In Process And Final Product Quality Control Test For Capsules
1. SMT R.D Gardi B.Pharmacy College Nyara ,Rajkot
Presented By- Akshita Dholakiya
B.Pharm
Guided By- Kajal Pradhan
Assistant professor
M.Pharm(pharmaceutics)
In Process And Final Product Quality Control
Test For Capsules
(Soft And Hard Gelatin)
3. Introduction
Definition: According to IP the In process quality
control is a process of monitoring critical variables
of manufacturing process to ensure a quality of the
final product.
• IQPC test are performed at regular intervals
(generally each 1hr later) during the manufacturing
process.
• These tests are vary from dosage form to dosage
form.
3
4. Why we perform In-Process Quality Control?
To optimize the technological procedure used in
manufacturing process.
To monitor, control and improve effectively the whole
applied operations at every stage of the finished
pharmaceutical products.
Inspection of raw material, equipment, environment,
process, testing with respect to specification, packing,
etc.
Quality and process control.
4
6. Hard gelatin capsule: It is a type of capsule
consist of dry powder,granules or very
small pellets. Also called as hardgel shells.
• It consist of two parts capsule body and
capsule cap.
Eg:Ampicillin capsule,omeprazole capsule.
Soft gelatin capsule: It consist of a gelatin
based shell surrounding a liquid or
semisolid fill. Also called as softgel shells.
Eg: vitamins And mineral capsules
6
7. IPQC Test
Physical Test
1) Disintegration test
2) Weight variation test
Chemical Test
1) Dissolution test
2) Assay
3) Content uniformity test
4) Content of Active Ingredients
5) Stability testing
6) Moisture permeation test
7
8. Chemical test
1.Dissolution test
8
• Dissolution testing measure the extent and rate of solution
formation from a dosage form, such as
tablet,capsule,ointment etc .
• The dissolution of a drug is important for its bioavailability
and therapeutic effectiveness.
Dissolution test apparatus by s.v
scientific technologies
9. stage Number of capsule tested Acceptance criteria
S1 6 Each unit is not less than Q+5%
S2 6 Average of 12 units (S1+S2) is equal to or
greater than Q and no unit is less than Q-15%
S3 12 average of 24 units(S1+S2+S3) is equal to or
greater than Q not more than 2 units are less
than Q-15% and no unit is less than Q-15%.
Acceptance criteria for dissolution test of capsule
9
10. • Identification : this test identifies the API in the pharmaceutical
capsule. This test should be able to identify the compounds of closely
related structure that are likely to be present.
• Assay:This test determines the strength or content of the API in the
pharmaceutical capsule and it s also called as content test
.
• Impurities: This test determines the presence of any component that
is not the API or excipients of pharmaceutical tablet. The process
impurities is the most common type of impurities. That are arises from
the new drug substance synthesis, degradation products of the API.
• Appearance: Appearance of capsule must be uniform. For detect of
any flaws in the integrity and appearance of the capsule, visual or
electronic inspection should be undertaken
10
11. • Content of Active Ingredients: For this test a sample of the contents is assayed as
described in individual monographs and calculates the amount of active ingredient in each
capsule.
20 capsules, or such other number as may be indicated in the monograph, are used in the
assay. In the circumstances where 20 capsules cannot be obtained, a smaller number, which
must not be less than 5
• Size and Shape: Hard capsules- made in a range of sizes, the standard industrial range of size
for capsule is from 000 (the largest, 1.40 ml) to 5 (the smallest, 0.13 ml) are commercially
available
Soft gel capsules-available in variety of shapes and size such as spherical (0.05–5 ml), ovoid
(0.05–7 ml), cylindrical (0.15– 25 ml), tubes (0.5–0 ml), pear (0.3–5 ml) etc
.
11
13. Content Uniformity Test
• Uniformity of content is a pharmaceutical analysis parameter for the quality
control of capsule
• Multiple capsules are selected at random and suitable analytical method is
applied to assay the individual content of active ingredient in each capsule
14
15. Stability testing
Stability testing of capsules is performed to determine the
physicochemical stability of the drug substance in the finished
drug product under specified package
In recommended storage conditions intrinsic stability of the
active drug molecule and the influence of environmental factors
(e.g., temperature, humidity, light), on formulation components,
and the container and closure system.
The test is performed to find out the integrity of capsule shell.
16
Marshall stability test apparatus
16. Test conditions Observation
80% RH at room temperature in an open container Capsule are observed periodically for 2 weeks, both
gross and subtle effects of the storage conditions are
noted and recorded. The control capsule should not
be affected except at the 80% RH station.
40°C in an open container.
40°C in a closed container(glass bottle with tight
screw-cap.)
Test conditions for accelerated stability tests for capsule dosage forms
17
17. Moisture permeation test
• This test is carried out to assure the suitability of containers for packaging of capsule .
• The degree and rate of moisture penetration of containers are determined by packaging the
dosage unit together with color revealing desiccant pellet.
18
Labthink W3/030 moisture permeation tester
18. Microbial contamination
The capsules are tested to ensure
lack of growth of bacteria and
mould by microbiological tests.
These tests are usually carried out
by incubation of the capsule
contents in a growth medium and
counting the colonies formed after
a predefined period of time.
Selection of the growth medium
and duration of the test, as well as
maintenance of aseptic conditions
during the testing, are critical to
successful assessment of microbial
contamination by this method.
19
19. Physical Test
• The disintegration test determines the ability of a capsule to break down into
smaller particles or granules disintegrate within prescribed time.
1) Disintegration Test
20
Disintegration apparatus
21. Weight variation test
• Weight variation test is also known as uniformity of weight, it is the official
quality control test which is performed to ensure that each tablet dosage form
has the accurate amount of drug.
• The test is conducted by weighing 20 tablets individually on an analytical
balance, computing the average weight, and comparing the individual weights of
the tablet to the average.
22
22. 23
Number of capsule
Average net weight of capsule Deviation(%)
Less than 300 mg0 mg
300mg and more
±10.0
±7.5
±15.0
Minimum 18
Maximum 2
Minimum 18
Maximum 2
±20.0
Standard limits of avg. weight of capsule according to I.P
23. Reference
• Lachman /Lieberman’s the Theory and Practice of industrial Pharmacy
Fourth Edition
• Indian pharmacopoeia eighth edtion (IP 2018)
• British pharmacopoeia(BP2019)
• PV publication industrial pharmacy-1 by Dr Shalini sharma.
• https://pharmapathway.com/process-quality-control-review/
• https://www.researchgate.net
• https://en.wikipedia.org
• Images source - google.com 24
