sealed ampule while submerged in dye solution

Answer 12

Leaker’s Test

Question 13

Describes the degradation products,
potency

Answer 13

Chemical

Question 14

Describes appearance

Answer 14

Physical

Question 15

Test for pH, viscosity, optical activity, refractive index

Answer 15

Physicochemical tests

Question 16

The instrument used for determined optically activity

Answer 16

Polarimeter

Question 17

Instrument used for refractive index

Answer 17

Refractometer

Question 18

the amount of the force necessary to redisperse particles, product is subject to
shaking for minimum of 10 spm

Answer 18

Re-dispersibility

Question 19

Idea particle size in suspension

Answer 19

the ideal size is 2 μm

Question 20

Zeta Potential determines the ___________ between particles (stability)

Answer 20

repulsive forces

Question 21

Two Rheological properties

Answer 21

Viscosity
Flowability

Question 22

It means flow

Answer 22

Rheology

Question 23

Temperature used for crystal growth test

Answer 23

40 C

Question 24

Two methods for testing pathogens in <BET></BET>

Answer 24

Gel-Cloth formation
Turbidimetric method

Question 25

+ result for Gel-Cloth

Answer 25

Gel-Cloth Formation

Question 26

+ result for turbidimetric method

Answer 26

Turbidity

Question 27

What are the common sources of particulate matter? (7)

Answer 27

Chemicals
Solvent Impurities
Packaging components
Environment contaminants
Processing equipment
Filter fibers
People

Question 28

It is the ratio of ultimate volume to the original volume before settling

Answer 28

Sedimentation Volume