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STP of Ethifen Syrup

The document provides specifications and test procedures for Ethifen Syrup 100 ml produced by Ethical Drugs Ltd., including tests for description, identification, filled volume, weight per ml, pH, foreign particles, leak testing, strength, and assay to ensure the finished product meets quality standards. The assay procedure involves preparing standard and sample solutions which are measured spectrophotometrically at 298 nm to calculate the ketotifen content and ensure it is within the 90-110% limit of the labeled amount.

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Bejoy Karim
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645 views5 pages

STP of Ethifen Syrup

The document provides specifications and test procedures for Ethifen Syrup 100 ml produced by Ethical Drugs Ltd., including tests for description, identification, filled volume, weight per ml, pH, foreign particles, leak testing, strength, and assay to ensure the finished product meets quality standards. The assay procedure involves preparing standard and sample solutions which are measured spectrophotometrically at 298 nm to calculate the ketotifen content and ensure it is within the 90-110% limit of the labeled amount.

Uploaded by

Bejoy Karim
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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eTHiCaL DruGS LTD.

SIDDHIRGANJ, NARAYANGANJ
SPECIFICATIONS OF FINISHED PRODUCTS
Dept. Document No. ID Code Effective Date Version No. Page
Quality Control QC/SPE/FP040 FP040 01.01.17 01 1 of 1

Title : SPECIFICATIONS OF ETHIFEN SYRUP 100 ML

TEST : LIMIT
01. DESCRIPTION : A clear, raspberry red colored, orange flavored syrup.
02. IDENTIFICATION : Test must be positive for Ketotifen Fumarate.

03. FILLED VOLUME : 100.0 ml ± 1.0 %


04. WEIGHT/ML : 1.0 to 1.1 gm/ml
05. pH : 4.5 to 5.0
06. FOREIGN PARTICLES : Should be absent

07. LEAK TEST : Should be 100% leak proof.


08. STRENGTH : Each 5ml contains Ketotifen (Ketotifen Fumarate) BP 1mg

09. ASSAY : 90.0 to 110.0% of labeled amount of Ketotifen

…………………… …………………… ………………………


Written by Checked by Approved by
QC Officer Sr. QC Officer QC Manager
Date : Date : Date :
eTHiCaL DruGS LTD.
SIDDHIRGANJ, NARAYANGANJ
TEST PROCEDURE OF FINISHED PRODUCTS
Dept. Document No. ID Code Effective Date Version No. Page
Quality Control QC/STP/FP040 FP040 01.01.17 01 1 of 3

Title : TEST PROCEDURE OF ETHIFEN SYRUP 100 ML

01. DESCRIPTION : A clear, raspberry red colored, orange flavored syrup.


02. IDENTIFICATION : The UV/VIS absorption spectrum of the assay preparation is
concordant with the spectrum of the Ketotifen Fumarate Working
Standard as in the assay.

03. FILLED VOLUME : 100.0 ± 1.0 ml


Check the filled volume of syrup by using a graduated 250 ml
Measuring Glass Cylinder.

04. WEIGHT/ML : The weight per ml of a liquid is weight in gm of 1 ml of a liquid when


weighed in air at 20º C.
Take weight of a clean and dried Pycnometer by using a Analytical
balance at 20 º C in air, express in gm. Now, fill the Pycnometer with
the liquid to be Written and take weight at the same conditions. Again
fill the Pycnometer with water and take weight in air, express in gm at

that temperature. Measure the capacity of the Pycnometer by deducting


the weight of the Pycnometer from the weight of the Filled Pycnometer
with water.

Determine the Wt/ml of the liquid by the formula;


W2 - W1
---------------
V
Here,

W1 = Weight of the Pycnometer in air, in gm at 20 º C

W2 = Weight of the Pycnometer filled with liquid in air, in gm at 20 º C

V = Capacity of the Pycnometer in ml


05. pH : 4.5 to 5.0
Take about 50 ml of syrup in a beaker and check pH of the syrup
by using a Digital pH Meter.
…………………… …………………… ………………………
Written by Checked by Approved by

QC Officer Sr. QC Officer QC Manager


Date : Date : Date :
eTHiCaL DruGS LTD.
SIDDHIRGANJ, NARAYANGANJ
TEST PROCEDURE OF FINISHED PRODUCTS
Dept. Document No. ID Code Effective Date Version No. Page
Quality Control QC/STP/FP040 FP040 01.01.17 01 2 of 3

Title : TEST PROCEDURE OF ETHIFEN SYRUP 100 ML

06. FOREIGN PARTICLES : Should be absent.


Gently swirl or invert each bottle, ensuring that air bubbles are not
introduced, observe for about 5 seconds in front of white panel, under light
having intensity of illumination 2000-3750 lux. Repeat the procedure in
front of the black panel.
07. LEAK TEST : Should be 100.0% leak proof.
Submerge 2 bottles in water containing 0.2% w/v methylene blue
or any suitable color in leak test Apparatus. Maintain the bottles
below the surface of water by means of a suitable device such as metal
disc or desiccator shelf. Apply the vacuum of 380 mm of mercury for
at least 2 minutes in the desiccator. Release the pressure slowly ﴾taking at
least 30 seconds﴿ and take out the bottles. Wipe them to dry with clean dry
lint free cloth or tissue paper. Open the bottles and pour the suspension
into a glass beaker. Observe the entrance of colored solution into the bottle
and mixing of colored solution with suspension.
If the entrance of colored solution into the bottle and mixing of colored
solution with suspension is not found inside the bottles is passed for
the test.

08. STRENGTH : Each 5ml contains Ketotifen (Ketotifen Fumarate) BP 1mg

09. ASSAY : 90.0 to 110.0% of labeled amount of Ketotifen


ASSAY : BY SPECTROPHOTOMETRY
PROCEDURE:
01. Buffer solution:
Dissolve 770 mg of Ammonium Acetate in water and dilute to 1000 ml with the same solvent.
Adjust pH of the solution to 3.0 with Phosphoric acid.
02. Diluent :
Mix 700 ml of Buffer solution pH 3.0 with 300 ml of methanol.

03. Std. Soln. :


Dissolve 138 mg of Ketotifen Fumarate WS in 60 ml of diluent and dilute to 100 ml with
the same solvent. Dilute 1 ml of the resulting solution to 100 ml with diluent.

…………………… …………………… ………………………


Written by Checked by Approved by

QC Officer Sr. QC Officer QC Manager


Date : Date : Date :
eTHiCaL DruGS LTD.
SIDDHIRGANJ, NARAYANGANJ
TEST PROCEDURE OF FINISHED PRODUCTS
Dept. Document No. ID Code Effective Date Version No. Page
Quality Control QC/STP/FP040 FP040 01.01.17 01 3 of 3

Title : TEST PROCEDURE OF ETHIFEN SYRUP 100 ML

04. Sample Soln. :


Dilute to 5 ml of syrup to 100 ml with diluent and filter.

05. Measure the absorbances for the Standard and Sample solutions at 298 nm using diluent as blank.
Calculate the content by the formula:

Content of Ketotifen, in mg /5 ml

AU WS
= ---------  ---------  F  P  5
AS VU
Here,
AU = Absorbance of the Sample
AS = Absorbance of the Standard

VU = Volume of the Sample


WS = Weight of the standard

F = Dilution factor
P = Potency of the Standard used in percentage
…………………… …………………… ………………………
Written by Checked by Approved by

QC Officer Sr. QC Officer QC Manager


Date : Date : Date :

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