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Pharmaceutical Analysis II (Lec) > Finished Product Quality Control > Flashcards

Finished Product Quality Control Flashcards

1
Q

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

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

A

25

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4
Q

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

A

6 inches

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5
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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6
Q

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

A

Swelling

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7
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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8
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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9
Q

Apparatus used in disintegration test

A

Basket-rack assembly

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10
Q

Temperature (Basket-rack assembly setting)

A

37°C +/- 2°C

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11
Q

Cycles (Basket-rack assembly setting)

A

29-32 cycles/min

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12
Q

Sample size (Basket-rack assembly setting)

A

6 tablets

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13
Q

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

A

Water - 30 mins

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14
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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15
Q

Buccal tablet (Time requirement for disintegration)

A

Water - 4 hours

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16
Q

Sublingual tablets (Time requirement for disintegration)

A

Water - 3 minutes

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17
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)

A

Dissolution test

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18
Q

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

A

Apparatus 1 (Rotating basket)

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19
Q

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

A

Apparatus 2 (Paddle assembly)

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20
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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21
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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22
Q

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

A

Apparatus 5 (Paddle over disk)

23
Q

Useful for transdermal patch (USP apparatus for dissolution test)

A

Apparatus 6 (Cylinder)

24
Q

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

A

Apparatus 7 (Reciprocating holder)

25
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

26
Q

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

A

Stage 2

27
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

28
Q

Only one sample per vessel is withdrawn; primarily used in routine quality control testing (Quality control tests)

A

Single-time point

29
Q

Multiple samples are withdrawn from the dissolution medium per vessel at pre-determined time points; primarily used as surrogate for bioequivalence studies (Quality control tests)

A

Multiple-time point

30
Q

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

A

Suspensions, Emulsions, Gels

31
Q

Applied to assure uniform potency for tablets of low dose drugs (Methods of testing uniformity of dosage units)

A

Content uniformity

32
Q

Provides an idea whether the dose in a batch of units is uniform (Methods of testing uniformity of dosage units)

A

Weight variation

33
Q

In content uniformity test, ________ dosage units are assayed individually according to the method described in the individual monograph

A

10

34
Q

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

A

30

35
Q

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

A

10

36
Q

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

A

10

37
Q

For weight variation test, the assumption is __________

A

Uniform concentration

38
Q

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

A

30

39
Q

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

A

Tablet thickness test

40
Q

Used to test if tablet has adequate strength to withstand the rigors of mechanical shocks (Quality control test)

A

Tablet hardness test

41
Q

Uses a spring applied diametrically to a heat (Hardness test equipment)

A

Stokes-Monsanto

42
Q

Uses force produces by a manually operated air pump (Hardness test equipment)

A

Strong Cobb

43
Q

Uses pliers (Hardness test equipment)

A

Pfizer

44
Q

Uses suspended motor-drive weight (Hardness test equipment)

A

Erweka

45
Q

Uses motor-driven anvil that crushed tablet horizontally (Hardness test equipment)

A

Schleuniger

46
Q

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

A

Conventional tablets

47
Q

7-10 kg (Tablet hardness)

A

Buccal tablets

48
Q

2-3 kg (Tablet hardness)

A

Chewable/SL tablets

49
Q

> 10 kg (Tablet hardness)

A

MR tablets

50
Q

Used to assess the volume of a liquid that is declared on its label (Quality control tests)

A

Deliverable volume test

51
Q

The number of samples for deliverable volume test is __________ containers

A

30

52
Q

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

A

10

53
Q

Utilizes limulus amoebocyte lysate from the horseshoe carb Limulus polyphemus; used to test for pyrogens (Quality control tests)

A

LAL test

Pharmaceutical Analysis II (Lec) (8 decks)

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