Pharmacopoeial Standards

for tablet

Indian Pharmacopoeia
Types of Tablet

Uncoated
Film Coated
Enteric Coated
Dispersible Tablet
Modified Release Tablet
Soluble Tablet
Effervescent Tablet
For use in mouth
(Chewable, Lozenges,
Sublingual)
Orodispersible

Standards for Tablets

Content of Active Ingredient

Uniformity of weight
Uniformity of Content
Disintegration
Friability Test
Uniformity of dispersion
Dissolution

Content of Active Ingredient

1) Assay of Active
2) 20 tabs: - take avg. weight of tablet
and follow procedure as per assay.

Uniformity of Content or
Content Uniformity
IP: - Active less than 10mg or 10%,
BP:- Active less than 2 mg or 2%,
USP:- Active less than 25mg or 25%.
10 tabs limit NMT 1 tab deviate 85 115% & none
outside 75 125% of the Avg value/IP/BP/USP (Relative
Standard Deviation less than or equal to 6%),
If 2 or 3 individual values are outside the limits 85
115% of the Avg value, & none outside 75 125%
repeat for 20 tabs.
Complies when 30 tabs NMT 3 of the individual values
are outside the limit 85 115% of the Avg value, and
none outside 75 125%.

Weight Variation Limits

IP/BP

Limit

USP

80 mg or less

10%

130mg or less

More than 80mg or

Less than 250mg

7.5%

130mg to 324mg

250mg or more

5%

More than 324mg

Weigh individually 20 units selected at random or, for singledose

preparations in individual containers, the contents of 20 units, and
calculate the average weight. Not more than two of the individual
weights deviate from the average weight by more than the
percentage shown in the table and none deviates by more than
twice that percentage.

Disintegration
Uncoated
Tablet
Coated
Tablet

NMT 15 min, in water with Disc

370C 20C
NMT 30 min, In water with Disc
for Film Coated Tab, and NMT 60
min Other than Film coated
tablet
Enteric
Intact for 1 hr in 0.1 N HCl &
Coated Tab disintegrate within 2 hr in Mixed
6.8 Phosphate buffer. According
to USP 1 hr in Simulated gastric
fluid, then in Simulated Intestinal
Fluid.
Dispersible/
Within
min in water
250C
DT Apparatus:Mesh3Apperture:2mmat(#10),
0
Soluble
10cycles/min,
C (IP) & 1550
25
Cmm
(BP)
Cycles:- 28 32
60
distance
Orodispersi
1 min
from bottom & Within
top, Temp
of water 370C 20C. If 1
ble
or 2 tablets or capsules fail to disintegrate, repeat

Friability Test
This test is additional to check crushing strength of
tablet by this test one can check Capping &/or
Lamination. USP limit is 0.5 to 1%. Rotation: - 25 rpm or
100 rotations in 4 min.
For tablets weight equal to or less than 650 mg, take
tablets corresponding to 6.5 g. For tablets with a unit
mass of more than 650 mg, take a sample of 10 tablets.
The tablets should be carefully dedusted prior to
testing. Accurately weigh the tablet , and place the
tablets in the drum. Rotate the drum 100 times, and
remove the tablets. Remove any loose dust from the
tablets as before, and accurately weigh.

Uniformity of dispersion
Place 2 tablets in 100 ml of water
and stir gently until completely
dispersed. A smooth dispersion is
obtained which passes through a
sieve screen with a nominal mesh
aperture of 710 mm (sieve number
22).

Dissolution
Conventional-release dosage forms
LEV
EL

NUMBE
R
TESTED

ACCEPTANCE CRITERIA

S1

Each unit is not less than D* + 5 per cent**.

S2

Average of 12 units (S1 +S2) is equal to or greater than

D, and no unit is less than D 15 per cent**.

S3

12

Average of 24 units (S1+S2+S3)is equal to or greater

than D, not, More than 2 units are less than D 15 per
cent** and no unit is less than D 25 per cent**.

*D is the amount of dissolved active ingredient specified in the

individual monograph, expressed as a percentage of the labelled
content.
**Percentages
of specified,
the labelled
Unless
otherwise
thecontent.
requirements are met if the
quantities of active substance dissolved from the dosage units
conform to above Table. If the results do not conform to the
requirements at stage S1 given in the table, continue testing
with additional dosage units through stages S2 and S3 unless the
results conform at stage S2.

Prolonged-release dosage forms

Unless otherwise specified, the requirements are met if the quantities
of active substance dissolved from the dosage units conform to Table
2. If the results do not conform to the requirements at stage L1 given
in the table, continue testing with additional dosage units through
stages L2 and L3 unless the results conform at stage L2. The limits
embrace each value of D, the amount dissolved at each specified
dosing interval. Where more than one range is specified, the
acceptance criteria apply to each range.

Level

Number
tested

Acceptance criteria

L1

L2

L3

12

No individual value lies outside each of

the stated ranges and no individual
value is less than the stated amount at
the final test time.
The average value of the 12 units (L1 +
L2) lies within each of the stated ranges
and is not less than the stated amount at
the final test time; none is more than 10
per cent of labelled content outside each
of the stated ranges; and none is more
than 10 per cent of labelled amount
below the stated amount at the final test
time.
The average value of the 24 units (L1 +
L2 + L3) lies within each of the stated
ranges, and is not less than the stated

USP

Modified-release dosage forms

Method A
Acid stage- Place 750 ml of 0.1M HCL in the vessel, and
assemble the apparatus. Warm the dissolution medium to
36.5 to 37.5. Place one dosage unit in the apparatus,
cover the vessel and operate the apparatus at the specified
rate. After 2 hours of operation in the acid medium,
withdraw an aliquot of the liquid and proceed immediately
as directed under Buffer stage. Perform the analysis of the
aliquot using a suitable assay method.
Buffer stage- Complete the operations of adding the
buffer and adjusting the pH within 5 minutes. With the
apparatus operating at the rate specified, add to the
medium in the vessel 250 ml of a 0.2 M solution of
trisodium phosphate dodecahydrate that has been warmed
to 36.5 to 37.5. Adjust, if necessary, with 2M HCL or 2M
NAOH to a pH of 6.8 0.05. 2M HCL or 2M NAOH to a pH of
6.8 0.05.

Method B
Acid stage- Place 1000 ml of 0.1M HCL in the vessel and assemble the
apparatus. Set temp. 36.5 to 37.5. Place one dosage unit in the
apparatus. After 2 hours of operation in the acid medium, withdraw an
aliquot of the liquid and proceed immediately as directed under Buffer
stage. Perform the analysis of the aliquot using a suitable assay method.
Buffer stage- Use buffer that has previously been warmed to 36.5 to
37.5. 1000 ml of pH 6.8 phosphate buffer, prepared by mixing 3 volumes
of 0.1M HCL with 1 volume of 0.2 M solution of trisodium phosphate
dodecahydrate and adjusting, if necessary, with 2M HCL or 2M NAOH to a
pH of 6.8 0.05. This may also be done by removing from the apparatus
the vessel containing the acid and replacing it with another vessel
containing the buffer and transferring the dosage unit to the vessel
containing the buffer. Continue to operate the apparatus for 45 minutes,
or for the specified time. At the end of this period, withdraw an aliquot of
the liquid and perform the analysis using a suitable assay method.

Acid stage
Lev
el

Numb Acceptance criteria

er
teste
d

A1

No individual value exceeds 10 per cent dissolved.

A2

The average value of the 12 units (A1 + A2) is not more

than 10 per cent dissolved, and no individual unit is
greater than 25 per cent dissolved.

A3

12

The average value of the 24 units (A1 + A2 + A3) is not

more than 10 per cent dissolved, and no individual unit
is greater than 25 per cent dissolved.

Acid stage- Unless otherwise specified, the

requirements of this part of the test are met
if the quantities, based on the percentage of
the labelled content of active substance
dissolved from the units tested conform to

BUFFER STAGE

LEV
EL

Numb
er
tested

Acceptance criteria

B1

No unit is less than D + 5 per cent*

B2

The average value of the 12 units (B1 + B2) is equal

to or greater than D,and no unit is less than D 15
per cent*.

B3

12

The average value of 24 units (B1 + B2 + B3) is

equal to or greater than D, not more than 2 units are
less than D 15 per cent*, and no unit is less than D
25labelled
per cent*.
percentages of the
content.

Buffer stage. Unless otherwise specified, the

requirements of this part of the test are met if the
quantities, based on the percentage of the labelled
content of active substance dissolved from the
units tested conform to Table 4. Continue the
testing through the 3 levels unless the results of
both acid and buffer stages conform at an earlier