Mixin Classes in Odoo 17 How to Extend Models Using Mixin Classes
IN-PROCESS QUALITY CONTROL TESTS - IPQC OF TABLETS ppt
1. INPROCESS QUALITY
CONTROL (IPQC) TEST FOR
TABLETS
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Prepared by:-
Akanksha Balasaheb Puri (01)
M pharmacy 1st Year
Department of Quality Assurance Techniques
3. INTRODUCTION
IPQC tests are tests that are carried out during the process of
manufacturing or before it is completed.
The function of the in-process quality control test is monitoring and if
necessary adaption of the manufacturing process in order to comply
with specification.
IPQC is concerned with providing accurate, specific and definite
description of the procedures to be employed from the receipt of raw
materials to the release of the finished dosage form.
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INTRODUCTION
4. IMPORTANCE OF IPQC TESTS
• To minimize human errors.
• To provide accurate, specific and definite description of the
procedure to be employed.
• Gives easier identification of the problems.
• Detects errors if and when it does occurs.
• Quality issues and unstable factors in manufacturing process
• Immediately takes measures to improve and ensures quality
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IMPORTANCE
5. TYPES OF THE IPQC TESTS
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PHYSICAL AND
CHEMICAL
BIOLOGIC AND
MICROBIOLOGIC
IDENTITY TEST
QUALITY TEST
PURITY TEST
POTENCY TEST
6. IPQC TEST FOR TABLETS
• OFFICIAL TESTS
1. WEIGHT VARIATION
2. DISINTEGRATION
3. DISSOLUTION
4. DRUG CONTENT
• UNOFFICIAL TESTS
1. GENERAL APPERANCE
2. HARDNESS
3. FRIABILITY
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7. UNOFFICIAL TESTS
• GENERAL APPEARANCE
- Its visual identity and all over elegance is essential for consumer
acceptance for control of lot of uniformity.
1. SHAPE
2. SIZE
3. COLOUR
4. ODOUR
5. TASTE
6. SURFACE TEXTURE
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8. The thickness of a tablet is the only dimensional variable related
to the process.
Thickness of individual tablets may be measured by a vernier
calliper.
Tablet thickness should be controlled within a ± 5 % variation of a
standard. Thickness must be controlled to facilitate packaging.
It is expressed in mm
• THICKNESS
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9. • HARDNESS TEST
Monsanto hardness tester is used to evaluate tablet hardness tester.
The tester consists of a barrel containing a compressible spring held between
two plungers.
The lower plunger is placed in contact with the tablet and zero reading is
taken.
The upper plunger is then forced against a spring by turning a threaded bolt
until the tablet fractures.
As the spring is compressed, a pointer rides along a gauge in the barrel to
indicate the force. The force of fracture is recorded in kilogram.
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10. • FRIABILITY TEST
For this test 20 tablets are weighed and placed in the friabilator and then
operated at 25 rpm for 4 minutes.
The tablets are then dedusted and weighed. The difference in the two weights is
used to calculate friability and the value of friability is expressed in percentage. It
is determined by the following formula.
Friability = (Iw – Fw)/Iw *100%
where, Iw = Total Initial weight of tablets;
Fw = Total final weight of tablets.
As stated by USP if conventional compressed tablets that loss less than 0.5
% to 1 % (after 100 revolutions) of their weight are generally considered
acceptable. 10
11. • Weight Variation Test
According to the USP 20 tablets were weigh randomly and average is taken. then
it is compared with upper and lower limit.
UPPER LIMIT= average weight + (average weight*% error)
Lower limit= average weight - (average weight*% error)
The value of weight variation test is expressed in percentage. The following
formula is used.
Weight Variation = ( Iw – Aw )/ Aw 100%
where, Iw = Individual weight of tablet
Aw = Average weight of tablet.
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OFFICIAL TEST
12. Sr no. Avg wt of tablets (mg) IP Max % difference allowed Avg wt of tablets (mg) USP
1 84mg or less 10% 130mg or less
2 84mg-250mg 7.5% 130mg-324mg
3 More than 250mg 5% 324mg or more
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13. • UNIFORMITY CONTENT
Randomly select 30 tablets.10 of these are assay individually.
The tablet pass the test if 9 of the tablets must contains not less than 85% and
not more than 115% of the labelled content and the 10th tablet may not contain
less than 75% and more than 125% of the labeled content
If the condition are not met, remaining 20 tablets assayed individually and more
may fall outside the 85-115% range.
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14. •DISINTEGRATION TEST
The USP disintegration apparatus consist of
6 glass tubes-3 inches long, open at the top, and held against a 10-mesh
screen at the bottom end of the basket rack assembly.
Temperature- 37 ± 2 °C (tablet remains 2.5 cm below the surface of the
liquid on their upward movement)
A standard motor driven device is used to move the basket up and down
through distance of 5 to 6 cm
Speed- 28 to 32 cycles per minute.
Perforated plastic discs may also be used in the test. These are placed on
the top of tablets and impart an abrasive action to the tablets.
Operate it for 15 mins. 14
15. Sr no. TYPES IP BP USP
1 Uncoated tablet 15mins 15mins 5mins
2 Sugar coated tablet 60mins 30mins -
3 Film coated tablet 30mins 30mins -
4 Enteric coated tablet 1hr in 0.1N HCl and
disintegrate in within 2hr
ion mixed phosphate buffer
6.8
1-2hr 2hr
5 Effervescent/dispersible tablet <3mins <3mins <3mins
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If any residue remains, it must have a soft mass. The tablet complies with the test
according to USP, if all of the tablets have disintegrated completely.
If 1 or 2 tablets fail to disintegrate completely, repeat the test on 12 additional
tablets. The requirement is met if not less than 16 of the total of 18 tablets tested
are disintegrated.
16. • DISSOLUTION TEST
It is generally used to determine the percentage release from the drug.
i.e breaks down into the smaller particle to get the increase surface area
Types of apparatus as per IP
Apparatus 1:Paddle type
Apparatus 2:Basket type
Conditioned maintain
Speed : 25-150rpm
Temperature: 37+_ 0.5 C
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17. Sr no. Stage
No. of tablet
tested
Acceptance criteria
1 S1 6 Each unit is not less than Q + 5 %.
2 S2 12
Average of 12 units (S1 + S2) is equal to or greater than Q,
and no unit is less than Q – 15 %.
3 S3 18
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 – 25 %
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