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
2
Q
Device that subjects a number of tablets to the combined effects of abrasion and shock; used in friability test
A
Friabilator
3
Q
A friabilator revolves at __________ rpm, dropping the tablets at a distance of 6 inches with each revolution (Settings for friabilator)
A
25
4
Q
A friabilator revolves at 25 rpm, dropping the tablets a distance of __________ inches with each revolution (Settings for friabilator)
A
6
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
6
Q
For tablets weighing >650 mg, take a sample of __________ whole tablets (Procedures for friability test)
A
10
7
Q
Rotate the drum __________ times (25 rpm for 4 minutes) (Procedures for friability test)
A
100
8
Q
Rotate the drum 100 times (25 rpm for __________ minutes) (Procedures for friability test)
A
4
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%
10
Q
Process where water is pulled into pores by the disintegrant and reduces the physical bonding forces between particles
A
Wicking
11
Q
Process where particles swell and breakup the matrix from within due to the disintegrant
A
Swelling
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
13
Q
Disintegrants that are mixed with the dry granules before the complete powder mix is compacted (Types of disintegrants)
A
Extragranular disintegrant
14
Q
Apparatus used in disintegration test
A
Basket-rack assembly
15
Q
Temperature (Basket-rack assembly setting)
A
37°C ± 2°C
16
Q
Cycles (Basket-rack assembly setting)
A
29-32 cycles/min
17
Q
Sample size (Basket-rack assembly setting)
A
6 tablets
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
19
Q
Operate the apparatus using water maintained at ___________°C, as the immersion fluid (Procedures for disintegration test)
A
37 ± 2
20
Q
Lift the basket from the fluid after __________ minutes and observe the tablets (Procedures for disintegration test)
A
30
21
Q
Plain, coated tablet and capsules (Time requirement for disintegration)
A
Water - 30 mins
22
Q
Enteric coated tablet (Time requirement for disintegration)
A
Water - 5 minutes soaking
Simulated gastric juice - 1 hour
Simulated intestinal juice - 1 hour
23
Q
Buccal tablet (Time requirement for disintegration)
A
Water - 4 hours
24
Q
Sublingual tablets (Time requirement for disintegration)
A
Water - 3 minutes
25
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)
Dissolution test
26
Useful for tablets, capsules, floaters, beads, and modified release (USP apparatus for dissolution test)
Apparatus 1 (Rotating basket/Basket)
27
Useful for tablets, modified release, and transdermal patch (USP apparatus for dissolution test)
Apparatus 2 (Paddle assembly)
28
First line apparatus in product development of controlled-release preparation (USP apparatus for dissolution test)
Apparatus 3 (Reciprocating cylinder/Bio-dis)
29
Its development was based on the need to establish IVIVC (USP apparatus for dissolution test)
Apparatus 3 (Reciprocating cylinder/Bio-dis)
30
Used for testing of products of poorly-soluble drugs (USP apparatus for dissolution test)
Apparatus 3 (Reciprocating cylinder/Bio-dis)
31
Used for modification of the USP/NF disintegration tester (USP apparatus for dissolution test)
Apparatus 3 (Reciprocating cylinder/Bio-dis)
32
Useful for low solubility drugs, rapid degradation, and media pH change (USP apparatus for dissolution test)
Apparatus 4 (Flow-through cell)
33
Useful for transdermal patch, ointments, floaters, emulsions, and bolus (USP apparatus for dissolution test)
Apparatus 5 (Paddle over disk)
34
Useful for transdermal patch (USP apparatus for dissolution test)
Apparatus 6 (Revolving cylinder/Cylinder)
35
Useful for transdermal patch, solid dosage forms, pH profile, and small volume (USP apparatus for dissolution test)
Apparatus 7 (Reciprocating holder)
36
Assemble the apparatus and equilibrate the dissolution medium to __________°C (Procedures for dissolution test)
37 ± 0.5
37
4 buffers to use for dissolution test (HPAW)
HCl, Phosphate butter, Acetate buffer, Water
38
Volume of buffer to be used in dissolution test
900 mL
39
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)
30
40
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)
1
41
Sample is 6; All units should have dissolved NLT Q+5%; Q-tolerance is specified in the monograph (Dissolution test stages)
Stage 1
42
Sample is +6; Average number of units NLT Q; No unit less than Q-15% (Dissolution test stages)
Stage 2
43
Sample is +12; Average of 24 units should not be less than Q; NMT 2 units
Stage 3
44
Only one sample per vessel is withdrawn (usually after 30 minutes); primarily used in routine quality control testing (Types of dissolution test)
Single-time point dissolution test
45
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)
Multiple-time point dissolution test
46
Uniformity of dosage units are not intended for __________, __________, and __________ (SEG)
Suspensions, Emulsions, Gels
47
Based on the assay of the individual content of drug substances (Quality control tests for tablets and capsules - uniformity of dosage units)
Content uniformity
48
Applied to assure uniform potency for tablets of low dose drugs (Quality control tests for tablets and capsules - uniformity of dosage units)
Content uniformity
49
Provides an idea whether the dose in a batch of units is uniform (Quality control tests for tablets and capsules - uniformity of dosage units)
Weight variation
50
Applied when the dosage form consists of 90-95% of the active ingredient (Quality control tests for tablets and capsules - uniformity of dosage units)
Weight variation
51
________ dosage units are assayed individually according to the method described in the individual monograph (Content uniformity test)
10
52
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)
85-115%
53
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)
6%
54
The number of required sample in content uniformity test is __________ units
30
55
When conducting content uniformity test, one must assay __________ units of solid dosage forms individually
10
56
When conducting content uniformity test, one must assay __________ units of liquid or semi-solid dosage forms individually
10
57
For weight variation test, the assumption is __________
Uniform concentration
58
The number of samples for weight variation test is __________ dosage units of uncoated or film-coated tablets and hard capsules
30
59
Select not fewer than __________ dosage units, and proceed as follows for the dosage form designated (Procedures for weight variation test - tablets)
30
60
Accurately weigh __________ tablets individually (Procedures for weight variation test - tablets)
10
61
Accurately weigh __________ capsules individually (Procedures for weight variation test - hard capsules)
10
62
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)
Tablet thickness test
63
Used to test if tablet has adequate strength to withstand the rigors of mechanical shocks (Quality control tests for tablets and capsules)
Tablet hardness test
64
Tablet hardness affects __________, __________, and ___________ (DDB)
Dissolution, Disintegration, Bioavailability
65
Uses a spring applied diametrically to a heat (Tablet hardness tester)
Stokes-Monsanto
66
Uses force produced by a manually operated air pump (Tablet hardness tester)
Strong Cobb
67
Uses pliers (Tablet hardness tester)
Pfizer
68
Uses suspended motor-drive weight (Tablet hardness tester)
Erweka
69
Uses motor-driven anvil that crushed tablet horizontally (Tablet hardness tester)
Schleuniger
70
4 kg (4-10 kg) (Tablet hardness)
Conventional tablets
71
7-10 kg (Tablet hardness)
Buccal tablets
72
2-3 kg (Tablet hardness)
Chewable/SL tablets
73
>10 kg (Tablet hardness)
MR tablets
74
Used to assess the volume of a liquid that is declared on its label (Quality control tests for liquids and semi-solids)
Deliverable volume test
75
Deliverable volume test assesses the viscosity of a suspension by using a __________ viscometer
Brookfield
76
Deliverable volume test is not required for __________ containers
Single-unit
77
The number of samples for deliverable volume test is __________ containers
30
78
The number of samples for minimum fill test is __________ filled containers
10
79
Shake the contents of __________ containers individually (Procedures for deliverable volume test)
10
80
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)
30
81
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)
5
82
The average volume of 10 containers must be NLT __________% (Acceptance criteria for deliverable volume test)
100
83
There must be no container that has a volume less than ___________% of the volume declared in the labeling (Acceptance criteria for deliverable volume test)
95
84
Tare a 100 mL volumetric flask containing __________ mL of water (Procedures for deliverable volume test)
50
85
Add approximately __________ g of well-shaken product and gently swirl the contents to mix (Procedure for deliverable volume test)
25
86
Select not less than __________ containers (Procedure for deliverable volume test)
30
87
Shake the contents of __________ containers individually (Procedure for deliverable volume test)
10
88
Discharge the container contents into a suitable tared container in not more than __________ minutes (Procedure for deliverable volume test)
10
89
Allow each container to drain for a period not to exceed __________ minutes (Procedure for deliverable volume test)
10
90
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)
100
91
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)
95
92
The average content of __________ containers is NLT the labeled amount (Acceptance criteria for minimum fill test)
30
93
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)
90%
94
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%
95
Deliverable volume test is applicable to products labelled to contain NMT __________ mL
250
96
Pour __________ mL of the emulsion into a test tube (Procedures for dilution test)
2
97
Add __________ mL of purified water (Procedures for dilution test)
5
98
Dissolve a __________ g of a water-soluble dye with purified water (Procedures for dye test)
0.02
99
Allow the mixture to dry for __________ minutes (Procedures for dye test)
30
100
Observe the specimen using a microscope with a __________x magnification (Procedures for dilution test)
40
101
Pour __________ mL of the emulsion in a watch glass (Procedures for fluorescence test)
2
102
Place the emulsion under UV light in _________ and __________ nm wavelengths (Procedures for conductivity test)
254-360
103
Amaranth green - Visible result (Summary of results for emulsion tests)
Green
104
Amaranth green - Type of emulsion (Summary of results for emulsion tests)
O/W
105
Sudan red - Visible result (Summary of results for emulsion tests)
W/O
106
H2O - Visible results (Summary of results for emulsion tests)
Miscible, Immiscible
107
H2O; Miscible - Type of emulsion (Summary of results for emulsion tests)
O/W
108
H2O; Immiscible - Type of emulsion (Summary of results for emulsion tests)
W/O
109
+CoCl2 - Visible results (Summary of results for emulsion tests)
Blue (NVR), Blue → Pink
110
+CoCl2 - Blue (NVR) (Summary of results for emulsion tests)
W/O
111
+CoCl2 - Blue → Pink (Summary of results for emulsion tests)
O/W
112
UV absorption - Visible result (Summary of results for emulsion tests)
(+)
113
UV absorption - Type of emulsion (Summary of results for emulsion tests)
W/O
114
Creaming - Visible results (Summary of results for emulsion tests)
Upward, Downward
115
Creaming; Upward - Type of emulsion (Summary of results for emulsion tests)
O/W
116
Creaming; Downward - Type of emulsion (Summary of results for emulsion tests)
W/O
117
Prepare __________ mL of a 1.0% methylene blue (Procedures for Leaker's test)
500
118
Remove the label of __________ ampules (Procedures for Leaker's test)
10
119
Operate the autoclave at __________°C, __________ psi for __________ minutes (Procedures for Leaker's test)
120; 20; 15
120
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)
40
121
Protein obtained from the horseshoe crab, Limulus polyphemus; used in LAL test
Limulus amoebocyte lysate
122
LAL is obtained from the horsehoe crab (SN: __________)
Limulus polyphemus
123
Coagulation (formation of gel clot) in LAL test indicates the presence of __________
Pyrogens
124
Sample is 3; Individual T-rise should be NMT 0.5°C (Rabbit test acceptance criteria)
Stage 1
125
NMT 3/8 units will have >0.5°C; Total rise should not be >3.3°C (Rabbit test acceptance criteria)
Stage 2
126
Device used in tablet thickness test
Vernier caliper
127
A filter paper soaked in cobaltous chloride turns __________ in O/W emulsions but remains __________ in W/O emulsions
Pink; Blue
128
A water-soluble dye colors __________ emulsions
O/W
129
An oil-soluble dye colors __________ emulsions
W/O
130
When exposed to UV light, __________ emulsions glow
W/O
131
__________ emulsions conduct electricity
O/W
132
The test is carried out in a __________ (Procedures for particulate matter test - subvisible)
Laminar flow cabinet
133
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)
25
134
Average number of particles ≥10 μm does not exceed 12 per mL (Acceptance criteria for particulate matter test - type of container)
Containers w/ >100 mL
135
Average number of particles ≥25 μm does not exceed 2 per mL (Acceptance criteria for particulate matter test - type of container)
Containers w/ >100 mL
136
Average number of particles present in the units tested does not exceed 3000 per container (Acceptance criteria for particulate matter test - type of container)
Containers w/ ≥100 mL
137
Average number of particles present in the units tested does not exceed 300 per container (Acceptance criteria for particulate matter test - type of container)
Containers w/ ≥100 mL
138
3 healthy and mature rabbits are warmed to __________ prior to injection (Rabbit test)
37 ± 0.2°C
139
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)
48
140
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)
39.8
141
In rabbit test, the dose is injected in the __________
Ear vein
142
The dose for a rabbit test is __________ mL of test solution per kg
10
143
The apparatus to be used in rabbit test is depyrogenated at ___________°C for 30 minutes
250
144
In rabbit test, record temperature at 1,2,3 hour with an accuracy of __________°
+0.1
145
Solvent to be used in rabbit test
NSS (If NaCl is specified)
