IPQC and FPQC test for tablets according to IP,BP,USP.

1. Prepared by BHUMI P SURATIYA
First year Mpharm
Pharmaceutical Qualty Assurance
Semester 1
Pioneer Pharmacy Degree College, Vadodara

2. Content:-
1. INTRODUCTION
2. IN PROCESS QUALITY CONTROL
3. FINISHED PRODUCT QUALITY CONTROL
4. OBJECTIVE
5. IPQC FOR GRANULES AND POWDER
6. IPQC AND FPQC TEST FOR TABLETS
7. CONCLUSION
8. REFERENCES
2

3. INTRODUCTION:-
 Tablets is solid Pharmaceutical dosage form containing single
dose of one or more drug substances with or without suitable
diluents and prepared either by compression or molding
method, generally intended for oral administration.
 Quality is defined as "the degree to which something meets
or exceeds the expectations of its consumers." Quality is a
dynamic concept which is ultimately defined by customer
expectations and satisfaction.
• Quality is not an accident this is the result of intelligent effort.
3

4. Continued…
 Quality Control
ISO 9000 defines quality control as "a part of quality
management focused on fulfilling quality requirements".
• It is a part of GMP.
• To eliminate errors and production of end product of given
specification.
 In process quality control
 Finished product quality control
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5. In process quality control(IPQC)
 IPQC is concerned with providing accurate, specific and
definite description of the procedures to be employed from
the raw materials to the release of the finished dosage form.
 IPQC tests are performed at regular intervals (generally each
1 hr later) during the manufacturing process.
 In process quality control is a planned system to identify the
materials, equipments , process and operators.
5

6. Finished product quality control(FPQC)
 These are the test carried out after completion of product
manufacturing process.
 Qualitative and Quantitative analysis of product.
 Determine the test procedures and acceptance limit.
 To Monitor and improve effectively the whole applied
process at the every stage of the finished pharmaceutical
products by according to Standard Operating Procedures
(SOPs).
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7. Objectives:-
 To optimize the whole applied technological procedure.
 To monitor control and improve effectively the whole
applied operations at the every stage of the finished
pharmaceutical products.
 Inspection of raw material, equipment, environment,
process, testing with respect to specification, packing and
so on.
 Quality control & Process Control
7

8. IPQC And FPQC Tests:-
 Size and shape
 Colour and odour
 Unique identification
marking
 Loss on drying
 Thickness test
 Hardness test
 Friability test
 Weight variation
 Content uniformity
 Disintegration test
 Dissolution test
 Uniformity of mass
 Content of active ingredient
8

9. IPQC FOR GRANULES OR POWDER
1. Angle of repose
 The angle of repose – the angle between the slope of pile and
the radius cover by the powder or granules.
 The simplest method for determination is the “poured” angle.
 tanѲ = h/r
Where, Ѳ= angle of repose
h =height of pile
r =radius of pile
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10. Flow Properties and Corresponding
Angles of Repose
Flow Property Angle of Repose (degrees)
Excellent 25–30
Good 31–35
Fair 36–40
Passable 41–45
Poor 46–55
Very poor 56–65
Very very poor >66
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11. 2. Density
Density may influence compressibilty, tablet porosity and
dissolution.
i. Bulk densiy
Bulk density is defined as the mass of the many particles of
the material divided by the total volume they occupy.
pb= M/V
where, pb= Bulk density
M= weight of powder
V= volume of powder
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12. ii. Tapped or true density
Tapped density of a powder is the ratio of the mass of the
powder to the volume occupied by the powder after it has
been tapped for a defined period of time.
pt = M/Vt
Where, pt = tapped density
M= weight of powder
Vt= minimum volume occupied after tapping
iii. Percentage compressibility index (carr’s index)
A volume of powder is filled into a graduated glass cylinder
and repeatadly tapped for a known duration.The volume of
powder after tapping is measured.
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13. iv. Hausner ratio
Hausner ratio is a number that is correlted to the powder or
granular material. Is calculated by the formula,
H = tapped density/ bulk density
The hausner ratio is not an absolute property of a material; its
value can vary depending on the methodolgy used to determine
it.
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14. Compressibility
Index (%)
Flow Character Hausner Ratio
≤10 Excellent 1.00–1.11
11-15 Good 1.12–1.18
16-20 Fair 1.19–1.25
21-25 Passable 1.26–1.34
26-31 Poor 1.35–1.45
32-37 Very poor 1.46–1.59
>38 Very very poor >1.60
Scale of flowability
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15. Size and shape
 The size and shape of the tablet can be dimensionally described
monitored and controlled.
 It is determined by the tooling during the compression process.
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16. Colour And Odour
 Many pharmaceutical industry use colour as a vital means of
rapid identification and consumer acceptance. But it must be
uniform within a single tablet, from tablet to tablet and from
lot to lot.
 The presence of an odour in a batch of tablets could indicate a
stability problem
 e.g. the characteristic odour of acetic acid in degrading
aspirin tablets or could be characteristic of the drugs
 e.g. vitamins have a characteristic odor.
 Taste is important in consumer acceptance of chewable
tablets.
16

17. Unique Identification Markings
 Pharmaceutical companies often use some type of unique
markings on tablets in addition to color, for rapid identification
of their product.
 These markings utilize some form of embossing, engraving or
printing of the company name or symbol or a product code.
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18. Thickness test
 The thickness of a tablet is the only dimensional variable
related to the process.
 Tablet thickness should be controlled within a ± 5 % variation
of a standard.
 Thickness must be controlled to facilitate packaging.
 It is expressed in mm.
Vernier caliper 18

19. Hardness test
 The resistance of the tablet to chipping, abrasion or breakage
under conditions of storage, transportation and handling before
usage, depends on its hardness.
 For this test one of the earliest testers was Ketan tablet
hardness tester, which is a type of the Monsanto hardness tester
to evaluate tablet hardness.
 Limits:- 5 kilogram/cm² (minimum)
8 kilogram/cm² (maximum)
Monsanto type hardness
tester
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20. Friability test
 This property is related to hardness of tablets.
 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.
Friabilator
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21. Weight variation
 According to the USP this tablet is performed on 20 tablets by
calculating the average weights and comparing with the
individual tablet.
 The value of weight variation test is expressed in percentage.
 Formula for weight variation test:-
Weight Variation = (Iw - Aw)/Aw X 100%
Where, Iw = Individual weight of tablet
Aw = Average weight of tablet.
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22. AVERAGE MASS (mg) PERCENTAGE
DEVIATION
(%)
IP/BP USP
80 mg or less 130 mg or less ±10 %
More than 80mg
or less than
250mg
130 mg to 324
mg
±7.5%
250 mg or More More than 324
mg or More
± 5%
Table1: limits for weight variation
test as per IP, BP, USP
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23. Contant uniformity
 This test helps to ensure that the whether the content of tablet
is properly mixed or not. Content uniformity test is performed
randomly on 10 individual tablet.
 IP: Active less than 10mg or 10%
 BP: Active less than 2 mg or 2%
 USP: Active less than 5mg or 5%
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24. Disintegration test
 The disintegration test is used to show how quickly the tablet
break down into smaller particles, allowing for a greater
surface area and availability of the drug when taken by a
patient.
Disintegration
test apparatus
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25. Categories of tablets Disintegration time (min)
IP (min) BP
(min)
USP
Uncoated tablets 15 15 5-30 min.
Coated tablets 60 60 1 – 2 hrs
Enteric-coated tablets 60 - 1 hr or as per individual monograph
Film-coated tablets 30 - 30 min or as per individual monograph
Effervescent tablets 5 5 Less than 3 min or as per individual
monograph
Soluble tablets 3 3 -
Dispersible tablets 3 3 Less than 3 min or as per individual
monograph
Orodispersible tablets - 3 -
Gastro-resistant tablets - 60 -
Oral lyophilisates - 3 -
Table 2: Limits for disintegration times of
tablets as per IP, BP, USP 25

26. Dissolution test
 Dissolution testing measures the extend and rate of solution
formation from a dasage form
 The dissolution of a drug is important for its bioavailabilty
and therapeutic effectivness.
 In dissolution solid mass is transfer in liquid medium that is it
aqueous solubility dependent process
 More the aqeous solubility more is the dissolution.
Dissolution test
apparatus
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27. 27

28. Stage No. of tablet tested Acceptance criteria
S 1 6 Each unit is not less than
Q =5%
Q is the specified amount
of dissolved active
substance
S 2 6 Average of 12 units (S1+
S2) is equal to or greater
than Q, and no unit is
less than Q-15%
S 3 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 Q25%
Table 3: BP, USP, PhEur, JP and PhInt acceptance
criteria for dissolution test of tablet 28

29. CONCLUSION
 In process and finished product test are carried out so as we get
early warning of any error in the product and can be rectified soon.
 These in-process controls are necessary to ensure the quality of the
product. All the material should be tested during and after the
manufacturing process to control the quality of the product.
 it can be concluded that there is slight difference in, In-process
quality control tests of Indian pharmacopoeia; British
pharmacopoeia and united state pharmacopoeia.
 Some of the tests are not available in some pharmacopoeia.
 The product must be formulated according to the requirements
listed in corresponding pharmacopoeia.
 Different pharmacopoeia sets different limits for IPQC tests
Nevertheless; the main purpose of all pharmacopoeias is to
produce good quality pharmaceutical for human health. 29

30. References
1. Indian Pharmacopoeia Commission. Indian Pharmacopoeia. 7th
edition, Ghaziabad: Indian Pharmacopoeia Commission; 2007
2. British Pharmacopoeia Commission. British Pharmacopoeia, 13th
Edition, Stationery Office, Great Britain, 2013
3. Unites States Pharmacopoeia Convention. United States
Pharmacopoeia 38-National Formulary 33, Stationery Office, USA,
2010.
4. L Lachman, HA Lieberman, and JL Kanig: The Theory and Practice
of Industrial Pharmacy, Varghese publishing house 3rd Edition,
1986; 296-300.
5. In-process and finished products quality control tests for sterile and
non sterile dosage form: Int. J. Pharm. Sci. Rev., 45(1), July-August
2017;Article No. 40, Pages: 206,214
6. Chavan.et al Asian Journal of Pharmaceutical Research and Development.
2018; 6(3): 60-68 30

31. Thank you
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