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PH 112 - Pharmaceutical Analysis 2 (Lec) > MIDTERM 01 - Finished Product Quality Control > Flashcards

MIDTERM 01 - Finished Product Quality Control Flashcards

1
Q

Shows how well a tablet resists chipping and crumbling when external stresses are applied (Quality control tests for tablets and capsules)

A

Friability test

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2
Q

Device that subjects a number of tablets to the combined effects of abrasion and shock; used in friability test

A

Friabilator

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3
Q

A friabilator revolves at __________ rpm, dropping the tablets at a distance of 6 inches with each revolution (Settings for friabilator)

A

25

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4
Q

A friabilator revolves at 25 rpm, dropping the tablets a distance of __________ inches with each revolution (Settings for friabilator)

A

6

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5
Q

For tablets weighing = or <650 mg, take a sample of whole tablets corresponding as near as possible to __________ g (Procedures for friability test)

A

6.5

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6
Q

For tablets weighing >650 mg, take a sample of __________ whole tablets (Procedures for friability test)

A

10

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7
Q

Rotate the drum __________ times (25 rpm for 4 minutes) (Procedures for friability test)

A

100

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8
Q

Rotate the drum 100 times (25 rpm for __________ minutes) (Procedures for friability test)

A

4

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9
Q

A maximum mean weight loss from the three samples of NMT __________% is considered for most products (Requirements for friability test)

A

1.0%

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10
Q

Process where water is pulled into pores by the disintegrant and reduces the physical bonding forces between particles

A

Wicking

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11
Q

Process where particles swell and breakup the matrix from within due to the disintegrant

A

Swelling

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12
Q

Disintegrants that are mixed with other ingredients prior to granulation and thus be incorporated within the granules (Types of disintegrants)

A

Intragranular disintegrant

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13
Q

Disintegrants that are mixed with the dry granules before the complete powder mix is compacted (Types of disintegrants)

A

Extragranular disintegrant

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14
Q

Apparatus used in disintegration test

A

Basket-rack assembly

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15
Q

Temperature (Basket-rack assembly setting)

A

37°C ± 2°C

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16
Q

Cycles (Basket-rack assembly setting)

A

29-32 cycles/min

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17
Q

Sample size (Basket-rack assembly setting)

A

6 tablets

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18
Q

Place 1 tablet in each of the __________ tubes of the basket, then add the disk to each tube (Procedures for disintegration test)

A

6

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19
Q

Operate the apparatus using water maintained at ___________°C, as the immersion fluid (Procedures for disintegration test)

A

37 ± 2

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20
Q

Lift the basket from the fluid after __________ minutes and observe the tablets (Procedures for disintegration test)

A

30

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21
Q

Plain, coated tablet and capsules (Time requirement for disintegration)

A

Water - 30 mins

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22
Q

Enteric coated tablet (Time requirement for disintegration)

A

Water - 5 minutes soaking
Simulated gastric juice - 1 hour
Simulated intestinal juice - 1 hour

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23
Q

Buccal tablet (Time requirement for disintegration)

A

Water - 4 hours

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24
Q

Sublingual tablets (Time requirement for disintegration)

A

Water - 3 minutes

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25
Q

Used to evaluate as to whether or not a tablet releases its drug contents when placed in the environment of the GI tract (Quality control tests for tablets and capsules)

A

Dissolution test

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26
Q

Useful for tablets, capsules, floaters, beads, and modified release (USP apparatus for dissolution test)

A

Apparatus 1 (Rotating basket/Basket)

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27
Q

Useful for tablets, modified release, and transdermal patch (USP apparatus for dissolution test)

A

Apparatus 2 (Paddle assembly)

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28
Q

First line apparatus in product development of controlled-release preparation (USP apparatus for dissolution test)

A

Apparatus 3 (Reciprocating cylinder/Bio-dis)

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29
Q

Its development was based on the need to establish IVIVC (USP apparatus for dissolution test)

A

Apparatus 3 (Reciprocating cylinder/Bio-dis)

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30
Q

Used for testing of products of poorly-soluble drugs (USP apparatus for dissolution test)

A

Apparatus 3 (Reciprocating cylinder/Bio-dis)

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31
Q

Used for modification of the USP/NF disintegration tester (USP apparatus for dissolution test)

A

Apparatus 3 (Reciprocating cylinder/Bio-dis)

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32
Q

Useful for low solubility drugs, rapid degradation, and media pH change (USP apparatus for dissolution test)

A

Apparatus 4 (Flow-through cell)

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33
Q

Useful for transdermal patch, ointments, floaters, emulsions, and bolus (USP apparatus for dissolution test)

A

Apparatus 5 (Paddle over disk)

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34
Q

Useful for transdermal patch (USP apparatus for dissolution test)

A

Apparatus 6 (Revolving cylinder/Cylinder)

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35
Q

Useful for transdermal patch, solid dosage forms, pH profile, and small volume (USP apparatus for dissolution test)

A

Apparatus 7 (Reciprocating holder)

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36
Q

Assemble the apparatus and equilibrate the dissolution medium to __________°C (Procedures for dissolution test)

A

37 ± 0.5

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37
Q

4 buffers to use for dissolution test (HPAW)

A

HCl, Phosphate butter, Acetate buffer, Water

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38
Q

Volume of buffer to be used in dissolution test

A

900 mL

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39
Q

After __________ min, withdraw a specimen from a zone midway between the surface of the dissolution medium and the top of the rotating basket/paddle NLT 1 cm from the vessel wall (Procedures for dissolution test)

A

30

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40
Q

After 30 min, withdraw a specimen from a zone midway between the surface of the dissolution medium and the top of the rotating basket/paddle NLT __________ cm from the vessel wall (Procedures for dissolution test)

A

1

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41
Q

Sample is 6; All units should have dissolved NLT Q+5%; Q-tolerance is specified in the monograph (Dissolution test stages)

A

Stage 1

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42
Q

Sample is +6; Average number of units NLT Q; No unit less than Q-15% (Dissolution test stages)

A

Stage 2

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43
Q

Sample is +12; Average of 24 units should not be less than Q; NMT 2 units <Q-15%; No unit below Q-25% (Dissolution test stages)

A

Stage 3

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44
Q

Only one sample per vessel is withdrawn (usually after 30 minutes); primarily used in routine quality control testing (Types of dissolution test)

A

Single-time point dissolution test

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45
Q

Multiple samples (>3) are withdrawn from the dissolution medium per vessel at pre-determined time points; primarily used as surrogate for bioequivalence studies (Types of dissolution test)

A

Multiple-time point dissolution test

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46
Q

Uniformity of dosage units are not intended for __________, __________, and __________ (SEG)

A

Suspensions, Emulsions, Gels

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47
Q

Based on the assay of the individual content of drug substances (Quality control tests for tablets and capsules - uniformity of dosage units)

A

Content uniformity

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48
Q

Applied to assure uniform potency for tablets of low dose drugs (Quality control tests for tablets and capsules - uniformity of dosage units)

A

Content uniformity

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49
Q

Provides an idea whether the dose in a batch of units is uniform (Quality control tests for tablets and capsules - uniformity of dosage units)

A

Weight variation

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50
Q

Applied when the dosage form consists of 90-95% of the active ingredient (Quality control tests for tablets and capsules - uniformity of dosage units)

A

Weight variation

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51
Q

________ dosage units are assayed individually according to the method described in the individual monograph (Content uniformity test)

A

10

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52
Q

Unless otherwise stated in the monograph, the requirements for content uniformity are met if the amount of active ingredient in each dosage unit lies within the range of __________ to __________% of the label claim and the SD is less than 6% (Content uniformity test)

A

85-115%

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53
Q

Unless otherwise stated in the monograph, the requirements for content uniformity are met if the amount of active ingredient in each dosage unit lies within the range of 85-115% of the label claim and the SD is less than __________% (Content uniformity test)

A

6%

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54
Q

The number of required sample in content uniformity test is __________ units

A

30

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55
Q

When conducting content uniformity test, one must assay __________ units of solid dosage forms individually

A

10

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56
Q

When conducting content uniformity test, one must assay __________ units of liquid or semi-solid dosage forms individually

A

10

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57
Q

For weight variation test, the assumption is __________

A

Uniform concentration

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58
Q

The number of samples for weight variation test is __________ dosage units of uncoated or film-coated tablets and hard capsules

A

30

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59
Q

Select not fewer than __________ dosage units, and proceed as follows for the dosage form designated (Procedures for weight variation test - tablets)

60
Q

Accurately weigh __________ tablets individually (Procedures for weight variation test - tablets)

61
Q

Accurately weigh __________ capsules individually (Procedures for weight variation test - hard capsules)

62
Q

Determines the maximum packaging quantity of a dosage form and also shows the appropriate packaging material to be used (Quality control tests for tablets and capsules)

A

Tablet thickness test

63
Q

Used to test if tablet has adequate strength to withstand the rigors of mechanical shocks (Quality control tests for tablets and capsules)

A

Tablet hardness test

64
Q

Tablet hardness affects __________, __________, and ___________ (DDB)

A

Dissolution, Disintegration, Bioavailability

65
Q

Uses a spring applied diametrically to a heat (Tablet hardness tester)

A

Stokes-Monsanto

66
Q

Uses force produced by a manually operated air pump (Tablet hardness tester)

A

Strong Cobb

67
Q

Uses pliers (Tablet hardness tester)

68
Q

Uses suspended motor-drive weight (Tablet hardness tester)

69
Q

Uses motor-driven anvil that crushed tablet horizontally (Tablet hardness tester)

A

Schleuniger

70
Q

4 kg (4-10 kg) (Tablet hardness)

A

Conventional tablets

71
Q

7-10 kg (Tablet hardness)

A

Buccal tablets

72
Q

2-3 kg (Tablet hardness)

A

Chewable/SL tablets

73
Q

> 10 kg (Tablet hardness)

A

MR tablets

74
Q

Used to assess the volume of a liquid that is declared on its label (Quality control tests for liquids and semi-solids)

A

Deliverable volume test

75
Q

Deliverable volume test assesses the viscosity of a suspension by using a __________ viscometer

A

Brookfield

76
Q

Deliverable volume test is not required for __________ containers

A

Single-unit

77
Q

The number of samples for deliverable volume test is __________ containers

78
Q

The number of samples for minimum fill test is __________ filled containers

79
Q

Shake the contents of __________ containers individually (Procedures for deliverable volume test)

80
Q

Gently pour the contents into separate dry graduated cylinder for a period not to exceed __________ minutes for multiple containers and 5 seconds for single-unit containers (Procedures for deliverable volume test)

81
Q

Gently pour the contents into separate dry graduated cylinder for a period not to exceed 30 minutes for multiple containers and __________ seconds for single-unit containers (Procedures for deliverable volume test)

82
Q

The average volume of 10 containers must be NLT __________% (Acceptance criteria for deliverable volume test)

83
Q

There must be no container that has a volume less than ___________% of the volume declared in the labeling (Acceptance criteria for deliverable volume test)

84
Q

Tare a 100 mL volumetric flask containing __________ mL of water (Procedures for deliverable volume test)

85
Q

Add approximately __________ g of well-shaken product and gently swirl the contents to mix (Procedure for deliverable volume test)

86
Q

Select not less than __________ containers (Procedure for deliverable volume test)

87
Q

Shake the contents of __________ containers individually (Procedure for deliverable volume test)

88
Q

Discharge the container contents into a suitable tared container in not more than __________ minutes (Procedure for deliverable volume test)

89
Q

Allow each container to drain for a period not to exceed __________ minutes (Procedure for deliverable volume test)

90
Q

The average volume of liquid obtained from 10 containers is NLT __________% and the volume of no container is less than 95% of the volume declared in the labeling (Requirements for deliverable volume test)

91
Q

The average volume of liquid obtained from 10 containers is NLT 100% and the volume of no container is less than __________% of the volume declared in the labeling (Requirements for deliverable volume test)

92
Q

The average content of __________ containers is NLT the labeled amount (Acceptance criteria for minimum fill test)

93
Q

The net content of NMT 1 of the 30 containers is less than __________% for 60 g or 60 mL or less (Acceptance criteria for minimum fill test)

94
Q

The net content of NMT 1 of the 30 containers is less than __________% for 60-150 g or 60 mL-150 mL (Acceptance criteria for minimum fill test)

95
Q

Deliverable volume test is applicable to products labelled to contain NMT __________ mL

96
Q

Pour __________ mL of the emulsion into a test tube (Procedures for dilution test)

97
Q

Add __________ mL of purified water (Procedures for dilution test)

98
Q

Dissolve a __________ g of a water-soluble dye with purified water (Procedures for dye test)

99
Q

Allow the mixture to dry for __________ minutes (Procedures for dye test)

100
Q

Observe the specimen using a microscope with a __________x magnification (Procedures for dilution test)

101
Q

Pour __________ mL of the emulsion in a watch glass (Procedures for fluorescence test)

102
Q

Place the emulsion under UV light in _________ and __________ nm wavelengths (Procedures for conductivity test)

103
Q

Amaranth green - Visible result (Summary of results for emulsion tests)

104
Q

Amaranth green - Type of emulsion (Summary of results for emulsion tests)

105
Q

Sudan red - Visible result (Summary of results for emulsion tests)

106
Q

H2O - Visible results (Summary of results for emulsion tests)

A

Miscible, Immiscible

107
Q

H2O; Miscible - Type of emulsion (Summary of results for emulsion tests)

108
Q

H2O; Immiscible - Type of emulsion (Summary of results for emulsion tests)

109
Q

+CoCl2 - Visible results (Summary of results for emulsion tests)

A

Blue (NVR), Blue → Pink

110
Q

+CoCl2 - Blue (NVR) (Summary of results for emulsion tests)

111
Q

+CoCl2 - Blue → Pink (Summary of results for emulsion tests)

112
Q

UV absorption - Visible result (Summary of results for emulsion tests)

113
Q

UV absorption - Type of emulsion (Summary of results for emulsion tests)

114
Q

Creaming - Visible results (Summary of results for emulsion tests)

A

Upward, Downward

115
Q

Creaming; Upward - Type of emulsion (Summary of results for emulsion tests)

116
Q

Creaming; Downward - Type of emulsion (Summary of results for emulsion tests)

117
Q

Prepare __________ mL of a 1.0% methylene blue (Procedures for Leaker’s test)

118
Q

Remove the label of __________ ampules (Procedures for Leaker’s test)

119
Q

Operate the autoclave at __________°C, __________ psi for __________ minutes (Procedures for Leaker’s test)

A

120; 20; 15

120
Q

Transfer the contents into a dry measuring cylinder of such a capacity that the volume to be determined occupies at least __________% of the nominal volume of the cylinder (Procedures for container content test)

121
Q

Protein obtained from the horseshoe crab, Limulus polyphemus; used in LAL test

A

Limulus amoebocyte lysate

122
Q

LAL is obtained from the horsehoe crab (SN: __________)

A

Limulus polyphemus

123
Q

Coagulation (formation of gel clot) in LAL test indicates the presence of __________

124
Q

Sample is 3; Individual T-rise should be NMT 0.5°C (Rabbit test acceptance criteria)

125
Q

NMT 3/8 units will have >0.5°C; Total rise should not be >3.3°C (Rabbit test acceptance criteria)

126
Q

Device used in tablet thickness test

A

Vernier caliper

127
Q

A filter paper soaked in cobaltous chloride turns __________ in O/W emulsions but remains __________ in W/O emulsions

A

Pink; Blue

128
Q

A water-soluble dye colors __________ emulsions

129
Q

An oil-soluble dye colors __________ emulsions

130
Q

When exposed to UV light, __________ emulsions glow

131
Q

__________ emulsions conduct electricity

132
Q

The test is carried out in a __________ (Procedures for particulate matter test - subvisible)

A

Laminar flow cabinet

133
Q

For SVPs less than __________ mL in volume, the contents of 10 or more units are combined in a cleaned container (Procedures for particulate matter test - subvisible)

134
Q

Average number of particles ≥10 μm does not exceed 12 per mL (Acceptance criteria for particulate matter test - type of container)

A

Containers w/ >100 mL

135
Q

Average number of particles ≥25 μm does not exceed 2 per mL (Acceptance criteria for particulate matter test - type of container)

A

Containers w/ >100 mL

136
Q

Average number of particles present in the units tested does not exceed 3000 per container (Acceptance criteria for particulate matter test - type of container)

A

Containers w/ ≥100 mL

137
Q

Average number of particles present in the units tested does not exceed 300 per container (Acceptance criteria for particulate matter test - type of container)

A

Containers w/ ≥100 mL

138
Q

3 healthy and mature rabbits are warmed to __________ prior to injection (Rabbit test)

A

37 ± 0.2°C

139
Q

Injection not to be used at an interval less than __________ hours or before about two weeks after exhibiting a 0.6°C or more rise in temperature (Rabbit test)

140
Q

Individual temperature vary by not more than 1°C from each other and body temperature is not more than __________°C at the time prior to testing (Rabbit test)

141
Q

In rabbit test, the dose is injected in the __________

142
Q

The dose for a rabbit test is __________ mL of test solution per kg

143
Q

The apparatus to be used in rabbit test is depyrogenated at ___________°C for 30 minutes

144
Q

In rabbit test, record temperature at 1,2,3 hour with an accuracy of __________°

145
Q

Solvent to be used in rabbit test

A

NSS (If NaCl is specified)

PH 112 - Pharmaceutical Analysis 2 (Lec) (10 decks)

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