BP Testing

Question 1

Give 6
examples of pharmacopoeial quality control
tests for tablets

Answer 1

1) Uniformity of weight (mass)
2) Uniformity of content
3) Disintergration test
4) Dissolution test
5) Resistance to crushing of tablets
6) Friability

Question 2

Describe the procedure for Uniformity of weight (mass)

Answer 2

1) Weigh 20 tablets, selected at random and determine the average weight
2) PASS: If no more than two individual weights deviate from the average weight by a certain percentage (and No tablets should deviate more than twice that %)

Question 3

STATEMENT: If the average weight of tablet (mg) is <80, no more than 2 tablet weights should deviate by +/- 10%.

Answer 3

TRUE

Question 4

STATEMENT: If the average weight of tablet (mg) is 80-250, no more than 2 tablet weights should deviate by +/- 7.5%.

Answer 4

TRUE

Question 5

STATEMENT: If the average weight of tablet is >250 mg, no more than 2 tablet weights should deviate by +/- 5%.

Answer 5

TRUE

Question 6

Describe the procedure of Uniformity of content

Answer 6

1) Determine the active ingredient content of 10 tablets (taken at random) w/suitable analytical method
2) PASS: If ALL 10 tablets are within the range 85-115% of the average tablet dose

FAIL: If >1 tablet dose falls outside 85-115%

3) If only 1 tablet is outside the 85-115% limit BUT within the 75-125% of the average tablet dose; repeat procedure using 20 tablets taken at random
4) In the total of 30 tablets, if no more than 1 value is outside the 85-115% and no tablet is outside the 75-125% of average tablet dose = PASS

Question 7

What is the difference b/wn disintegration and dissolution ?

Answer 7

Dissolution = Process where drug molecule moves from solid to liquid phase

Disintegration = Reduction of drug molecules to small granules

Question 8

Describe the procedure for Disintegration testing

Answer 8

1) 6 tablets (take at random) are placed individually in a tube. This is repeated three times therefore 18 tablets needed. (May need more if FAIL)
2) The tubes are vertically raised and lowered 50-60mm, 28-32 times per min. In a water bath at 37oC, using the appropriate media.
3) PASS: If ALL 18 tablets completely disintegrate within the specified time

FAIL: If any tablet has not disintegrated

Question 9

Describe the tube used in the disintegration test procedure

Answer 9

2.8 cm diameter tubes w/ 1700 micrometer sieves at the base

Question 10

What is the specified time UNCOATED TABLETS should disintegrate by ? and state the appropriate media.

Answer 10

<15 mins, Water

Question 11

What is the specified time COATED TABLETS (film) should disintegrate by? and state the appropriate media

Answer 11

<30 mins, Water

Question 12

What is the specified time ‘OTHER COATED TABLETS’ should disintegrate by? and state the appropriate media

Answer 12

<60 mins, Water.

If no disintegration occurs, then repeat test on further 6 tablets; REPLACE WATER by 0.1M HCl

Question 13

What is the specified time ‘ENTERIC COATING TABLETS’ should disintegrate by? and state the appropriate media

Answer 13

> 120 mins using 0.1M HCl, no disintegration ?

<60 mins using pH 6.8 phosphate buffer

Question 14

What is the specified time ‘EFFERVESCENT SOLUBLE TABLETS’ should disintegrate by? and state the appropriate media

Answer 14

<5 mins; 200ml water at 20oC

< 3 mins; Water at 20oC

Question 15

What is the specified time ‘DISPERSIBLE TABLETS’ should disintegrate by? and state the appropriate media

Answer 15

<3 mins; Place 2 tablets in 100ml Water at 20oC and stir until completely dispersed.

• Smooth dispersion is produced which passes through a sieve screen

Question 16

State 3 factors affecting Dissolution

Answer 16

1) Solubility of drug substance
(affected by: Composition and Temp of media)

2) Stirring (more stirring = quicker dissolution)
3) Sink conditions (normally the conc of drug in the bulk of dissolution media shouldn’t exceed 10% of solubility)

Question 17

Describe Dissolution test procedure

Answer 17

1) Individually place 3-6 tablets into dissolution beaker containing 900ml buffer (36.5 - 37.5oC).
2) Rotate paddle and basket

3) Withdraw samples at 45 mins, prescribed intervals or continuously
- Sample should be taken from a point halfway b/wn surface and top of paddle (no less than 10mm from vessel wall)

4) Determine amount of active ingredient in the sample. PASS: If >70% has dissolved by 45 mins

If one fails (>70% doesn’t dissolve in 45 mins), further 6 tablets may be tested.