IPQC TEST FOR OPHTHALMIC

PRODUCTS

By: Shikha Dubey (02)

Snehal Khankal (08)
 what are ophthalmic products

A sterile solution, suspension, or ointment for instillation into the eye

in the form of drops, sprays, and ointments.
Types of products:
Eye drops
Eye ointments
Eye lotions
Eye suspension
Contact lens solutions
Opthalmic Inserts
 Universal test for Opthalmics
Universal tests are the assessments that are implemented to all
ophthalmic products irrespective of the dosage form.
These tests include:
Identification
Description
pH test
Viscosity
Isotonicity
Therapeutic efficacy
Compatability with eye
Assay
1. Identification test: identification of the drug or drugs present
withinside the formulation.

2. Description: A qualitative description of the drug product must

be provided. The acceptance criteria should contain
the final appropriate appearance, which includes
clarity and color, of the dosage form and packaging

The eye can tolerate preparations over a range of pH

3. pH test: values from approximately 3.0 to approximately 8.6,
relying on the formulation buffer capacity.

An increase in viscosity will increase the residence time

4. Viscosity: in the eye. Ophthalmic ointments are designed to be of
very excessive viscous.
5. Isotonicity: The solutions must be isotonic .i.e. equivalent to 0.9%
sodium chloride solution

6.Therapeutic efficacy: The active ingredient(s) should be present

in the most therapeutically effective form

7. Compatability with eye: Ophthalmic solutions should be free

of chemicals or agents that cause
allergy or toxicity to the sensitive
membranes and tissues of the eye.

8. Assay: A unique and stability-indicating test has to be used to

decide the strength of the drug product.
 Quality control test:
Specific test for evaluation of opthalmic products.
1.Presence of metal particle:
This test is needed only for ophthalmic ointments. The presence of metal
particles will irritate the corneal or conjunctiva surface of the eye
. The bottom
Close the lid, and . The bottom surface of the
Take 10 ointment heat the product at surface is then ointment is
tubes, remove 85 c for 2 hr, once examined via examined and the
content from each melted and uniformly an optical amount of particles
tube onto a petri distributed allow it to microscope at 50mm or greater is
dish cool at room 30 times counted using a
temperature. magnification. calibrated eyepiece
micrometer.
2.Leakage test:
This check is carried out for an ophthalmic ointment to assess the intact
nature of the ointment tube and its seal.

10 sealed They are horizontally The check passes if

containers are located over absorbent leakage isn't always
chosen and their blotting paper in an oven found from any tube.
exterior surfaces saved at 60 ±three for • If leakage is
are cleansed eight hours. determined the test is
repeated with extra 20
tubes.
 3.Sterility test:
Sterility is a definite requisite of all ophthalmic formulations. Contaminated
ophthalmic formulations may also bring about eye infections that would in
the long run lead to blindness, especially if the Pseudomonas aeruginosa
microbe is involved.
The method used for sterility tests are
a. Direct transfer method
b. Membrane filtration method

a. Direct transfer method: Open each sample container and with draw the
require amount of the sample.
Inject one-half of sample in a test tube containing fluid Thioglycolate
Medium (FTM).
 Inject another half in the test tube containing Soyabean-casein digest
Medium(SCM).
Adequate mixing between the sample inoculums and the culture medium
must take place to maximize interaction and facilitate microbial growth.
If the product to be tested contains any anti-microbial agent, using suitable
reagent it should be neutralized before the test.
b. Membrane filtration method (MF):
This method is employed in the following cases:
1. Oil & oily preparations
2. Alcoholic preparations
3. For preparations miscible with or soluble in aqueous or oily solvents.
The steps involved in MF sterility test method are
i).The filter unit must be properly assembled and sterilized prior to use.
Ii).The contents are transferred to the filter assembly under strict aseptic
conditions.
iii) The membrane is removed aseptically.
iv). Membrane is cut in half.
iv) One half is place in suitable volume of FTM and another in an equal
volume of SCM.

Interpretation: - If no visible evidence of microbial growth in culture medium

in test tube then it is interpreted that the sample representing lot is without
intrinsic contamination.
 4.Particulate matter:
Ophthalmic preparations have to be free from foreign particles. This is carried
out by visual inspection under right light or with the aid of using instruments
which include light scattering or video image projection.

Visual inspection: - the

Instrumental method: - this
preparation is tested
technique makes use of the
under proper light, baffled
precept of light scattering,
against reflection into the
light absorption, and
eyes, and viewed against a
electric resistance to gain
black and white
particle count and size
background with content
distribution-destruction of
set in movement with a
product units.
swirling action.
 5.Uniformity of content
The test for uniformity of content of single-dose preparations is based
on the assay of the individual contents of active substance(s) of a
number of single-dose units to determine whether the individual
contents are within limits set with reference to the average content of
the sample
Single-dose powders for eye drops and eye lotions with a content of
active substance less than 2 mg, or less than 2% of the total taken at
random are determined individually

the preparation complies with the test if not more than one
individual content is outside the limits of +15% of the average
content and none is outside the limits of 25% of the average
content.s
 6.uniformity of volume
This complies with the tests for contents of packaged dosage forms.±
Select a sample of 10 filled containers, Clean and dry the outer
surfaces of the containers and weigh each container.

volume percentage deviation

<50 m ±9%

50-200 mL +4.5%

200-300 mL ±3%
7. uniformity of weight
This test is applicable to eye ointment Select a sample of 10 filled containers and
weigh each container. The contents from each container are removed
quantitatively.
Each empty container is weighed again.The average net weight of the contents of
the 10 containers is not less than the labelled amount and the net weight of the
contents of any single container is in the range of 19% of the labelled amount
where the labelled amount is 50 g
or less, or in the range of +4.5% of the labelled amount where the labelled is
more than 50 g but not more than 100 g
if this requirement is not met,
The average net weight of the contents of the 20 containers is not less than the
labelled amount, and the net weight of the contents of not more than 1 of the 20
containers is within ±9% of the labelled amount
where the labelled amount is 50 g; or in the range of ±5% of the labelled amount
is more than 50 g but not more than 100 g.
 8. bacterial endotoxin test
Endotoxins are the toxins which cannot diffuse through the bacterial cell
wall and are retained within the bacteria. They are released only when the
cells die and start disintegrating.
The test for bacterial endotoxins (BET) measures the concentration of
bacterial endotoxins that may be present in the sample or on the article
to which the test is applied using a lysate derived from the hemolymph
cells or amoebocytes of the horseshoe crab, Limulus polyphemus.
Other species of horseshoe crab namely Tachypleus gigas, Tachypleus
tridentatus and Carcinoscropius rotundicauda also yield amoebocyte
lysate having similar activity.
.
According to IP, the following methods can be used to monitor the
endotoxin concentration in a product official in the pharmacopoeia and to
determine whether the product complies with the limit specified in the
monograph:
Method A: Gel-Clot Limit Test Method
Method B: Semi-quantitative Gel-Clot Method
Method C: Kinetie Turbidimetric Method
Method D: Kinetic Chromogenic Method
Method E: End-Point Chromogenic Method
Case study: Carmellose Sodium Eye Drops
Description: Sterile colloidal solution

Content of drug: 95.0 - 115.0% of the stated

amount
Identification: a.by copper sulphate solution(gives blue, cotton
like ppt).
b. by assay using uv spectrophotometry.

Clarity : clear

pH: 6.0 TO 7.0

Osmolality: 270 to 350 mosmol/kg