The document discusses various tests conducted on tablets to check their quality, including their shape and appearance, uniformity of active ingredient content, disintegration time, dissolution rate, mechanical strength and friability. It provides details of the methodology, acceptance criteria and equipment used for tests like content uniformity, disintegration, dissolution, hardness and friability testing of tablets.

1. Rahul Dev
SMCP MOHNA

3.  SHAPE OF TABLETS
 APPEARANCE
 CONTENT OF ACTIVE INGREDIENT
 UNIFORMITY OF DOSE
 DISINTEGRATION TEST
 DISSOLUTION TEST
 MECHANICAL STRENGTH
 FRIBILITY TEST

4. 1.CIRCULAR
- FLAT
- BICONVEX
2. OVAL, BICONVEX
3. ELONGATED, BICONVEX
4 . SPECIAL SHAPES
- STAR SHAPE
- ALMOND SHAPE
- HEXAGONAL SHAPE

5. 1. UNCOATED TABLETS (BROKEN SECTION)
- SINGLE- LAYER TABLET
- MULTI-LAYERED TABLETS
THERE SHOULD BE NO SIGN OF COATING
2. COATED TABLETS
SMOOTH AND OFTEN COLOURED SURFACE

6.  DETERMINED BY ASSAY AS STATED IN
MONOGRAPH
1. 20 TABLETS ARE TAKEN
2. ASSAY IS DONE AS PER MONOGRAPH
3. TABLETS PASS THE TEST IF RESULT LIES
WITHIN LIMITS (90-110%) AS PER
MONOGRAPH
IF 20 TABLETS CAN NOT BE OBTAINED ,
LIMITS ARE RELAXED

8.  IT IS DESIREABLE THAT TABLETS SHOULD BE
UNFORM IN WEIGHT,BUT SMALL VARIATIONS ARE
LIABLE TO OCCUR.
METHOD
1. 20 TABLETS ARE SELECTED RANDOMLY ARE
WEIGHED
2. DETERMINE THEIR AVERAGE WEIGHT
CONDITION
NOT MORE THAN 2 WEIGTS MAY DEVIATE FROM
THE AVERAGE WEIGHT BY MORE THAN THE
PERCENTAGE DEVIATION GIVEN IN THE TABLE
AND NONE SHOULD DEVIATE BY MORE THAN
TWICE THAT PERCENTAGE

9. S.NO AVG. WEIGHT OF TABLET PERCENTAGE TWICE
PERCENTAGE
1 80 mg or less 10 20
2 81- 249 mg 7.5 15
3 250 mg or more 5 10

10.  DISINTEGRATION MEANS TO BREAK THE TABLET
INTO SMALLER PARTICLES AFTER SWALLOWING.
 THE TIME REQUIRED TO DISINTEGRATE THE
TABLET IS CALLED IS CALLED DISINTEGRATION
TIME

11.  IT CONTAINS A RIGID BASKET-RACK ASSEMBLY
SUPPORTING 6 CYLINDRICAL TUBES
 TUBES ARE HELD VERTICALLY BY TWO TRANSPARENT
PLASTIC PLATES
 WOVEN WIRE GAUZE MADE FROM STAINLESS STEEL IS
ATTACHED TO THE UNDERSIDE OF LOWER PLATE
 UPPER AND LOWER PLATE ARE HELD BY VERTICAL
METAL ROD AT THE PERIPHERY
 A METAL ROD IN CENTRE OF UPPER PLATE FOR
ATTACHMENT TO MECHANICAL DEVICE
 CYLINDRICAL DISC MADE OF TRANSPARENT
PLASTIC.THICKNESS- 9.5 mm , DIAMETER- 20.7 mm.
 A BEAKER 1000 ml.

12.  1.PLACE ONE TABLET IN EACH OF 6 TUBES
 2. ADD DISC TO EACH TUBE
 3. MAINTAIN TEMP. 37± 2 ºC
 4. LIFT THE BASKET AFTER 15 MINUTES.
TABLETS PLACED OBSERVATION RESULR
6 ALL TABLET
DISINTEGRATE
1-2 TABLETS FAIL
PASS
REPEAT TEST ON 12
TABS
12 16 OR MORE TABS
DISINTEGRATE
LESS THAN 16 TAB
DISINTEGRATE
PASS
FAIL

13.  1. PLACE ONE TABLET IN EACH OF 6 TUBES
 2. IMMERSE THE BASKET IN WATER FOR 5 MINUTES
 3. ADD DISC TO EACH TUBE
 4. MAINTAIN TEMP. 37± 2 ºc
TABLETS,MEDIUM &
TIME
TIME & OBSERVATION RESULT
6 TAB IN WATER
60 MINUTES
ALL 6 TAB DISINTEGRATE
ANY TABLET NOT DISINTEGRATED
PASS
REPEAT
6 TABLETS 0.1 N HCl
60 MINUTES
ALL 6 TAB DISINTEGRATE
ANY TAB NOT DISINTEGRATE
PASS
REPEAT
12 TAB 0.1 N HCl
60 MINUTES
16 OR MORE TAB DISINTEGRATE
LESS THAN 16 TAB DISINTEGRATE
PASS
FAIL

14.  1. PLACE ONE TABLET IN EACH OF 6 TUBES
 2. IMMERSE BASKET FOR 5 MINUTES IN WATER
IF SOLUBLE COATING
TABLETS ,MEDIUM &
TIME
OBSERVATION RESULT
6 WITHOUT DISC
0.1 N HCl
120 MINUTES
NO TAB. SHOWS SIGN OF
DISINTEGRATION
STEP 2
6 TABS ADD DISC
PHOSPHATE BUFFER(6.8)
60 MINUTES
ALL 6 TAB DISINTEGRATE
ANY TABLET NOT DISINTEGRATE
PASS
REPEAT
12 TABLETS
PHOSPHATE BUFFER(6.8)
60 MIN
16 OR MORE TAB DISINTEGRATE
LASS THAN 16 TAB DISINTEGRATE
PASS
FAIL

15.  FOR MEASURING AMOUNT OF TIME REQUIRED
FOR A GIVEN PERCENTAGE OF THE DRUG
SUBSTANCE IN THE TABLET TO GO INTO
SOLUTION.

16. 1.A CYLINDRICAL COVERED VESSEL 1000 ml.
2. COVER LID HAS 4 HOLES
- 1 FOR SHAFT OF STIRRER
- 1 FOR THERMOMETER
- 2 FOR SAMPLING
3.AN ELECTRICAL MOTOR CAPABLE OF RATATING
BASKET, SPEED 25-150 RPM
4.STAINLESS STEEL BASKET OF WOVEN WIRE CLOTH
, APARTURE SIZE 425 MICRON
5.WATER BATH MAINTAINED AT 37± 2 ºc,
ARRANGEMENT FOR SMOOTH MOTION OF
WATER.

17.  PLACE 1000 Ml WATER FREE FROM DISSOLVED
AIR,PREVIOUSLY WARMED AT 37± 2 ºc.
 PLACE SPECIFIED NUMBER OF TABLETS.
 SET THE APPARATUS.
 START MOTOR , ADJUST SPEED AT 100 RPM OR
AS PER MONOGRAPH.
 WITHDRAW SAMPLE AFTER 45 MIN OR AFTER
TIME SPECIFIED IN MONOGRAPH.
 DETERMINE AMOUNT OF ACTIVE INGREDIENT
BY METHOD SPECIFIED IN MONOGRAPH.
 REPEAT THE TEST 4 TIMES

18. TABLETS OBSERVATION
5 AMOUNT OF ACTIVE
INGREDIENT IN
SOLUTION IS NOT LESS
THAN 70% FOR EACH
TABLET
ANY TAB FAILS
PASS
FAILS (NO RETESTING)
TWO OR MORE TABS
PLACED TOGETHER
AMOUNT OF ACTIVE
INGREDIENT IN
SOLUTION IS NOT LESS
THAN 70% FOR EACH
TABLET
ANY TAB FAILS
PASS
FAIL (NO RETESTING)

19.  PHARMACOPOEIA HAS NOT FIXED ANY LIMIT
FOR HARDNESS OF TABLETS
 FOLLOWING DEVICES ARE COMMONLY USED
BY MANUFACTURERS
 (1) MONSANTO HARDNESS TESTER
 (2) PFIZER HARDNESS TESTER

20.  SPRING-PRESSURE DEVICE TO TEST HARDNESS OF
A TABLET
 IT HAS A GRADUATED SCALE WHICH GIVES
READING IN Kg/Sq cm.
 TABLET TO BE TESTED IS PLACED BETWEEN
SPINDLE AND ANVIL
 DESIRED PRESSURE TO HOLD THE TABLET IN
POSITION IS APPLIED BY MOVING THE SCREW
KNOB IN CLOCKWISE DIRECTION
 SCALE IS MOVED SOTHAT THE INDICATOR IS
FIXED AT ZERO.
 PRESSURE IS THEN APPLIED TILL THE TABLET IS
NEEDED TO BREAK THE TABLET.

22.  IT IS BASED ON PRINCIPLE OF AN ORDINARY
PLIER.
 IT IS A PLIER FITTED WITH A PRESSURE DIAL.
 TABLET IS PLACED BETWEEN THE JAW OF THE
PLIER AND PRESSURE IS APPLIED BY PRESSING
THE HANDLES.

24.  FRIABILITY TEST IS PERFORMED TO EVALUATE
THE ABILITY OF A TABLET TO WITHSTAND
WEAR AND TEAR IN PACKING,HANDLING AND
TRANSPORTATION.
 THE APPARATUS USED TO PERFORM THIS
TEST IS KNOWN AS FRIABILATOR.
 IT CONSISTS OF A PLASTIC CHAMBER WHICH
IS DIVIDED INTO TWO PARTS AND IS
REVOLVED AT A SPEED OF25 RPM.

26.  WEIGH 20 TABLETS
 PLACE TABLETS IN CHAMBER
 CHAMBER IS ROTATED FOR 4 MINUTES OR
100 REVOLUTIONS.
 DURING EACH REVOLUTION TABLET FALLS
FRO A DISTANCE OF 6 INCH.
 TABLETS ARE REMOVED AFTER 100
REVOLUTIONS
 LOSS IN WEIGHT INDICATES FRIABILITY
 TABLET IS OF GOOD QUALITY IF WEIGHT LOSS
IS LESS THAN 0.8%.