qc lec midterm

Friability test

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

Friabilator

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

25

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

6

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

6.5

For tablets weighing = or

10

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

100

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

4

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

1.0%

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

Wicking

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

Swelling

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

Intragranular disintegrant

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

Extragranular disintegrant

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

Basket-rack assembly

Apparatus used in disintegration test

37°C ± 2°C

Temperature (Basket-rack assembly setting)

29-32 cycles/min

Cycles (Basket-rack assembly setting)

6 tablets

Sample size (Basket-rack assembly setting)

6

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

37 ± 2

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

30

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

Water - 30 mins

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

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

Enteric coated tablet (Time requirement for disintegration)

Water - 4 hours

Buccal tablet (Time requirement for disintegration)

Water - 3 minutes

Sublingual tablets (Time requirement for disintegration)

Dissolution test

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)

Apparatus 1 (Rotating basket/Basket)

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

Apparatus 2 (Paddle assembly)

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

Apparatus 3 (Reciprocating cylinder/Bio-dis)

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

Apparatus 3 (Reciprocating cylinder/Bio-dis)

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

Apparatus 3 (Reciprocating cylinder/Bio-dis)

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

Apparatus 3 (Reciprocating cylinder/Bio-dis)

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

Apparatus 4 (Flow-through cell)

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

Apparatus 5 (Paddle over disk)

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

Apparatus 6 (Revolving cylinder/Cylinder)

Useful for transdermal patch (USP apparatus for dissolution test)

Apparatus 7 (Reciprocating holder)

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

37 ± 0.5

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

HCl, Phosphate butter, Acetate buffer, Water

4 buffers to use for dissolution test (HPAW)

900 mL

Volume of buffer to be used in dissolution test

30

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)

1

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)

Stage 1

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

Stage 2

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

Stage 3

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)

Single-time point dissolution test

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

Multiple-time point dissolution test

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)

Suspensions, Emulsions, Gels

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

Content uniformity

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

Content uniformity

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

Weight variation

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

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

10

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

85-115%

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)

6%

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)

30

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

10

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

10

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

Uniform concentration

For weight variation test, the assumption is __

30

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

30

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

10

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

10

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

Tablet thickness test

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 hardness test

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

Dissolution, Disintegration, Bioavailability

Tablet hardness affects __, __, and ___ (DDB)

Stokes-Monsanto

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

Strong Cobb

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

Pfizer

Uses pliers (Tablet hardness tester)

Erweka

Uses suspended motor-drive weight (Tablet hardness tester)

Schleuniger

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

Conventional tablets

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

Buccal tablets

7-10 kg (Tablet hardness)

Chewable/SL tablets

2-3 kg (Tablet hardness)

MR tablets

10 kg (Tablet hardness)

Deliverable volume test

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

Brookfield

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

Single-unit

Deliverable volume test is not required for __ containers

30

The number of samples for deliverable volume test is __ containers

10

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

10

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

30

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)

5

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)

100

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

95

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

50

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

25

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

30

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

10

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

10

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

10

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

100

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)

95

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)

30

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

90%

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)

95%

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)

250

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

2

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

5

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

0.02

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

30

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

40

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