Ophthalmic preparation are the sterile liquid or semisolid preparation meant to installation in to the eyes in the space between eye lids and eye ball . These product must be sterile and are prepare under the same condition as that of parenteral preparation

1. NOVEL IPQCL AND FPQC TEST FOR OPTHALMIC PREPARATION AS PER IP, BP ANIPQC D USP
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NATIONAL CONFERENCE:
A Phytomedicine: A Novel Approach For Cancer Treatment
Sponsered By
Indian Councial of Medical Research, Delhi.
Organised By
Kamla Nehru College of Pharmacy, Butibori, Nagpur 441108, Maharastra, India.
ON 25 & 26 March 2017
Conference Paper
NOVEL IPQCL AND FPQC TEST FOR OPTHALMIC PREPARATION
AS PER IP, BP ANIPQC D USP
Chitra Paytode1
, Roshan Telrandhe2
*
Dadasaheb Balpande College of Pharmacy, Nagpur, Maharashtra, India
Presented on 26 March 2017
Ophthalmic preparation are the sterile liquid or semisolid preparation meant to installation in to
the eyes in the space between eye lids and eye ball .
These product must be sterile and are prepare under the same condition as that of parenteral
preparation

2. NOVEL IPQCL AND FPQC TEST FOR OPTHALMIC PREPARATION AS PER IP, BP ANIPQC D US
2 | P a g e NATIONAL CONFERENCE: A Phytomedicine: A Novel Approach For Cancer Treatment
IPQCL AND FPQC TEST FOR OPTHALMIC PREPARATION AS PER IP, BP ANIPQC D US
NATIONAL CONFERENCE: A Phytomedicine: A Novel Approach For Cancer Treatment
IPQCL AND FPQC TEST FOR OPTHALMIC PREPARATION AS PER IP, BP ANIPQC D USP
NATIONAL CONFERENCE: A Phytomedicine: A Novel Approach For Cancer Treatment

3. NOVEL IPQCL AND FPQC TEST FOR OPTHALMIC PREPARATION AS PER IP, BP ANIPQC D US
3 | P a g e NATIONAL CONFERENCE: A Phytomedicine: A Novel Approach For Cancer Treatment
IPQCL AND FPQC TEST FOR OPTHALMIC PREPARATION AS PER IP, BP ANIPQC D US
NATIONAL CONFERENCE: A Phytomedicine: A Novel Approach For Cancer Treatment
IPQCL AND FPQC TEST FOR OPTHALMIC PREPARATION AS PER IP, BP ANIPQC D USP
NATIONAL CONFERENCE: A Phytomedicine: A Novel Approach For Cancer Treatment

4. NOVEL IPQCL AND FPQC TEST FOR OPTHALMIC PREPARATION AS PER IP, BP ANIPQC D US
4 | P a g e NATIONAL CONFERENCE: A Phytomedicine: A Novel Approach For Cancer Treatment
IPQCL AND FPQC TEST FOR OPTHALMIC PREPARATION AS PER IP, BP ANIPQC D US
NATIONAL CONFERENCE: A Phytomedicine: A Novel Approach For Cancer Treatment
IPQCL AND FPQC TEST FOR OPTHALMIC PREPARATION AS PER IP, BP ANIPQC D USP
NATIONAL CONFERENCE: A Phytomedicine: A Novel Approach For Cancer Treatment

5. NOVEL IPQCL AND FPQC TEST FOR OPTHALMIC PREPARATION AS PER IP, BP ANIPQC D US
5 | P a g e NATIONAL CONFERENCE: A Phytomedicine: A Novel Approach For Cancer Treatment
PARTICAL SIZE
 These test is applicable for
 Suitable volume of eye drops into a counting cell or onto a
corresponding to 10 microgram per ml of solid phase .
 According to IP Not more than 20 particles
micrometer .
 And not more than 10 particles
CONTENT UNIFORMITY :
As started by BP this test appropriate for
lotions are supplied in a dry , sterile from to be dissolved or suspended in an appropriate liquid
vehicle at the time of administration .
dispersion , to prevent the caking .
 10 dosage units taken at random.
 The preparation complies with the test if
the limits of 85 % to 115 %
%to 125 % average content .
IPQCL AND FPQC TEST FOR OPTHALMIC PREPARATION AS PER IP, BP ANIPQC D US
NATIONAL CONFERENCE: A Phytomedicine: A Novel Approach For Cancer Treatment
PARTICAL SIZE
These test is applicable for eye drops and eye ointment.
Suitable volume of eye drops into a counting cell or onto a microscope an area
corresponding to 10 microgram per ml of solid phase .
IP Not more than 20 particles have a maximum dimension greater than
10 particles have a maximum dimension grater than 50 micrometer
As started by BP this test appropriate for Powder for the preparation of eye drops
are supplied in a dry , sterile from to be dissolved or suspended in an appropriate liquid
vehicle at the time of administration . They may contain excipients to facilitate dissolution or
dispersion , to prevent the caking .
dosage units taken at random.
The preparation complies with the test if not more then one individual content is outside
85 % to 115 % of the average content and none is outside the limits of
average content .
IPQCL AND FPQC TEST FOR OPTHALMIC PREPARATION AS PER IP, BP ANIPQC D USP
NATIONAL CONFERENCE: A Phytomedicine: A Novel Approach For Cancer Treatment
microscope an area
have a maximum dimension greater than 25
50 micrometer.
eye drops and eye
are supplied in a dry , sterile from to be dissolved or suspended in an appropriate liquid
They may contain excipients to facilitate dissolution or
individual content is outside
is outside the limits of 75

6. NOVEL IPQCL AND FPQC TEST FOR OPTHALMIC PREPARATION AS PER IP, BP ANIPQC D US
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 The preparation fail , if one or more
115%of average content.
METAL PARTICLES IN OPTHALMIC PREPARATION
 Extrude as completely as practicable the content of 10 tubes individually into separate
,clear , flat- bottom , 60 mm petri
 Cover the dishes and heat
ensure that a fully fluid state is obtained.
 Taking precautions against disturbing the melted sample , allow each to cool to room
temp. and to solidify.
 Remove the covers and invert each petri
adjusted to furnish 30 times mag
disk that has been calibrated at the magnification being used .
IPQCL AND FPQC TEST FOR OPTHALMIC PREPARATION AS PER IP, BP ANIPQC D US
NATIONAL CONFERENCE: A Phytomedicine: A Novel Approach For Cancer Treatment
one or more individual contents are outside the limits of
METAL PARTICLES IN OPTHALMIC PREPARATION
completely as practicable the content of 10 tubes individually into separate
bottom , 60 mm petri-dishes that are free from scratches.
heat at 85 0c for 2 hrs. , increasing the temp. slightly if necessary to
a fully fluid state is obtained.
Taking precautions against disturbing the melted sample , allow each to cool to room
Remove the covers and invert each petri-dish on the stage of suitable microscope
adjusted to furnish 30 times magnification and equipped with an eye pieces micrometer
disk that has been calibrated at the magnification being used .
IPQCL AND FPQC TEST FOR OPTHALMIC PREPARATION AS PER IP, BP ANIPQC D USP
NATIONAL CONFERENCE: A Phytomedicine: A Novel Approach For Cancer Treatment
individual contents are outside the limits of 75% to
completely as practicable the content of 10 tubes individually into separate
. , increasing the temp. slightly if necessary to
Taking precautions against disturbing the melted sample , allow each to cool to room
dish on the stage of suitable microscope
nification and equipped with an eye pieces micrometer

7. NOVEL IPQCL AND FPQC TEST FOR OPTHALMIC PREPARATION AS PER IP, BP ANIPQC D US
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ISOTONICITY VALUE
 The term isotonic meaning equal tone .
 Cell neither swell nor shrink because there is no concentration gradient .
 Lachrymal fluid is isotonic with blood , having an
a 0.9% NACL Solution .
 Ideally an ophthalmic solution should have this isotonic value but eye can tolerate
isotonicity value as low as that of a
BUFFERING
 One purpose of buffering some ophthalmic solution is to prevent an increase in pH cause
by the slow release of hydroxyl ion by glass.
 Normal tears have a pH of about
 Rise in pH can affect both
 The application of solution to the eye stimulate the flow of tears and the rapid
neutralization of any excess hydrogen or hydroxyl ions within the buffer capacity of
tears.
FINISHED PRODUCT TEST FOR OPTHALMIC P
IPQCL AND FPQC TEST FOR OPTHALMIC PREPARATION AS PER IP, BP ANIPQC D US
NATIONAL CONFERENCE: A Phytomedicine: A Novel Approach For Cancer Treatment
The term isotonic meaning equal tone .
Cell neither swell nor shrink because there is no concentration gradient .
Lachrymal fluid is isotonic with blood , having an isotonic value corresponding to that of
Ideally an ophthalmic solution should have this isotonic value but eye can tolerate
as that of a 0.6% NACL and as high as that of a
One purpose of buffering some ophthalmic solution is to prevent an increase in pH cause
by the slow release of hydroxyl ion by glass.
of about 7.4 .
Rise in pH can affect both the solubility and stability of the drug .
The application of solution to the eye stimulate the flow of tears and the rapid
neutralization of any excess hydrogen or hydroxyl ions within the buffer capacity of
FINISHED PRODUCT TEST FOR OPTHALMIC PREPARATION
IPQCL AND FPQC TEST FOR OPTHALMIC PREPARATION AS PER IP, BP ANIPQC D USP
NATIONAL CONFERENCE: A Phytomedicine: A Novel Approach For Cancer Treatment
corresponding to that of
Ideally an ophthalmic solution should have this isotonic value but eye can tolerate
as that of a 2.0% NACL.
One purpose of buffering some ophthalmic solution is to prevent an increase in pH cause
The application of solution to the eye stimulate the flow of tears and the rapid
neutralization of any excess hydrogen or hydroxyl ions within the buffer capacity of

8. NOVEL IPQCL AND FPQC TEST FOR OPTHALMIC PREPARATION AS PER IP, BP ANIPQC D USP
8 | P a g e NATIONAL CONFERENCE: A Phytomedicine: A Novel Approach For Cancer Treatment
1. Sterility Test.
 Direct Inoculation Method.
 Membrane Filtration method.
2. clarity test.
 Visual Inspection.
 Instrumental Method .
3.Leaker Test.
4.Metal particles in ophthalmic ointment .
.
CLARITY TEST
 Ophthalmic solution by definition contain no undissolved ingredients and are essentially
free from foreign particles.
 VISUAL INSPECTION :
Under a good light , baffled against reflection into the eye and viewed against a black and white
background with content set in motion with swilling action .
INSTRUMENTAL METHOD :
It is utilizing the principle of light scattering , light absorption and resistance to obtain particle
count and size distribution .
Instrumental method utilizing video image projection detects moving particles without
destruction of product unit used for inline detection .
STERILITY TEST:
 Test must be carried out under aseptic condition design to avoid accidental contamination
of the product during testing.
 DIRECT INOCULATION METHOD :
It involves the direct introduction of product test samples into the culture media.
 MEMBRANE FILTRATION METHOD :

9. NOVEL IPQCL AND FPQC TEST FOR OPTHALMIC PREPARATION AS PER IP, BP ANIPQC D USP
9 | P a g e NATIONAL CONFERENCE: A Phytomedicine: A Novel Approach For Cancer Treatment
It involves filtering test sample through membrane filter , washing the fluid to remove inhibitory
property and transferring the membrane aseptically appropriate culture media.
Detection of contamination used to two culture media :
A. Soybean-casein digest medium : Incubated at 20 to 25 0c .
B. Fluid thioglycollate medium : Incubate at 30 to 35 oc on 7 days
LEAKER TEST
 Select 10 tubes of the ointment with seals applied when specified.
 Thoroughly clean and dry the exterior surface of each tube with an absorbent cloth.
 Place the tubes in horizontal position on a sheet of absorbent blotting paper in an oven
maintained at temperature of 60 oc for 8 hrs.
 No significant leakage occurs during or at the completion of the test.
 If leakage is observed from one , but more than one of the tubes repeat the test with 20
additional tubes of the ointment.
 The requires is met if no leakage is observed from the first 10 tubes tested or if leakage is
observed from not more than one of 30 tubes tested.
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10 | P a g e NATIONAL CONFERENCE: A Phytomedicine: A Novel Approach For Cancer Treatment
7. Nanotechnology for Cancer therapy: Recent developments
https://www.researchgate.net/publication/321669196_Nanotechnology_for_Cancer_thera
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ooth_Gel_from_Aloe_vera_leaves_extract
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erbal_Toothpaste_Compared_with_marketed_preparation
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erbal_Toothpaste_Compared_with_marketed_preparation
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11. NOVEL IPQCL AND FPQC TEST FOR OPTHALMIC PREPARATION AS PER IP, BP ANIPQC D USP
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