QUALITY CONTROL OF SOLID

DOSAGE FORMS
BY

SANA

GHAYAS
◉ (COURSE # 607) (Pharmaceutical Quality
Managements-II) (Theory) Cr. Hr. 03.

◉ QUALITY CONTROL OF SOLID DOSAGE FORMS:

a). Physical tests: Hardness, Thickness and

Diameter, Friability, Disintegration. Weight
Variation.

b). Chemical Test: Content uniformity, Assay of

active ingredients and dissolution tests of
Powders, Granules, Tablets and Capsules.
LEARNING OBJECTIVES:
At the end of this lecture, students will be able
to:
◉ Describe physical and chemical tests of solid
dosage forms.
◉ Know how and why they are carried out.
◉ The following standards or quality
control tests should be carried out on
compressed tablets.
◉ General appearance
◉ Content Uniformity
◉ Mechanical strength of
tablets
◉ Disintegration
◉ Dissolution
1. General
appearance Size and
shape Organoleptic
properties
(1) UNIFORMITY OF DIAMETER:
- For uncoated tablets.
- Investigated by measuring the diameter of
20 randomly taken tablets and calculate
the average diameter.
◉ Limit:
a- If the stated diameter is less than 12.5 mm,
a deviation of 5% of the average diameter
is allowed.
b- If the stated diameter exceeds 12.5 mm, a
deviation of 3% of the average diameter is
allowed.
(2) Uniformity Of Thickness:
- Investigated by measuring the thickness of 20
randomly taken tablets and calculate the
average thickness.
◉ Limit: A deviation of 5% of the average thickness is
allowed.
 WEIGHT VARIATION TEST
FOR TABLET:
◉ Applicable when the tablet contains
50 mg or more of the drug substance.

AVERAGE PERCENT
WEIGHT DIFFERENCE

130 mg or less 10%

More than 130 mg through 7.5%

324 mg
More than 324 mg 5%
◉ WEIGHT VARIATION TEST FOR HARD GELATIN
CAPSULES AND FOR SOFT GELATIN CAPSULES:
◉ HARD GELATIN CAPSULE:
◉ Method A
◉ Weigh a capsule open it without loss of shell material
◉ Remove the contents and weigh all parts of shell
◉ The difference between the weights represent the
weight of contents
◉ Repeat the operation with a further of 19 capsules
and calculate the average weight of contents of 20
capsules.
◉ Method B
◉ Weigh 20 capsules individually, and determine the
average weight.
◉ The individual weights should be within the limits of
90%and 110%of the average weight
WEIGHT VARIATION TEST FOR HARD GELATIN
CAPSULES AND FOR SOFT GELATIN CAPSULES:
◉ HARD GELATIN CAPSULE:
1. Method A
Limit:
◉ Not more than two of the individual weights
deviate from the average weight by more
than the percentage deviation shown in the
table, and none deviates by more than twice
that percentage.
OR
2. Method B
◉ The individual weights should be within the
limits of 90%and 110%of the average
weight.
SOFT GELATIN
CAPSULES:

The weight of the

contents of each
capsule does not
differ from the
average weight by
more than 7.5%,
except that for 1
capsule the weight
of the contents may
differ by not more
than 15 %
◉ Drug content uniformity of tablets
◉ According to United StatesPharmacopoeia:
◉ Stage1: Take 10 units randomly and perform
the assay.
◉ It passes the test if the relative standard
deviation (RSD) is less than 6% and no value
is outside 85–115%.
◉ Fails the test if one or more values are outside
75–125%.
◉ ●Stage2: Take 20 more units and perform the
assay procedure.
◉ Passes the test if RSD of all the 30 tablets is
less than 7.8%, not more than one value is
outside 85–115%, and no value is
Procedure according to British pharmacopoeia :
◉ TestA
◉ This test is applicable for tablets, powders for
parenteral use and suspensions for injection.
◉ Select 10 units at random. Passes the test if each
individual unit is between 85% and 115% of the
average content.
◉ Fails the test if more than one individual
unit is outside these limits or if even one is outside
the limits of 75% to 125% of the average content.
◉ But if one unit is outside the limits of 85%
to115% and within 75%to125%, then take
another 10 units at random and perform the
assay.
◉ The lot passes the test if not more than one unit of
the thirty units is outside 85% to 115%, and not
even one unit is outside the limits of 75% to 125%
◉ Test B
◉ This method is used for capsules, powders other than for
parenteral use, granules,suppositories and pessaries.
◉ The batch passes the test if not more than one individual
unit (out of 10 units selected at random from a lot) is
outside the limits of 85% to 115% and none is outside
the limits of 75%
to 125% of the labelled content.
◉ The batch fails the test if more than three units are
outside the limits of 85% to 115% or if one or more units
are outside the limits of 75% to 125% of the labelled
content.
◉ If two or three units are outside the limits of 85% to
115%, but within the limits of 75% to 125%, then
select another 20 units at random.
◉ The batch complies the test when not more than three
units out of these thirty units are outside the limits of 85%
to 115% and not even one unit is outside the limits of
◉ Test C
This test is appicable only for transdermal
patches.
◉ The preparation passes test only if the
average content of the 10 units is between
90% and 110%,
and if the content of each unit is between
75% and 125% of the average content.
3. Mechanical strength of tablets
◉ Provides a measure of the bonding
potential of the material
◉ The mechanical properties of
pharmaceutical tablets are
quantifiable by:
◉ Friability
◉ Hardness or Crushing strength
FRIABILITY TEST FOR TABLETS.
◉ Evaluate the ability of the tablet to
withstand abrasion in packaging, handling
and shipping.
◉ The commonly used friabilator in
laboratories is the roche friabilator.
◉ The tablets are subjected to combined
effects of abrasion and shock.
◉ The instrument is operated for 100
revolutions after which the tablets are
dusted and reweighed.
◉ Conventional compressed tablets that lose
less than 0.5% to 1% of weight are
Hardness or Crushing strength
of Tablets
◉ Importance of hardness test.
◉ Monsanto or stokes hardness tester.
◉ Determination of
hardness???????????
◉ Measured in kilograms
◉ Limits??????
 Five types of testers are used:
◉ Monsanto hardness tester or stokes
hardness teste
◉ Strong cobb tester

◉ Pfizer tester

◉ Erweka tester

◉ Schleuniger or heberlein tester

LEARNING OBJECTIVES:
At the end of this lecture, students will be able
to:
◉ Define disintegration.
◉ Describe disintegration apparatus.
◉ Describe disintegration test methods
for different dosage form and its
specifications.
◉ Compare the test methods in different
Pharmacopoeia.
DISINTEGRATION.
◉ Breakdown of the tablet into smaller particles
or granules, a process known -as
disintegration.
◉ The USP disintegration apparatus.
◉ Specifications for test.
◉ A standard motor-driven device is used to
move the basket assembly
◉ Perforated plastic discs may also be used in
the test.
◉ To be in compliance with the USP standards,
the tablets must disintegrate all particles.
◉ Uncoated USP tablets have disintegration time
standards as low as 5 min, maximum
◉ DISSOLUTION.

◉ Dissolution is the process by which a solid solute

enters a solution.
◉ In the pharmaceutical industry, it may be defined
as the amount of drug substance that goes into
solution per unit time under standardized
conditions of liquid/solid interface, temperature
and solvent composition.
◉ Dissolution is considered one of the most
important quality control tests performed on
pharmaceutical dosage forms and is now
developing into a tool for predicting
bioavailability, and in some cases, replacing
clinical studies to determine bioequivalence.
◉ Most important quality control tests,
determine bioequivalence, in vitro-in
vivocorrelation, IVIVC .
◉ Use of in vivo studies is restricted, however,
for several reasons???????
◉ Dissolution test :
◉ Different types of dissolution apparatus :
1. Basket type.
2. Paddle type.
3. Reciprocating paddle.
4. Flow through cell.
5. Paddle over disc.
6. Cylinder with membrane.
7. Reciprocating cylinder .

8. Conditions maintained : Temperature :

37±0.5˚ C Speed : 25-150 rpm
Two apparatuses be used
for determining
dissolution rates:
◉ Apparatus 1.
◉ Single tablet is placed in
a small wire mesh
basket connected to a
variable speed motor.
◉ immersed in the
dissolution medium.
◉ Maintained at 37°c ±
0.5°C.
◉ Apparatus 2.
◉ The same equipment
as in apparatus 1 is
used, except that the
basket is replaced by a
paddle
◉ Description of a
dissolution test in USP/
NF monograph
specifies:
▪ The dissolution test
medium and volume
▪ Apparatus is to be used
▪ The speed (rpm) at
which the test is to be
performed
▪ The time limit of the
◉ Procedure : Total tablets taken = 24

◉ S1 : 6 tablets taken Acceptable: If all of the

tablets are not less than (NLT) the
monograph tolerance limit(Q)= ± 5%.

◉ If S1 fails S2 : Another 6 tables are taken

Acceptable : If average of 12 tablets is ≥ Q &
no tablet is less than Q-15%

◉ If S2 fails S3 : 12 tablets taken Acceptable :

No tablet less than Q & not more than 2
tablets = Q-15%.
REFERENCES:

◉ Lachman L, Lieberman H, Kanig J. The theory

and practice of industrial pharmacy.
Varghese publication house, 3rd edition, page-
299.
◉ M. E. Aulton, Pharmaceutics: Science of
dosage forms design, ELBS / Churchill
Livingston, London 1998.
◉ Ansel, Pharmaceutical Dosage form in Drug
Delivery System, Lee & Febiger, London, 1990.
◉ US Pharmacopoeia 29 NF