Analysis of capsules

Analysis of capsules

1. QC test
Hard Gelatin Capsule
Soft Gelatin Capsule
Analysis of CAPSULES
By:RajeshL. Dumpala
(B.Pharm, M. Pharm.) PhD. ( Pursuing)
Research Scientist,
Alembic Research Centre. Vadodara
E.Mail:[email protected]

2. [FOR HARD GELATIN CAPSULE]
Raw Material Testing
Gelatin
Bloom strength
Viscosity
Ph
Moisture
Clarity &Color of solution
Water insoluble substances
Ash
So2
Arsenic
Heavy metals
Microbial limits

3. Item A grade B grade C grade
Bloom(6.67%Solution)g≥ 200 160 140
Visco.（6.67%Solution60℃）
CP≥
4.2 3.7 3.2
PH（1%Solution） 5.5 –7.0
Moisture %≤ 14
Clarity and Color of Solution
(mm)
150 100 50
Water Insoluble Substances %≤ 0.2
Ash %≤ 1.0 2.0 2.0
SO
2 (ppm) 100
Arsenic (ppm) 0.8
Heavy Metal (ppm) 50
Microbial Limits per g ≤ 1000
Salmonella Negative
E.Coli Negative

4. Bloom strength determination:
Thegelstrengthofgelatinisameasureoftherigidityofagel
formedfrom6.67%solution.Bloomisameasureofforce
(weight)requiredtodepressaprescribeareaofthesurfaceofthe
sampleadistanceof4mm.

5. FINAL PRODUCT TEST
PHRMACOPIEAL STANDARDS
1. Weight Variation
Accurately weigh 10 capsules.
By suitable means the contents of each
capsule should be removed.
The weights of emptied shells should be
recorded individually
The difference of both the weights will
yield the net weight of the contents.
Then calculate acceptance value.

6. 2.Content of active ingredients
Determinetheamountofactiveingredientbythe
methoddescribedinassayofrespectivemonograph.
Theresultlieswithintherangeforthecontentof
activeingredient(s)statedinthemonograph.
Weight of active ingredients
in each capsule
Substractfrom the lower
limit forsamples of
Add to the upper lomitfor
samples of
5 10 15 5 10 15
<0.12 1.5 0.7 0.2 1.8 0.6 0.3
>0.12–0.3 < 1.2 0.5 0.2 1.5 0.6 0.3
> 0.3 g 0.8 0.2 0.1 1.0 0.4 0.2
TABLE

7. 3.Uniformityof weight
Open the
capsule
without losing
any part of the
shell and
remove the
contents as
completely as
possible.
To remove the
contents of a
soft capsule
the shell may
be washed
with ether or
other suitable
solvent and the
shell allowed to
stand until the
odourof the
solvent is no
longer
detectable.
Weigh the
shell.
The weight of
the contents is
the difference
between the
weightings.
Repeat the
procedure with
a further 19
capsules.
Determine the
average
weight.

8. 4.Content uniformity
Hard capsules containing 25 mg or more of the drug contents
should meet content uniformity requirements.
Assay 10 capsules individually and calculate the acceptance value.
The requirement is met if the acceptance value of 10 capsules is
less than or equal to 15%.
CALCULATION OF ACCEPTANCE VALUE:
(Reference value-mean of individual contents ) + acceptability
constant * sample standard deviation

9. 5.Disintegration
The disintegration of capsules is different from those of
tablets because the determination of end point is difficult
owing to the adhesive nature of shell.
The shell pieces after disintegration may agglomerate
forming large mass of gelatin taking more time to dissolve
and may adhere to the mesh thus, blocking the holes.
•WaterMedium
•30 minOperation Time

10. Place each of
the capsules in
the dissolution
apparatus,
excluding air
bubbles from
the surface of
the capsule.
Operate
immediately
at specified
rate within
specified
dissolution
medium at 37
+ 0.5C.
Aliquots
should be
withdrawn at
specified time
points
mentioned in
individual
monograph.
The
requirements
are met if the
quantity of
active
ingredients
dissolved
conforms the
following
standareds
6. Dissolution

11. At stage 1 (S1): When
6 capsules are tested,
amount of each of the
dissolved content
should not be less than
+/-5% of the
mentioned in
monograph.
At stage 2 (S2): when 6
capsules are tested, the
average of 12 (both
from step 1and 2)
should be equal to or
greater than 15% and
no capsule should be
than 15%.
At stage 3 (S3): when 12
capsules are tested, the
average of 24 capsules (all
1,2 and 3 steps) should be
equal to or greater than the
amount mentioned in the
monograph, not more than
two units are less than 15%
and no unit s less than 25%.
Standards for the capsules

12. Non PharmacopiealTests
or
Industrial Standards
•Color
•Dimension
•Shape
•Odour
•Solubility
•Brittleness
•Printing
Appearance
of capsules

13. [FOR SOFT GELATINE CAPSULES]
Raw Material Testing
•Bloom strength
•Viscosity
•Moisture
•pH
•Practical size
•Clarity
•Microbial standards
•Presence of SO
2
•Presence of H
2O
2
Gelatin

14. FINAL PRODUCT TEST
PHRMACOPIEAL STANDARD
Pre weigh 10 capsules.
Cut the capsules by suitable means (either scissors or any open
blade).`
Remove the contents by washing with a suitable solvent and let the
solvent evaporate by placing them at room temperature for
about 30 mins.
Weigh the individual shells.
Calculate the acceptance value.
1.Weight variation

15. Content uniformity
Disintegration
Dissolution
Moisture content
Microbial test
Rupture test

16. NON PHARMACOPIEAL TESTS
or
INDUSTRIAL STANDRDS
Dimension
CapsuleShape
Solubility
Odour
pH
Leakage
Pellicleformation:
Culturesgrowingonthesurfaceofliquidmediaoftenforma
moreorlesscontinuousfilmcalledapellicle.Thisfilm
consistsofmicrobialcellsandtheirextracellularproducts..