9. 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
B.P
10. 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
12. 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
15. 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
16. 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
19. 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. 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
25.
26. 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
Uniformity Of Mass (BP)
27. 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
29. 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
30. 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)
31. 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
Membrane filtration method
32. Active
ingredients
-Assay of active ingredients should
be performed according to
monograph -Percentage contents
should be within the official limits
33. 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.
