This document discusses in-process quality control (IPQC) tests for ointments. It describes IPQC as the process of controlling quality parameters during manufacturing from raw materials to final packaging. It then lists and describes 11 common IPQC tests conducted on ointments, including tests for appearance, drug content, pH, sensitivity, spreadability, absorption rate, extrudability, sterility, viscosity, medicament release rate, and uniformity of weight. The tests are designed to ensure the quality, safety and efficacy of ointment products during production.

1. Topic:- In Process Quality Control Test For Ointment
Subject Name :- Pharmaceutical Manufacturing Technology
Subject Code:- MQA204T
Department of Pharmaceutical Quality Assurance
Smt. B. N. B. Swaminarayan Pharmacy College, Salvav–vapi
Presented by:-
Machhi Dhruvi A.
2nd sem M.Pharm.

2. CONTENTS
• What is IPQC & IPQC Test
1. Appearance
2. Drug content determination
3. pH
4. Sensitivity test
5. Spreadability
6. Rate of absorption
7. Extrudability
8. Consistency Test
9. Rheology & Viscosity
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3. IN-PROCESS QUALITY CONTROL (IPQC)
 Quality is important in pharmaceutical dosage forms, for that we conduct various
tests to ensure quality efficiency and safety of product produced Form process which
we have to use in it.
 IPQC is the controlling procedure involved in manufacturing of dosage forms
starting from raw material purchase to dispatch in final packaging.
 So Qualitative and quantitative parameters of pharmaceuticals products was checked
by In-Process quality control (IPQC) Tests.
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4. IPQC TESTS
1. Appearance:
 Formulations were tested for physical appearance, texture, colour, phase
separation, & homogeneity.
 These parameters were evaluated by visual observation.
2. Drug content determination:
 Drug content determination involves the ointment having known weight is taken
& assayed for amount of the drug.
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5. 3. pH:
• Before filling for drug content checking of pH is required.
• From following standpoint, the pH of a formulation must be considered:
a. The effect on the body when the formulation is applied
b. The effect on stability of the product
c. The effect on container-closure system
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6.  pH meter is initially calibrated with respective buffer capsule (pH 4,7 & 9) then the
pH of the preparation is measured.
 The pH of formulations were determined by using digital pH meter.
 1 gm of ointment was dissolved in 100ml of distilled water & stored for 2 hours. The
measurement of pH was determined.
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7. 4. Sensitivity test:
 In this, when we use various types of ingredients with occasional use of antiseptics
hormones etc. there is a possibility of occurrence of sensitization or
photosensitization of the skin.
 This should be tested beforehand. This test is generally done by patch test.
 At different places the test sample is applied along with a standard market product &
after a period of time effect is compared.
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8. 5. Spreadability:
 Spreadability of the formulations was identified by measuring the spreading
diameter.
 To determine the Spreadability the ointment formulation of 1gm was placed between
the horizontal plates (20×20 cm2). After 1 minute, the upper plate was tied with a
standardized weight of 125gm.
 The time in which the upper glass slide moves over to the lower plate was taken as
measure of spreadability.
𝑆 =
𝑀. 𝐿
𝑇
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9. 6. Rate of absorption:
 The evaluation should be performed on ointment for the rate of absorption of drug
into the blood stream. The rate of absorption test can be run in-vivo only.
 Definite amount of ointments should be rubbed through the skin under standard
conditions as well as medicaments are estimated in the blood plasma or urine.
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10. 7. Extrudability:
 To determine the Extrudability of formulation the metal or aluminum collapsible tube
was filled with ointment formulation & the pressure was applied to the tube so that
extrusion of ointment takes place & it was checked.
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11. 8. Sterility Test:
 The test must be carried out under aseptic conditions designed to avoid accidental
contamination of the product during testing.
 Either of the following methods may be followed.
 Method A-Membrane Filtration or
 Method B- Direct Inoculation
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12. 9. Rheology & Viscosity:
 Ointments are marketed in tubes or containers so rheology is very important.
 The rheology or viscosity should remain constant.
 It can be measured using viscometers for non-Newtonian products.
 Rheological measurements are used to the ease of bottle pouring, squeezing from a
tube container, & maintaining product shape in a jar.
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13. 10. Rate of Release of Medicament:
• Small amount of the ointment can be placed on the surface of nutrient agar contained
to assess rate of release of medicament in a Petri dish.
• The agar plate is previously seeded with a suitable organism if the medicament is
bactericidal.
• The zone of inhibition is measured & correlated with the rate of release after a suitable
period of incubation.
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14. 11. Uniformity of weight:
• Select a sample of 10 filled containers & remove any labelling that might be altered in
weight while removing the contents of the containers.
• Clean & dry the outer surfaces of the containers and weigh each container.
• Remove quantitatively the contents from each container. If necessary, cut open the
container & wash each empty container with a suitable solvent, taking care to ensure
that the closure & other parts of the container are retained.
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15. REFERENCES
1. Indian Pharmacopoeia, 2014, volume-2, The Government of India, Ministry of
Health and Family Welfare, New Delhi, pp: 951-952
2. Jadhav Ankush P., Kedar Tejashree R., Datar Prasanna A., Jagtap Rushikesh N.,
& Jadhav Ravindra T., “New Approaches for Evaluation Test of Pharmaceutical
Dosage Forms”, International Journal for Research Trends and Innovation,
2020, Volume 5, Issue 10, 47-48.
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16. Thank you
…………..
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