IV. IN PROCESS QUALITY CONTROL (IPQC) (copy)

Particle Size Distribution

Density

Flowability

Moisture Content

Percentage Fines

IPQC for powders and granules (5)

d. Sieving

[IPQC TESTS FOR POWDERS & GRANULES]

The particle size distribution analysis method that is official and fastest

a. Microscopy
b. Laser Diffraction
c. Sedimentation
d. Sieving

c. Official and fastest

[IPQC TESTS FOR POWDERS & GRANULES]

The characteristic of Sieving as a method of particle size distribution analysis

a. Most accurate and slowest
b. Unofficial and fastest
c. Official and fastest
d. Official and most accurate

d. Optical Microscopy

[IPQC TESTS FOR POWDERS & GRANULES]

The particle size distribution analysis method that is more reliable but more tedious

a. Sieving
b. Sedimentation
c. Laser Diffraction
d. Optical Microscopy

d. Optical Microscopy

[IPQC TESTS FOR POWDERS & GRANULES]

The particle size distribution analysis method that is alternative to seiving

a. Sieving
b. Sedimentation
c. Laser Diffraction
d. Optical Microscopy

b. Sedimentation

[IPQC TESTS FOR POWDERS & GRANULES]

The particle size distribution analysis method that uses Andreasen apparatus

a. Sieving
b. Sedimentation
c. Laser Diffraction
d. Optical Microscopy

d. Set of sieves with varying sieve number

[IPQC TESTS FOR POWDERS & GRANULES]

The apparatus used in Sieving for particle size distribution analysis

a. Optical microscope and polarimeter
b. Laser diffractometer
c. Pycnometer and hydrometer
d. Set of sieves with varying sieve number

c. ≥ 25g

[IPQC TESTS FOR POWDERS & GRANULES]

The minimum sample size needed in Sieving due to particle attrition

a. ≥ 10g
b. ≥ 50g
c. ≥ 25g
d. ≥ 5g

a. Oily and cohesive materials

[IPQC TESTS FOR POWDERS & GRANULES]

The types of materials for which Sieving is not applicable

a. Oily and cohesive materials
b. Dry and powdered materials
c. Crystalline and amorphous materials
d. Large and coarse materials

d. Mechanical Agitation

[IPQC TESTS FOR POWDERS & GRANULES]

The sieving method that uses a sieve shaker

a. Air Entrainment
b. Air Jet Sieving
c. Wet Sieving
d. Mechanical Agitation

d. Mechanical Agitation

[IPQC TESTS FOR POWDERS & GRANULES]

The sieving method also known as dry sieving

a. Air Entrainment
b. Air Jet Sieving
c. Wet Sieving
d. Mechanical Agitation

[IPQC TESTS FOR POWDERS & GRANULES]

The particle size for which Mechanical Agitation or dry sieving is used

a. > 75 μm
b. < 50 μm
c. > 100 μm
d. < 75 μm

c. Air Entrainment

[IPQC TESTS FOR POWDERS & GRANULES]

The sieving method used for smaller particle sizes

a. Mechanical Agitation
b. Dry Sieving
c. Air Entrainment
d. Sieve Shaker Method

b. Sonic sifter sieving &
d. Air Jet Sieving

[IPQC TESTS FOR POWDERS & GRANULES]

Examples of the Air Entrainment sieving method

a. Sieve Shaker
b. Sonic sifter sieving
c. Mechanical Agitation
d. Air Jet Sieving

1. Stack the sieves on top of one another in ascending degrees of coarseness.

2. Place the sample on the top sieve.

3. Subject the nest of sieves to agitation (5 Mins)

4. Weigh the material retained on each sieve. = weight 1

5. Re-assemble, agitate, and weigh again. = weight 2

am

[IPQC TESTS FOR POWDERS & GRANULES]

ARRANGE Analytical Sieving Procedure:

• Subject the nest of sieves to agitation.

• Re-assemble, agitate, and weigh again.

• Weigh the material retained on each sieve.

• Place the sample on the top sieve.

• Stack the sieves on top of one another in ascending degrees of coarseness.

a. The weight change is NMT 5%

[IPQC TESTS FOR POWDERS & GRANULES]

The endpoint criterion for Analytical Sieving

a. The weight change is NMT 5%
b. The weight change is NMT 10%
c. The weight change is NLT 5%
d. The weight change is NLT 10%

d. %WC = (initial wt − final wt) / initial wt × 100

[IPQC TESTS FOR POWDERS & GRANULES]

The formula used to calculate the percent weight change in Analytical Sieving

a. %WC = (final wt − initial wt) / final wt × 100
b. %WC = (initial wt − final wt) / final wt × 100
c. %WC = (final wt − initial wt) / initial wt × 100
d. %WC = (initial wt − final wt) / initial wt × 100

d. NMT 20%

[IPQC TESTS FOR POWDERS & GRANULES]

The allowable percent weight change when less than 5% of the sample weight is present on a sieve

a. NMT 5%
b. NMT 10%
c. NMT 25%
d. NMT 20%

c. If < 5% of the sample weight is present on a sieve

[IPQC TESTS FOR POWDERS & GRANULES]

The condition under which the %WC limit is relaxed to NMT 20% in Analytical Sieving

a. If > 5% of the sample weight is present on a sieve
b. If < 10% of the sample weight is present on a sieve
c. If < 5% of the sample weight is present on a sieve
d. If > 10% of the sample weight is present on a sieve

c. Density

[IPQC TESTS FOR POWDERS & GRANULES]

The powder property that affects compressibility, tablet porosity, and dissolution

a. Particle Size
b. Flow Rate
c. Density
d. Moisture Content

d. g/mL or g/cm³

[IPQC TESTS FOR POWDERS & GRANULES]

The units used to express Bulk Density

a. g/L or mg/mL
b. kg/m³ or lb/ft³
c. mg/g or μg/mL
d. g/mL or g/cm³

c. Bulk Density

[IPQC TESTS FOR POWDERS & GRANULES]

The ratio of the mass of an untapped powder sample and its volume

a. Tapped Density
b. True Density
c. Bulk Density
d. Apparent Density

d. Bulk Density

[IPQC TESTS FOR POWDERS & GRANULES]

The most common type of density measurement for powder samples

a. True Density
b. Tapped Density
c. Apparent Density
d. Bulk Density

• unit: g/mL

• V untapped = powders + spaces

[IPQC TESTS FOR POWDERS & GRANULES]

p 𝒃𝒖𝒍𝒌 =

c. Graduated cylinder (250 mL)

[IPQC TESTS FOR POWDERS & GRANULES]

The apparatus used in Method I of Bulk Density determination

a. Scott Volumeter
b. Stainless steel cylinder vessel
c. Graduated cylinder (250 mL)
d. Pycnomete

a. n = 100g of powder or granules

[IPQC TESTS FOR POWDERS & GRANULES]

The sample size used in Method I of Bulk Density determination

a. n = 100g of powder or granules
b. n = 200g of powder or granules
c. n = 150g of powder or granules
d. n = 1000g of powder or granules

d. Scott Volumeter (250 mL graduated cylinder)

[IPQC TESTS FOR POWDERS & GRANULES]

a. Pycnometer
b. Stainless steel cylinder vessel
c. Graduated cylinder (100 mL)
d. Scott Volumeter (25 mL graduated cylinder)

b. 100 mL Stainless steel cylinder vessel

[IPQC TESTS FOR POWDERS & GRANULES]

The apparatus used in Method III of Bulk Density determination

a. Pycnometer
b. 100 mL Stainless steel cylinder vessel
c. Graduated cylinder (100 mL)
d. Scott Volumeter (25 mL graduated cylinder)

c. Tapped Density

[IPQC TESTS FOR POWDERS & GRANULES]

An increased bulk density attained after tapping the sample

a. True Density
b. Bulk Density
c. Tapped Density
d. Apparent Density

b. ρtapped = weight in grams / Vtapped in mL

[IPQC TESTS FOR POWDERS & GRANULES]

The formula used to calculate Tapped Density

a. ρtapped = Vtapped in mL / weight in grams
b. ρtapped = weight in grams / Vtapped in mL
c. ρtapped = weight in grams / Vbulk in mL
d. ρtapped = Vbulk in mL / weight in grams

a. Graduated cylinder

[IPQC TESTS FOR POWDERS & GRANULES]

The apparatus used in Method I and II of Tapped Density determination

a. Graduated cylinder
b. Stainless steel cylinder vessel
c. Pycnometer
d. Scott Volumeter

d. Tap 10 times

[IPQC TESTS FOR POWDERS & GRANULES]

The first tapping step in Method I and II of Tapped Density determination

a. Tap 500 times
b. Tap 1250 times
c. Tap 100 times
d. Tap 10 times

a. Tap 500 times

[IPQC TESTS FOR POWDERS & GRANULES]

The second tapping step in Method I and II of Tapped Density determination

a. Tap 500 times
b. Tap 1250 times
c. Tap 100 times
d. Tap 10 times

b. Tap 1250 times

[IPQC TESTS FOR POWDERS & GRANULES]

The third and final tapping step in Method I and II of Tapped Density determination

a. Tap 500 times
b. Tap 1250 times
c. Tap 100 times
d. Tap 10 times

c. If V500 − V1250 ≤ 2 mL

• V1250 is tapped volume

• if > 2 mL = tap 2500, V2500 is tapped volume

• and so on +1250

[IPQC TESTS FOR POWDERS & GRANULES]

The condition under which V1250 is accepted as the tapped volume

a. If V500 − V1250 ≥ 2 mL
b. If V10 − V500 ≤ 2 mL
c. If V500 − V1250 ≤ 2 mL
d. If V10 − V1250 ≤ 2 mL

b. Vessel

[IPQC TESTS FOR POWDERS & GRANULES]

The apparatus used in Method III of Tapped Density determination

a. Graduated cylinder
b. Vessel
c. Pycnometer
d. Scott Volumeter

d. 200 taps

[IPQC TESTS FOR POWDERS & GRANULES]

The number of initial taps performed in Method III (Vessel) of Tapped Density determination

a. 10 taps
b. 500 taps
c. 1250 taps
d. 200 taps

a. 400 taps

[IPQC TESTS FOR POWDERS & GRANULES]

The number of subsequent taps performed in Method III (Vessel) of Tapped Density determination

a. 400 taps
b. 1250 taps
c. 500 taps
d. 200 taps

d. Method III

[IPQC TESTS FOR POWDERS & GRANULES]

The method of Tapped Density determination that uses tapping steps of 200 to 400 taps

a. Method I
b. Method IV
c. Method II
d. Method III

b. Angle of Repose

[IPQC TESTS FOR POWDERS & GRANULES]

The constant 3D angle relative to the horizontal base assumed by a cone-like pile of material

a. Angle of Inclination
b. Angle of Repose
c. Angle of Friction
d. Angle of Contact

c. ϴ

• soh cah toa

[IPQC TESTS FOR POWDERS & GRANULES]

The symbol used to represent the Angle of Repose

a. α
b. φ
c. ϴ
d. β

c. Fixed Funnel

[IPQC TESTS FOR POWDERS & GRANULES]

The official USP method used to determine the Angle of Repose

a. Tilting box
b. Revolving cylinder
c. Fixed Funnel
d. Sieve shaker

a. Funnel, tilting box, and revolving cylinder

[IPQC TESTS FOR POWDERS & GRANULES]

The methods used to determine the Angle of Repose

a. Fixed Funnel, tilting box, and revolving cylinder
b. Funnel, pycnometer, and sieve shaker
c. Scott volumeter, tilting box, and funnel
d. Revolving cylinder, sieve shaker, and pycnometer

Where:

• h = height of the powder of the cone

• r = radius of the powder cone

[IPQC TESTS FOR POWDERS & GRANULES]

Angle of repose formula

c. Compressibility Index

[IPQC TESTS FOR POWDERS & GRANULES]

A measure of a powder's compressibility

a. Angle of Repose
b. Bulk Density
c. Compressibility Index
d. Tapped Density

c. Carr's Index and Hausner Ratio

[IPQC TESTS FOR POWDERS & GRANULES]

The Compressibility Index is also known as

a. Bulk Index and Tapped Ratio
b. Powder Flow Index and Density Ratio
c. Carr's Index and Hausner Ratio
d. Angle Index and Flow Ratio

c. Same with Method I of bulk and tapped density

[IPQC TESTS FOR POWDERS & GRANULES]

The method used in the determination of Compressibility Index

a. Same with Method II of bulk and tapped density
b. Same with Method III of bulk and tapped density
c. Same with Method I of bulk and tapped density
d. Same with Method IV of bulk and tapped density

d. Graduated cylinder (250 mL)

[IPQC TESTS FOR POWDERS & GRANULES]

The apparatus used in the determination of Compressibility Index based on its method

a. Scott Volumeter
b. Stainless steel cylinder vessel
c. Pycnometer
d. Graduated cylinder (250 mL)

• always >1

• HR is unitless

[IPQC TESTS FOR POWDERS & GRANULES]

CI=

HR=

c. Flowability

[IPQC TESTS FOR POWDERS & GRANULES]

The powder property that affects the ability of granules to transfer from the hopper to the die cavity for tablet uniformity

a. Moisture Content
b. Particle Size
c. Flowability
d. Compressibility

Angle of Repose

Compressibility Index

Flow through an Orifice

Shear Cell

[IPQC TESTS FOR POWDERS & GRANULES]

The methods used to determine Flowability (4)

b. Required for the binding of the powder or granules during compression in die cavity

[IPQC TESTS FOR POWDERS & GRANULES]

The role of Moisture Content in tablet manufacturing

a. Required for the coating of the tablet
b. Required for the binding of the powder or granules during compression in die cavity
c. Required for the dissolution of the API
d. Required for the disintegration of the tablet

d. Gravimetry (IR moisture balance)

[IPQC TESTS FOR POWDERS & GRANULES]

The method used to determine Moisture Content of granules

a. Sieving
b. Karl Fischer Titrimetry
c. Azeotropic Method
d. Gravimetry (IR moisture balance)

c. Percentage Fines

[IPQC TESTS FOR POWDERS & GRANULES]

The amount of powders remaining in the granulation

a. Moisture Content
b. Compressibility Index
c. Percentage Fines
d. Flowability

d. Sieving

[IPQC TESTS FOR POWDERS & GRANULES]

The method used to determine Percentage Fines

a. Gravimetry
b. Microscopy
c. Karl Fischer Titrimetry
d. Sieving

a. 0.5%-1%

[IPQC TESTS FOR POWDERS & GRANULES]

Moisture content generally contains ___% moisture

a. 0.5%-1%
b. 20%-25%
c. 5%-10%
d. 10%-15%

d. Flow Through an Orifice

[IPQC TESTS FOR POWDERS & GRANULES]

The flowability method that measures mass per time flowing through a container

a. Angle of Repose
b. Shear Cell
c. Compressibility Index
d. Flow Through an Orifice

b. g/sec or kg/min

[IPQC TESTS FOR POWDERS & GRANULES]

The units used to express flow rate in the Flow Through an Orifice method

a. mL/min or L/sec
b. g/sec or kg/min
c. mg/min or g/hr
d. cm³/sec or mL/min

c. Cylinders, funnels, and hoppers

[IPQC TESTS FOR POWDERS & GRANULES]

The containers used in the Flow Through an Orifice method

a. Petri dishes, beakers, and flasks
b. Graduated cylinders, pycnometers, and funnels
c. Cylinders, funnels, and hoppers
d. Test tubes, cylinders, and hoppers

d. Free-flowing powders only

[IPQC TESTS FOR POWDERS & GRANULES]

The type of powder for which the Flow Through an Orifice method is applicable

a. Cohesive powders only
b. Oily powders only
c. All powder types
d. Free-flowing powders only

• Tablet Breaking Force

• Tablet Thickness

• Tablet Weight Variation

IPQC TESTS FOR TABLETS (3)

c. Tablet Hardness

• or Breaking Force or Crushing Strength

[IPQC TESTS FOR TABLETS]

The measure of a tablet's resistance to mechanical shocks

a. Friability
b. Disintegration
c. Tablet Hardness
d. Dissolution

b. Tablet Hardness and Crushing Strength

[IPQC TESTS FOR TABLETS]

The other names for Tablet Breaking Force

a. Tablet Durability and Crushing Strength

c. Friability and Crushing Strength
d. Tablet Hardness and Friability

d. kg

[IPQC TESTS FOR TABLETS]

The unit used to measure Tablet Breaking Force

a. Newton (N)
b. Pascal (Pa)
c. mg
d. kg

c. Harder tablets have slower disintegration and dissolution

[IPQC TESTS FOR TABLETS]

The relationship between tablet hardness and disintegration/dissolution

a. Harder tablets have faster disintegration and dissolution
b. Hardness has no effect on disintegration and dissolution
c. Harder tablets have slower disintegration and dissolution
d. Softer tablets have slower disintegration and dissolution

d. 4–10 kg

[IPQC TESTS FOR TABLETS]

The acceptable Tablet Breaking Force for compressed tablets

a. 2–3 kg
b. 10–20 kg
c. 7–10 kg
d. 4–10 kg

c. 7–10 kg

[IPQC TESTS FOR TABLETS]

The acceptable Tablet Breaking Force for Buccal tablets

a. 2–3 kg
b. 10–20 kg
c. 7–10 kg
d. 4–10 kg

a. 2–3 kg

[IPQC TESTS FOR TABLETS]

The acceptable Tablet Breaking Force for Chewable and Sublingual tablets

a. 2–3 kg
b. 10–20 kg
c. 7–10 kg
d. 4–10 kg

b. 10–20 kg

[IPQC TESTS FOR TABLETS]

The acceptable Tablet Breaking Force for Sustained Release tablets

a. 2–3 kg
b. 10–20 kg
c. 7–10 kg
d. 4–10 kg

d. Sustained Release tablets

Acceptance Criteria:

✓ Compressed tab – 4-10 kg

✓ Buccal tab – 7-10 kg

✓ Chewable / sublingual – 2-3 kg

✓ Sustained release – 10-20 kg

[IPQC TESTS FOR TABLETS]

The tablet type with the highest acceptable Tablet Breaking Force

a. Compressed tablets
b. Buccal tablets
c. Chewable tablets
d. Sustained Release tablets

a. NLT 6 units

[IPQC TESTS FOR TABLETS]

The minimum sample size used in the Tablet Breaking Force test

a. NLT 6 units
b. NLT 20 units
c. NLT 3 units
d. NLT 8 units

d. Rule of Thumb

[IPQC TESTS FOR TABLETS]

The hardness tester that uses a crude method described as a sharp snap

a. Monsanto
b. Strong-Cobb
c. Pfizer
d. Rule of Thumb

a. Stokes Monsanto

[IPQC TESTS FOR TABLETS]

The hardness tester that uses a spring mechanism

a. Stokes Monsanto
b. Strong-Cobb
c. Pfizer
d. Rule of Thumb

b. Strong-Cobb

[IPQC TESTS FOR TABLETS]

The hardness tester that uses air pump or hydraulic pressure

a. Stokes Monsanto
b. Strong-Cobb
c. Pfizer
d. Rule of Thumb

d. Pfizer

[IPQC TESTS FOR TABLETS]

The hardness tester that operates like pliers

a. Erweka
b. Strong-Cobb
c. Monsanto
d. Pfizer

a. Erweka

[IPQC TESTS FOR TABLETS]

The hardness tester that uses a suspended motor-driven weight

a. Erweka
b. Strong-Cobb
c. Monsanto
d. Pfizer

d. Schleuniger/Heberlein

[IPQC TESTS FOR TABLETS]

The hardness tester that uses a motor-driven anvil that crushes the tablet horizontally

a. Erweka
b. Pfizer
c. Strong-Cobb
d. Schleuniger/Heberlein

d. Schleuniger/Heberlein

[IPQC TESTS FOR TABLETS]

The most widely used hardness tester that eliminates operator variability

a. Monsanto
b. Erweka
c. Pfizer
d. Schleuniger/Heberlein

c. Vernier Caliper

[IPQC TESTS FOR TABLETS]

The apparatus used to measure Tablet Thickness

a. Micrometer
b. Ruler
c. Vernier Caliper
d. Hardness Tester

c. ± 5%

[IPQC TESTS FOR TABLETS]

The acceptable variation in Tablet Thickness from the set standard

a. ± 10%
b. ± 2%
c. ± 5%
d. ± 1%

a. LL = ave - (ave × var)

[IPQC TESTS FOR TABLETS]

The formula for the Lower Limit in Tablet Thickness determination

a. LL = ave - (ave × var)
b. LL = ave − (ave + var)
c. LL = ave × (1 − var)
d. LL = ave + (ave × var)

d. UL = ave + (ave × var)

[IPQC TESTS FOR TABLETS]

The formula for the Upper Limit in Tablet Thickness determination

a. UL = ave − (ave × var)
b. UL = ave + (ave + var)
c. UL = ave × (1 + var)
d. UL = ave + (ave × var)

c. Tablet Weight

[IPQC TESTS FOR TABLETS]

The tablet weight test that is unofficial under USP XX and applies to tablets containing ≥ 50 mg API

a. Content Uniformity
b. Weight Variation
c. Tablet Weight
d. Minimum Fill

a. ≥ 50 mg API

[IPQC TESTS FOR TABLETS]

The minimum API content for the Tablet Weight test to be applicable

a. ≥ 50 mg API
b. ≥ 25 mg API
c. ≥ 5 mg API
d. ≥ 500 mg API

b. ≥ 25 mg API

[IPQC TESTS FOR TABLETS]

The minimum API content for the Tablet Weight test to be applicable for new formulations

a. ≥ 50 mg API
b. ≥ 25 mg API
c. ≥ 5 mg API
d. ≥ 500 mg API

c. n = 20 units

[IPQC TESTS FOR TABLETS]

The sample size used in the Tablet Weight test

a. n = 6 units
b. n = 10 units
c. n = 20 units
d. n = 30 units

d. NMT 2 tablets

[IPQC TESTS FOR TABLETS]

The acceptance criterion for the number of tablets allowed outside the acceptable tablet weight range in the Tablet Weight test

a. NMT 1 tablet
b. NMT 3 tablets
c. NMT 5 tablets
d. NMT 2 tablets

b. No unit is outside twice the acceptable % weight variation

[IPQC TESTS FOR TABLETS]

The absolute criterion that must never be violated in the Tablet Weight test

a. NMT 2 units outside twice the acceptable % weight variation
b. No unit is outside twice the acceptable % weight variation
c. NMT 1 unit outside twice the acceptable % weight variation
d. No unit is outside the acceptable % weight variation

d. 10%

[IPQC TESTS FOR TABLETS]

The acceptable percentage weight variation for tablets with an average tablet weight of less than 130 mg

a. 5%
b. 7.5%
c. 15%
d. 10%

b. 7.5%

[IPQC TESTS FOR TABLETS]

The acceptable percentage weight variation for tablets with an average tablet weight of 130–324 mg

a. 5%
b. 7.5%
c. 15%
d. 10%

a. 5%

[IPQC TESTS FOR TABLETS]

The acceptable percentage weight variation for tablets with an average tablet weight of >324 mg

a. 5%
b. 7.5%
c. 15%
d. 10%