Module 5 Lesson 3 (Parenterals)

Question 1

Products that are intended to
be administered by injection, infusion, or
implantation into the body.

Answer 1

STERILE PRODUCTS

Question 2

Sterile dosage forms intended for
administration by ________________under or
through one or more layers of the skin.

Answer 2

Injection

Question 3

Sterile dosage forms exert their action by directly entering
into the ________ ___________

Answer 3

Systemic Circulation

Question 4

Finished product must be ______, ___________
& free from extraneous insoluble
materials.

Answer 4

STERILE , Non-pyrogenic

Question 5

Quality Control of Parenteral
Product

Answer 5

•Pyrogen test
•LAL Test
•Sterility test
•Clarity test/ Test for Particulate
Matter
•Leaker Test

Question 6

Types of Pyrogen Test

Answer 6

1. In Vivo Pyrogen test (RABBIT TEST)
2. In Vitro Pyrogen test ( Limulus Amebocyte Lysate Test)

Question 7

A complex
of pyrogenic
lipopolysaccharide, a
protein and inert lipid

Answer 7

ENDOTOXIN

Question 8

Test for Bacterial Endotoxin

Answer 8

LAL Test (Limulus Amoebocyte Lysate Test)

Question 9

Other name of Limulus
polyphemus.

Answer 9

HORSESHOE CRAB

Question 10

This test depends on the gelling property
of the lysate of amoebocyte of Limulus
polyphemus (Horseshoe Crab)

Answer 10

LAL Test (Limulus Amoebocyte Lysate Test)

Question 11

POSITIVE form of LAL Test (Limulus Amoebocyte Lysate Test)

Answer 11

A firm gel forms upon inversion

Question 12

NEGATIVE form of LAL Test (Limulus Amoebocyte Lysate Test)

Answer 12

No gel is formed

Question 13

An aqueous extract of blood cells from blue blooded horseshoe crab.

Answer 13

Limulus Amebocyte Lysate (LAL)

Question 14

Used for endotoxin detection

Answer 14

LAL Test

Question 15

It should be carried out in Aseptic Conditions

Answer 15

STERILITY TEST

Question 16

2 Methods of Sterility

Answer 16

A. Membrane Filtration Method
B. Direct Inoculation Method

Question 17

Biological Indicators

Answer 17

Method of Sterilization
• Moist heat (autoclave)
• Dry heat (oven)
• Ethylene oxide
• Radiation

Bacteria used
1. B. stearothermophilus
• B. subtilis
2. B. stearothermophilus
• Both + B. pumilus

Question 18

Other name of Test for Particulate
Matter

Answer 18

CLARITY TEST

Question 19

2 Methods of Clarity Test

Answer 19

Visual method
Coulter counter method

Question 20

It is the most used and relevant method for clarity testing.

Answer 20

VISUAL METHOD

Question 21

According to this method, the filled containers are examined
against a strong illuminating background with a swirling
motion since moving particles are easier to identify than
stationary particles.

Answer 21

VISUAL METHOD

Question 22

Dark background- _______ particles

Answer 22

LIGHT

Question 23

Light background- ________particles

Answer 23

DARK

Question 24

This is the test that is based on the principle that there
will be an increase in the resistance as a particle
approaches and passes through the orifice (2
electrodes)

Answer 24

COULTER COUNTER METHOD

Question 25

This method require destruction of the product unit since an electrolyte is added to the preparation before its evaluation.

Answer 25

COULTER COUNTER METHOD

Question 26

Other Methods of Clarity Test

Answer 26

•Membrane Filtration technique •Light Scattering

Question 27

Employed to detect incompletely sealed ampoule so that they may be discarded.

Answer 27

LEAKER TEST

Question 28

To test the package integrity.

Answer 28

LEAKER TEST

Question 29

4 Types of Leaker Tests

Answer 29

Visual inspection Bubble test Dye test Vacuum ionization

Question 30

Test that carried out to check the particulate matter in the sample

Answer 30

CLARITY TEST

Question 31

Filter used for aqueous, oily and weakly alcoholic solutions.

Answer 31

CELLULOSE NITRATE FILTERS

Question 32

Filter used for strongly alcoholic solutions.

Answer 32

CELLULOSE ACETATE FILTERS

Question 33

Suitable method for aqueous solutions, oily liquids, ointments and creams.

Answer 33

DIRECT INOCULATION METHOD

Question 34

No growth means the test is ________.

Answer 34

POSITIVE

Question 35

What % of dye solution in Leaker Tests?

Answer 35

1% Methylene blue

Question 36

The test in which the test sample is passed through a sterilized membrane and inoculated into the media for the growth of microorganisms.

Answer 36

Membrane Filtration Method

Question 37

The test sample is directly inoculated into the media in order to observe the growth of the microorganisms.

Answer 37

DIRECT INOCULATION METHOD

Question 38

This method do not passed through 0.45mm in membrane filter.

Answer 38

Direct Inoculation Method

Question 39

This method passed through 0.45mm in membrane filter.

Answer 39

Membrane Filtration Method

Question 40

Requires membrane filtration unit.

Answer 40

Membrane Filtration Method

Question 41

Does not require membrane filtration unit.

Answer 41

Direct Inoculation Method

Question 42

Samples are directly inoculated into the media.

Answer 42

Direct Inoculation Method

Question 43

2 Types of Filters of Membrane Filtration Method

Answer 43

Cellulose nitrate filters Cellulose acetate filters