This document discusses soft gelatin capsules and their quality control testing. It provides details on: 1) Soft gelatin capsules consist of a liquid or semisolid center surrounded by a gelatin shell that can contain the active ingredient. 2) Quality control tests for soft gelatin capsules include checking their shape, size, color, thickness, leakage, disintegration, and weight variation. 3) Content uniformity is tested by individually weighing capsules, removing the contents, weighing the shells, and calculating the net contents.

1. Prepared By-
Dinisha Sharma
17HPH044

2. It is the dept. in the Pharmaceutical Company
where the quality analyst attempts to
determine the concerntration of a specific
substance in the sample

3.  It is a solid capsule surrounding a liquid or
semisolid center.
 API can be incorporated in the outer shell,
inner fill or both
 Shells of the SGC are combination of gelatin,
water, opacifiers and plasticizers

4.  Soft gelatin capsules are subjected for
following tests during quality control:
1.Shape and size
2.Colour
3.Thickness of the capsule shell
4. Leaking test
5.Disintegration tests
6.Weight variation test
7.Percentage of medicament test

5. To check content uniformity of soft gelatin capsules we
need to follow the steps below:
Weight the capsules individually
Then cut & open the capsules
Remove the contents by washing with a suitable solvent
Allow the solvent to evaporate from the shells at room
temperature
Weight the individual shells
Calculate the net contents

6.  Disintegration test apparatus is used.
 One capsule is placed in each tube which are
suspended in the beakers to move up and
down for 30 minutes.
 The capsule pass the test if no drug or
fragments of shell remains on #10 mesh

7.  20 capsules are taken at random and
weighed.
 Average weight is calculated
 Each capsule is weighed individually and their
weight noted.
 The capsule passes the test if the weight of
individual capsule falls within 90-110% of the
average weight

8.  The leakage of soft gelatin capsules are determined
by following factors-
1.Bloom or gel strength-It is a cohesive strength of
cross-linking that occurs between gelatin molecules
and is proportional to the mol. wt.
2. Viscosity of gelatin-It is a measure of chain length &
manufacturing characterstic of gelatin film
3.Iron content-It is present in raw gelatin as well as
water used in manufacture. Excess qty. of iron can
effect the formulation and react with organic
compounds

9.  The test is perfomed to find out the integrity
of capsule shell. The standard capsule shells
are kept at room temperature 40°C and 80%
RH becomes more soft, sticky and swollen

10.  Base adsorption is expressed as the number of grams
of liquid base required to produce a capsulatable
mixture when mixed with one gram of solids.
 The base adsorption of a solid is influenced by such
factors
The solids particle size and shape,
Its physical state
Its density
Its moisture content, and
Its lipophilic or hydrophilic nature
 The base adsorption is obtainedby-
weight of the base/weight of the solid= Base Adsorption

11. Weight the definite amount(40g is convenient) of the
solid substance into a 150ml tared beaker
In a separate 150ml tared beaker place 100g of the solid
base
Add small amount of liquid base into the solid and stir it
with spatula until consistent soft ointment is produced
Continue to add liquid until the mixture flows steadily
from the spatula blade when held at a 45 degree angle
above the mixture
Calculate the base adsorption using the above given
formula

12.  The base adsoorption is used to determine the “minim per
gram” factor (M/g) of the solid(s).
 The minim per gram factor is the volume in minims that is
occupied by one gram of the solid plus the weight of the
liquid base(BA) required to make capsulatable mixture.
 The minim per gram factor is calculated by dividing the
weight of the base plus the gram of solid base (BA+S) by the
weight of the mixture (W) per cubic centimeter or 16.23
minims (V).
(BA+S) x V/W = M/g
Thus lower the base absorption of the solids and higher the
density of the mixture, the smaller the capsule will be.