This document outlines quality control and assurance tests for different dosage forms including tablets, capsules, and creams. For tablets, it discusses tests like disintegration, dissolution, hardness, thickness, and weight variation according to British and United States pharmacopoeia. For capsules, it discusses weight variation, content uniformity, disintegration, and dissolution tests. For creams, it discusses tests like physical appearance, particle size, weight variation, solubility, viscosity, microbial contamination, and assay of active ingredients.

2. Quality control and
Quality assurance
tests for different
dosage forms

3. TABLETS

4. OFFICIAL TESTS
BRITISH PHARMACOPOEIA
Gastro resistant tablet:
 Disintegration test
Modified release tablet:
 Uniformity of weight.
Dispersible tablet:
 Disintegration test
 Uniformity of dispersion
 Uniformity of weight
Uncoated and Coated Tablets:
 Disintegration test
 Uniformity of weight
UNITED STATE PHARMACOPOEIA
 Weight variation
 Disintegration
 Dissolution
 Drug content

5. Tests for tablets
Dissolution tests
Disintegration test
Friability testing
Tablet hardness
Diameter and thickness
Weight variation tests

6. Dissolution test

8. LIMITS

9. DISINTEGRATION TESTS
Purpose:
To assure product uniformity
Attempts are made to simulate in-
vivo conditions
Actually test does not correlate with
physiological conditions
often done as in process control

11. Limits:
For Uncoated tablets

13. DISINTEGRATION
TESTING (BP)
TYPES OF TABLETS RANGES
Uncoated 15 min or as per individual monograph
Film coated 30 min or as per individual monograph
Sugar coated 60 min or as per individual monograph
Dispersible tablets 03 min or as per individual monograph
Effervescent tablets 05 min or as per individual monograph
Enteric coated tablets 60 min in buffer :disintegrate
Soluble tablets 03 minutes

14. DISINTEGRATION
TESTING(USP)
TYPES OF TABLETS RANGES
Uncoated tablets As per individual monograph
Plain coated tablets 30 minutes
Enteric coated tablets 01 hour
Buccal tablets 04 hours
Sublingual tablets 02 minutes

17. Procedure:
1. Weigh 20 tab altogether = W1
2. Put these tablets in the friabilator and adjust the instrument
at 100 rpm (i.e. = 25 rpm for 4 min)
3. Weigh the 20 tablets (only the intact ones) = W2
4. Friability (% loss) =
It must be less than or equal to1% but if more we do not
reject the tablets as this test is non-official.
Perform this test using 20 tablets that were used first in the
weight variation test

19. THICKNESS TEST
Checking of thickness and diameter is usually an in-
process control during production
Dimensional specifications of tablets are important
because of many reasons e.g.
1. Packaging requirements
2. Patient compliance
3. Thickness is often related to tablet hardness
Directly affect the assay
Instruments used
• Micrometer
• Vernier calliper
• Now a days digital micrometers are available

20. Specifications for thickness
Limits of thickness depends on tablet weight
• Thickness of majority of tablets varies from 2 mm to 4 mm
depending on diameter of tablet
• A deviation of ± 5% from stated diameter is allowed except
that for exceeding 12.5 mm
For 12.5 mm or above deviation is ± 3%
when the compression of a tablet is increased, its hardness
decreases, but the thickness increases. When the percentage
of active ingredient is increased, the hardness decreases and
the thickness is unaffected. The diameter of the pill remains
relatively unaffected

21. WEIGHT VARIATION
(UNIFORMITY OF WEIGHT)
• Weigh individually 20 whole tablets.
• Calculate average weight.
• Weight of not more than two tablet differ
from the average weight by more than
percentage given in table.
• No tablet differ by more than double the
% age given

22. USP Specifications
BP / IP
Specifications

23. WEIGHT VARIATION
TOLERANCES FOR
UNCOATED TABLETS IN USP
XVII
AVERAGE WEIGHT OF TABLETS
(mg)
PERCENTAGE DIFFERENCE
130 Or less ± 10.0
From 130 through 324 ± 7.5
More than 324 ±5.0

24. CAPSUL
ES

25. QUALITYCONTROLTEST:
• Weight variation
• Content uniformity
• Disintegration
• Dissolution
• Chemical or biological assay

27. WEIGHT VARIATION
There are two methods for testing uniformity of weight of capsules
Method A
Method B
Method A
• Method A is for capsules with dry contents
• Weigh a capsule, open it without loss of shell material,
remove the contents, and weigh all parts of shell
• The difference between the weights represents the weight of
contents of capsule
• Repeat the operation with further 19 capsules (total 20)
• Capsules pass the test if not more than 2 capsules deviate
from the mean weight by more than percentage given in table
(10 % for 0.120 g or less and 7.5 % for more than 0.120 g)
• For one or two capsules (which are outside above given
range) the weight of content should not more than percentage
given in table below (i.e. 20 % for 0.120 g or less and 15 % for

28. Specification for weight variation of capsule

29. DISINTEGRATION
TIME
BP USP
Hard capsule < 30 min < 30 min
Soft capsule < 60 min < 60 min
Enteric Disintegrate in buffer in 60 min,
Disintegrate in HCL in 2 hours.
NS
Gastro -resistant NS NS

30. UNIFORMITY OF
MASS (BP)
PHARMACEUTI-CAL
FORMS
AVERAGE MASS NO OF CAPSULES PERCENTAGE
DEVIATION
Capsules
(uncoated, single dose
and powders)
Less than 300 mg Min 18
Max 2
10
300 mg or more Min 18
Max 2
7.5

31. ASSAY OF ACTIVE
INGREDIENT (USP)
WEIGHT OF API IN EACH
CAPSULE
SUBTRACT FROM THE LOWER
LIMIT FOR SAMPLE OF
ADD TO THE UPPER LIMIT FOR
SAMPLE OF
15 10 5 15 10 5
0.12 g or less 0.2 0.7 1.5 0.3 0.8 1.8
More than 0.12 g or less than 0.3
g
0.2 0.5 1.2 0.3 0.6 1.5
0.3 g or more 0.1 0.2 0.8 0.2 0.4 1.0

32. CREAMS

33. PHYSICAL APPEARANCE
The main characteristics need to be checked
are -Cracking of creams (separation of oil and
water) -Development of granular and lumpy
appearance -Marked change in viscosity -
Crystal growth -Microbial contamination
Particle size determination
-Dilute a suitable qty of preparation with equal
volume of glycerol or liquid paraffin, as
specified -Mount on a glass slide and
examine under light microscope -Count the
number of particles with diameter above or
below than that specified in monograph -
Compare the percentage with official limits

34. Weight variation test
-Applies to those products in which labeled net weight is not more
than 150g -Select 10 filled containers, remove the label, clean
and weigh individually -Remove the contents by cutting the
containers and wash with suitable solvent -Dry and again weigh
each empty container together with its corresponding part, take
difference as weight of contents. -The average net weight of
contents of 10 containers should not be less than the labeled
amount -The net weight of contents of any single container
should not be less than 90% of the labeled amount (for ≤ 60g) -
And not less than 95% of the labeled amount (60-150g) -If this
requirement is not met repeat this procedures taking additional
20 containers -The average net weight of contents of 30
containers should not be less than labeled amount -Contents of
not more than 1 of the 30 units should be less than 90% of the
stated amount (for ≤ 60g) -And not less than 95% of the labeled
amount (60-150g)

35. Solubility test -
-The preparation should be soluble in 9 parts of water
and 1.7 parts of hot water -The preparation should be
miscible with alcohol, ether and chloroform
Viscosity determination
Viscosity is determined using a method specified in
official monograph
Microbial contamination
-Microorganisms can grow, if no preservative is added,
or even if added, its efficiency is reduced due to
interaction with other ingredients -Microorganisms may
get into the preparation during handling and storage -
Therefore, aseptic techniques of handling are needed -
Antimicrobial assay should be performed according to
official monograph, usually Direct inoculation method

36. Active ingredients
-Assay of active ingredients should
be performed according to
monograph -Percentage contents
should be within the official limits

37. REFERENCES:
•Remington’s Pharmaceutical Sciences, Mack
Publishing Company , USA, 2001.
•5 Pharmacopoeias B.P, U.S.P, U.S.P/N.F, P.P.
•USP convention inc . The USP 19th rev .,Easton ,
PA., Mack Publishing Company ,1975
•Her Majesty's Stationary Office , BP
1988,Bristol,J.W.,arrowsmith Ltd.
•Pharmaceutical quality assurance in class industry
and market.

38. THANK YOU