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QC2 LECTURE > Module 5 Lesson 3 (Parenterals) > Flashcards

Module 5 Lesson 3 (Parenterals) Flashcards

1
Q

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

A

STERILE PRODUCTS

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2
Q

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

A

Injection

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3
Q

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

A

Systemic Circulation

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4
Q

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

A

STERILE , Non-pyrogenic

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5
Q

Quality Control of Parenteral
Product

A

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

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6
Q

Types of Pyrogen Test

A
  1. In Vivo Pyrogen test (RABBIT TEST)
  2. In Vitro Pyrogen test ( Limulus Amebocyte Lysate Test)
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7
Q

A complex
of pyrogenic
lipopolysaccharide, a
protein and inert lipid

A

ENDOTOXIN

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8
Q

Test for Bacterial Endotoxin

A

LAL Test (Limulus Amoebocyte Lysate Test)

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9
Q

Other name of Limulus
polyphemus.

A

HORSESHOE CRAB

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10
Q

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

A

LAL Test (Limulus Amoebocyte Lysate Test)

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11
Q

POSITIVE form of LAL Test (Limulus Amoebocyte Lysate Test)

A

A firm gel forms upon inversion

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12
Q

NEGATIVE form of LAL Test (Limulus Amoebocyte Lysate Test)

A

No gel is formed

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13
Q

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

A

Limulus Amebocyte Lysate (LAL)

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14
Q

Used for endotoxin detection

A

LAL Test

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15
Q

It should be carried out in Aseptic Conditions

A

STERILITY TEST

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16
Q

2 Methods of Sterility

A

A. Membrane Filtration Method
B. Direct Inoculation Method

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17
Q

Biological Indicators

A

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

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18
Q

Other name of Test for Particulate
Matter

A

CLARITY TEST

19
Q

2 Methods of Clarity Test

A

Visual method
Coulter counter method

20
Q

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

A

VISUAL METHOD

21
Q

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.

A

VISUAL METHOD

22
Q

Dark background- _______ particles

A

LIGHT

23
Q

Light background- ________particles

A

DARK

24
Q

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)

A

COULTER COUNTER METHOD

25
Q

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

A

COULTER COUNTER METHOD

26
Q

Other Methods of Clarity Test

A

•Membrane Filtration technique
•Light Scattering

27
Q

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

A

LEAKER TEST

28
Q

To test the package integrity.

A

LEAKER TEST

29
Q

4 Types of Leaker Tests

A

Visual inspection
Bubble test
Dye test
Vacuum ionization

30
Q

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

A

CLARITY TEST

31
Q

Filter used for aqueous, oily and weakly alcoholic solutions.

A

CELLULOSE NITRATE FILTERS

32
Q

Filter used for strongly alcoholic solutions.

A

CELLULOSE ACETATE FILTERS

33
Q

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

A

DIRECT INOCULATION METHOD

34
Q

No growth means the test is ________.

A

POSITIVE

35
Q

What % of dye solution in Leaker Tests?

A

1% Methylene blue

36
Q

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

A

Membrane Filtration Method

37
Q

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

A

DIRECT INOCULATION METHOD

38
Q

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

A

Direct Inoculation Method

39
Q

This method passed through 0.45mm in membrane filter.

A

Membrane Filtration Method

40
Q

Requires membrane filtration unit.

A

Membrane Filtration Method

41
Q

Does not require membrane filtration unit.

A

Direct Inoculation Method

42
Q

Samples are directly inoculated into the media.

A

Direct Inoculation Method

43
Q

2 Types of Filters of Membrane Filtration Method

A

Cellulose nitrate filters
Cellulose acetate filters

QC2 LECTURE (5 decks)

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