1. IPQC Tests for Capsules
as per I.P., B.P., U.S.P.
Prepared By: Pramod Ananda Ramane
P’ceutical Quality Assurance Department
Bharati Vidyapeeth College of Pharmacy, Kolhapur
M-Pharmacy, First Year
Roll No.-10 1

2. Contents
• Introduction
• What is IPQC?
• Why we need IPQC Tests?
• Who do IPQC Tests?
• IPQC Tests For Capsules:
1. Uniformity Of Content
2. Disintigration Test
3. Weight Variation Test
4. Dissolution Test
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3. • Capsules are solid dosage forms in which one or more medicinal and inert ingrédients are enclosed
in a Small Shell or container usually made of gelatin.
• The drug or amixture of drugs is enclosed in HardGelatin CapsuleShells,in soft, soluble shellsof gelatin, or
inhard or soft shells of anyother suitable material, of various shapesand capacities.
• Theyusually contain asingle doseof active ingredient(s) andare intended for oral administration.
• Excipientssuchasopaque fillers, antimicrobial preservatives,sweeteningagents, flavoring agentsand one or
more coloring agentspermitted under the Drugsand CosmeticRules,1945maybe added.
• Thecontents do not causedeterioration of the shell, but thecapsulesare attacked by the digestivefluids
thereby releasingthe contents. Thecontents of capsules other than Modified-release (Sustained-release)
Capsulesdo not contain any addedcoloring agent.
Introduction
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4. • 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, sipmle and rapid tests or inspection that carried out
at on going manufacturing .
• It is a planned system to identify the materials, equipment, process, andoperations.
What is IPQC ?
4

5. • To detect the errors
• To minimize the human errors.
• Provides accurate, specific, and definite description of the procedure to be
employed.
• Rigidly followed.
• Should detect any abnormality immediately and at the same time indicate the
kind of action needed to correct the problem.
• Toenforce the flow of manufacturing and packing operations according to
established routes and practice.
Why We Need IPQC Tests?
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6. IPQC Tests For Capsules:
• Uniformity Of Content
• Disintigration Test
• Weight Variation Test
• Dissolution Test
• Uniformity of Weight
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7. • This test is applicable to capsule that contain less than 10 mg or less than10 per cent w/w of
active ingredient (As per IP).
• This test is applicable to capsule that contain less than 25 mg or less than25
per cent w/w of active ingredient (As per BP/USP).
• For capsule containing more than one active ingredient carry out the testfor each active
ingredient that corresponds to the mentioned conditions.
• The test for Uniformity of content should be carried out only after the content of active
ingredient(s) in a pooled sample of the capsule has been shown to be within accepted limits of
the stated content.
• The test for Uniformity of content is not applicable to capsulecontaining
multivitamins and trace elements.
Uniformity Of Content
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8. • The preparation complies with the test if not more than one individual content is
outside the limits of 85 to 115 per cent of the average content and none is outside
the limits of 75to 125per centof the averagecontent.
• The preparation fails to comply with the test if more than three individual
contents are outside the limits of 85 to 115 per cent of the average content or if
one or more individual contents are outside the limits of 75 to 125 per cent of the
averagecontent.
• If two or three individual contents are outside the limits of 85 to 115 per
cent of the average content but within the limits of 75 to 125 per cent,
repeat the determination using another 20 dosage units.
• The preparation complies with the test if not more than three individual
contents of the total sample of 30 dosage units are outside the limits of 85
to 115 per cent of the average content and none is outside the limits of 75
to 125 per cent of the average content
Method
• Determine the content
of active ingredient(s) in
each of 10 dosage units
taken at random using
the method given in the
monograph or by any
other suitable analytical
method.
Acceptance limits
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9. • For the purpose of this test, disintegration does not imply complete solution of the dosage unit or even of its
active constituent.
• Disintegration is defined as that state in which no residue of the unit under test remains on the screen of the
apparatus or, if a residue remains, it consists of fragments of disintegrated parts of capsule component parts
such as insoluble coating of the of capsule shells, or of any melted fatty substance from the pessaries or
suppository or is a soft mass with no palpable core.
• If discs have been used with capsules, any residue remaining on the lower surfaces of the discs consists only
of fragments of shells.
• 28-32 cycle (strokes) per minute IP
• 29-32 cycle (strokes) per minute BP/USP
Disintegration Test
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10. • Unless otherwise stated in the individual monograph, introduce one capsule into each tube and,
if directed in the appropriate general monograph, add a disc to each tube. Suspend the assembly
in the beaker containing the specified liquid and operate the apparatus for the specified time.
• Remove the assembly from the liquid. The capsules pass the test if all of them have
disintegrated.
• If 1 or 2 capsules fail to disintegrate, repeat the test on 12 additional
capsules; not less than 16 of the total of 18 capsules testeddisintegrate.
• If the capsules adhere to the disc and the preparation under examination fails to comply, repeat
the test omitting the disc. The preparation complies with the test if all the capsules in the repeat
test disintegrate.
Method:
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11. Disintigration Test : For enteric-coated capsule
Method:
• If capsule having soluble external sugar coating, immerse the basketin
water at room temp for 5 min (USP).
• Put one capsule into each tube, suspend the assembly in the beaker containing 0.1M
hydrochloric acid and operate without the discs for(2 hour as per IP/BP) (1 hour as per USP)
, unless otherwise stated in the individual monograph. Remove the assembly from the liquid.
• No capsule shows signs of cracks that would allow the escape of the contents or
disintegration, apart from fragments ofcoating.
• Replace the liquid in the beaker with mixed phosphate buffer pH 6.8,add a disc to each tube and
operate the apparatus for a further 60minutes.
• Remove the assembly from the liquid. If the capsule fails to comply because of adherence to
the disc, repeat the test on a further 6 capsule without the discs. The capsule pass the test if all
six havedisintegrated.
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12. Disintegration testing condition and interpretation (IP)
Sr.
No
Type of capsule Medium Temperature Limit
1 Hard gelatin Water/buffer 37 °± 2 °C 30 min or as per individual
monograph
2 Soft gelatin Water 37 °±2 °C 60 min or as per individual
monograph
3 Enteric-coated 0.1 M HCl
mixed
phosphate buffer
pH 6.8
37 °±2 °C 02 hour in HCl: no disintegration
60 min in buffer : disintegrate
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13. Disintegration testing condition and interpretation (BP)
Sr.
No
Type of capsule Medium Temperatu
re
Limit
1 Hard gelatin Water/0.1 M
HCl/Artificial
gastric juice R
37 °± 2 °C 30 min or as per individual
monograph
2 Soft gelatin Water/0.1 M
HCl/Artificial
gastric juice R
37 °±2 °C 60 min or as per individual
monograph
3 Enteric-coated 0.1 M HCl
mixed
phosphate
buffer pH 6.8
37 °±2 °C 02 hour in HCl: no disintegration
60 min in buffer : disintegrate
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14. weigh 20 capsules individually and determine the avg weight
The individual wts should be with in limit of 90-110% of avg wt
If not all of capsules fall with in the limits,
Weigh 20 capsules individually
Remove the net content of each capsule with the aid of a small brush
Weigh the empty shells individually
Determine the average net content from the sum of individual net weight
Weight Variation : For Hard Gelatin Capsules
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15. Then determine the difference b/w each individual net
content and average net content
NET WEIGHT OF CONTENTS INDIVIDUALLY = THE WEIGHT OF SHELL-GROSS WEIGHT
Not more then 2 of the differences are greater then 10% of the avg net content
Limits:
No case is the difference greater then 25% weight range
If more then 2 ,but not more then 6 capsules deviate from the average b/w 10-25%
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16. weigh the capsules individually then cut and open the capsules
remove the contents by washing with the suitable solvent
allow the solvents to evaporate from the shells at room temp
weigh the individual shells
Weight Variation : For Soft Gelatin Capsules
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Calculate the Net Content
Average Weight of Capsule Percentage Deviation
Less than 300 mg 10
300 mg or more 7.5

17. Dissolution Test
• The dissolution test is carried out using the dissolution apparatus official in the I.P., B.P. and
U.S.P.
• The capsule is placed in a basket , and the basket is immersed in the dissolution
medium and caused to rotate at a specified speed .
• The dissolution medium is held in a covered 1000ml glass vessel and maintained at 370c +-0.5 0Cby
means of a constant temperature suitable water bath .
• The stirrer speed and type of dissolution medium are specified in the individual
monograph .
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• Indian Pharmacopoeia- Type II Apparatus (Basket)
• B.P./U.S.P.- Type I Apparatus (Basket)

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Sr.no. Quantity
Stage/level
Number of Capsules
tested
Acceptance criteria
1 S1 6 Each unit is not less than D* + 5
percent**
2 S2 6 Average of 12 units (S1
+S2) is equal to or greater than (> )D, and no
unit is less than D - 15 percent**
3 S3 12 Average of 24 units (S1+S2+S3) is equal to
or greater than (> )D, not more than 2 units
are less than D-15 percent** and no unit is
less thanD- 25 percent**
Dissolutiontesting interpretation IP Standard
*D is the amount of dissolved active ingredient specified in the individual monograph

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Sr.no. Quantity
Stage/level
Number of Capsules
tested
Acceptance criteria
1 S1 6 Each unit is not less than Q + 5 percent**
2 S2 6 Average of 12 units (S1
+S2) is equal to or greater than (> )Q, and no
unit is less than Q - 15 percent**
3 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 percent** and no unit is
less thanQ- 25 percent**
Dissolutiontesting interpretation BP/USP Standard
*The quantity Q, is the specified amount of dissolved active substance.

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Tests IP BP USP
Drug Content Uniformity 85 – 115% 85-115% 90-110%
Content uniformity 85 - 115% 85 - 115% 85 - 115%
Weight uniformity <300mg=10%
>300mg=7.5%
<300mg=10%
>300mg=7.5%
NS
Disintegration test Disintegration time
Hard Gelatin < 30min < 30min <30 min
Soft Gelatin < 60 min < 60 min < 60 min
Enteric coated 2hr in HCl
60min. In Buffer
2hr in HCl
60min. In Buffer
NS
Gastro Resistent 60 60 60
Dissolution test > 70% > 70% > 70%
Comparison Of Specifications & Parameters

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• In process controls (IPC) are checks that are carried out
before the manufacturing process is completed.
• In process materials should be tested for their physical parameters and its quality
attributes which are later approved or rejected by the quality control department
based on the results obtained during the manufacturing process.
• Standard operating procedures should be established andfollowed that describe the in
process controls and tests.
• In process controls may be performed at regular intervals during a process or at the end
of the process.
Conclusion:

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References:
1. Indian Pharmacopoeia- 2018
2. British Pharmacopoeia -2014
3. United States Pharmacopoeia- 2014

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