Quality control test for capsule and finish product of capsule are
■ weight variation test
■ Dissolution test
■ Disintegration test
■ moisture permeation test
■ contents uniformity test
■ blooms gelatin strength .
1. IN PROCESS OF QUALITY
CONTROL TEST FOR CAPSULE
Rina suresh patil
T .Y.B pharm., Roll No. Dsp-06
Principle: Dr . Amol. D. Landge sir
Guided by : prof. Anis . A. Shaikh sir
2. • Define capsule .
• Type of capsule .
• What is the In process of Quality
control and its scope.
• What are In process Quality control
test of capsule.
Learning Outcomes
3. Capsule is the most versatile of all dosage
forms. Capsules are solid dosage forms in which
one or more medicinal and inert ingredients are
enclosed in a small shell or container usually made
of gelatin.
Capsule
5. Reflection Spot
• What is In process of Quality
control ?
• Why we need IPQC?
• and scope?
6. What is IPQC ?
IPQC is concerned with providing accurate,
specific and definite description of procedures to
be employed from the receipt of raw materials to
the release of finished dosage forms.
• IPQC procedures are generally quick, simple and
rapid tests or inspection that carried out at on
going manufacturing.
• In process quality control, IPQC tests are
performed within the production area.
7. • To defect the error
• To minimize the human error
• To provides accurate, specific and definite
description of the procedure to be
employed.
• To enforce the flow of manufacturing and
packing operations according to established
routes and practice.
Why we need IPQC ?
8. In process quality control are particularly
important where a process may be very
with Time such as tablet weight, fill
volume, etc.
Scope
9. IPQC tests for capsule .
• Viscosity
• Iron content
• Size and shape
• Content of active Ingredients
• Weight variation test
• Content uniformity
• Moisture permeation test
• Bloom strength of gelatin
10. It is a measure of the chain length and
manufacturing characteristics of gelatin film.the
required viscosity of gelatin lies in between 25 -45
mp.
Iron Content :
It is present in raw gelatin as well as water used
in manufacturing. Excess qty. Of iron can effect FD &C
&react with organic compounds. Hence,Iron is used in
the conc. Of not more than 15ppm.
Viscosity Gelatin Test
11. Size and shape of capsule
Hard capsule are made in a range of sizes ,
the standard industrial ones in use today for
human medicine range from size 000 (the largest,
1.40ml) to 5( the smallest,0.13ml) are
commercially available.
Soft gel capsules are available in variety of
shapes such as spherical ( 0.05-5ml), ovoid (0.05-
7ml), cylindrical (0.15-25ml),tube(0.5-0 ml),pear
(0.3- 5ml) etc.
12. This test a sample of the contents is assayed
as described in individual monographs and
calculates. the amount of active ingredient in each
Capsule .
According to IP the range for the content of
active ingredient stated in the monograph is based
on the requirement that 20 capsules or such other
number may be indicated in the monograph are
used in the assay.
Content of Active Ingredients
13. Weight variation test
Weight 20 capsule individually and determine the average weight.
Individual weight should be within the limit of 90% and 110% of average weight.
If not all of the capsule fall within the limit s,
Weight the 20 capsules individually
Remove the contents of each capsule with the aid of a small brush
For Hard Capsule:
Weight the emptied shell individually
14. Weight variation test
For soft capsule :
Weight the capsule individually then cut and open the capsules
Remove the contents by washing with the suitable solvent
Allow the solvent to evaporate from the shells at room temperature.
Weight the individual shells
Calculate the contents
15. Content Uniformity
To execute this test, total 10 capsule are subjected
to assay.
In all 9 to 10 capsules should be in the range of
+_ 15% (85-115%)and 10 capsules in the range of
75- 125% .
If 2 capsule are beyond +_ 15 % range, the test
is repeated using fresh 20 capsules. In retesting all
capsule should be in the range of +_ 25% (75%-
125%)
16. Moisture permeation Test
The degree and rate of moisture penetration is determined by packaging
the dosage unit together with a colour revealing desiccant pellet
Expose the packaged unit to known relative humidity over a specified
time
Observe the desiccant pellet for colour change
Any change in colour indicates absorption of moisture
By measuring pre test and protest weight of pellet. .amount can
be calculated
17. Bloom strength is a measure of cohesive
strength of cross-linkage that occurs between
molecules and is proportional to the molecule
weight of gelatin.
Higher the bloom strength,
more physically stable the capsule
shell .
Bloom range is 150 to 250 mg.
Bloom strength Of Gelatin
18. Gelatin is weighted into water to typically create a 6.67% solution in standard
bloom bottles.
The mix is then stirred and keep it for 3hr at room temperature.
Bottle are placed in 65⁰C bath for 20min. And bottle are removed from bath.
Allow the bloom bottle to cool for 15 min. at room temperature .they are
then conditioned for 16 hrs in 10⁰C water bath.
When conducting gelatin bloom test, the bloom bottle is centred
with the probe just above the sample surface.
The probe penetrates the gelatin to a target depth of 4mm at a speed
of 0.5mm/s and then retracts.
The peak force is gel strength in grams bloom
19. “:“”
• “Dr.Ashok .A. Hajare ,a Industrial pharmacy
-1 Textbook of , “Nirali prakashan” , third
edition ,page No.4.11 to 4.12.
• “ Leon Lachman Herbert A.Lieberman” , the
theory and practice of industrial
pharmacy,special Indian Edition 2009 , page
no.296 to 302.
References
