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eTHiCaL DruGS LTD.

SIDDHIRGANJ, NARAYANGANJ
IN-HOUSE SPECIFICATIONS OF FINISHED PRODUCTS
Dept. Document No. ID Code Effective Date Version No. Page
Quality Control QC/SPE/FP003 FP003 01.01.17 01 1 of 1

Title : SPECIFICATION OF ETRATAB VET TABLET

TEST : LIMIT
01. DESCRIPTION : A yellow colored, oblong shape tablets having embossed
‘EDL’ on one side and a break line on another side.
02. IDENTIFICATION : Test must be positive for Oxytetracycline Hydrochloride

03. AVERAGE WEIGHT : 1420.0 mg  1.0%

04. UNIFORMITY OF WEIGHT : As per BP

05. LOSS ON DRYING : 4.0% to 5.0%


06. LENGTH : 23.5 to 23.6 mm
07. WIDTH : 12.7 to 12.8 mm
08. THICKNESS : 6.8 to 6.9 mm
09. HARDNESS : 3.0 to 5.0 Kg/cm2
10. PACKING : 3  6’s Blister Strip in a box.
11. STORAGE : Keep in a cool and dry place protected from light.
12. STRENGTH : Each bolus contains Oxytetracycline (as Oxytetracycline
Hydrochloride) BP(vet) 500 mg
13. ASSAY : 90.0 to 110.0% of labeled amount of Oxytetracycline

…………………… …………………… ………………………


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/FP003 FP003 01.01.17 01 1 of 3

Title : TEST PROCEDURE OF ETRATAB VET TABLET

01. DESCRIPTION : A yellow colored, oblong shape tablets having embossed


‘EDL’ on one side and a break line on another side.

02. IDENTIFICATION : The UV/VIS absorption spectrum of the assay preparation is


concordant with the spectrum of the Oxytetracycline
Hydrochloride Working Standard as in the assay.

03. AVERAGE WEIGHT : 1420.0 mg  1.0%


Collect 20 tablets randomly, weigh and record. Calculate the
average weight as follow:

Total weight
Average weight = -------------------
Number (20)

04. UNIFORMITY OF WEIGHT : Weigh 20 tablets selected at random and determine the average
weight. Not more than two of the individual weights deviate from
the average weight by more than 5.0% and none deviates by more
than twice of 5.0%.
05. LOSS ON DRYING : 4.0% to 5.0%
Powder 5 tablets and take 1 gm of powder. Determine the LOD
at 105º C by using a Digital Moisture Analyzer.

06. LENGTH : 23.5 to 23.6 mm


Check the length by using a Digital Slide Calipers or equivalent.
07. WIDTH : 12.7 to 12.8 mm
Check the width by using a Digital Slide Calipers or equivalent.
08. THICKNESS : 6.8 to 6.9 mm
Check the thickness by using a Digital Slide Calipers or equivalent.
09. HARDNESS : 3.0 to 5.0 Kg/cm2
Collect 10 tablets and check the hardness of the tablets by using
suitable hardness tester and record.
…………………… …………………… ………………………
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/FP003 FP003 01.01.17 01 2 of 3

Title : TEST PROCEDURE OF ETRATAB VET TABLET

10. LEAK TEST : Submerge 5 Strips in water containing 0.2% w/v methylene blue
or any suitable color in leak test Apparatus. Maintain the strips
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 strips. Wipe them to dry with clean dry
lint free cloth or tissue paper. De-foil the blister strips and observe for
blue spots/moistness/water inside the pockets.
If blue spots / moistness or water is not found inside the pockets, strips
are passed for the test.

11. STRENGTH : Each tablet contains Oxytetracycline (as Oxytetracycline


Hydrochloride) BP(vet) 500 mg
12. ASSAY : 90.0 to 110.0% of labeled amount of Oxytetracycline

ASSAY : BY SPECTROPHOTOMETRY
PROCEDURE:

01. Std. Soln. :


Dissolve 54.0 mg of Oxytetracycline Hydrochloride WS in 60 ml of 0.1 M Hydrochloric Acid
and dilute to 100 ml with the same solvent. Dilute 2 ml of the resulting solution to 100 ml with
0.1 M Hydrochloric Acid.

02. Sample Soln. :


Weigh and powder 10 tablets and dissolve powder equivalent to 50.0 mg of Oxytetracycline in 60
ml of 0.1 M Hydrochloric Acid and shake for 30 minutes. Dilute to 100 ml with the same solvent
and filter. Dilute 2 ml of the filtrate to 100 ml with 0.1 M Hydrochloric Acid.
03. Measure the absorbances for the Standard and Sample solutions at 271 nm using 0.1 M
Hydrochloric Acid as blank. Calculate the content by the formula:
…………………… …………………… ………………………
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/FP003 FP003 01.01.17 01 3 of 3

Title : TEST PROCEDURE OF ETRATAB VET TABLET

Content of Oxytetracycline, in mg /tablet

AU WS
= ---------  ---------  F  P  Av. Wt.
AS WU
Here,
AU = Absorbance of the Sample
AS = Absorbance of the Standard

WU = Weight of the Sample


WS = Weight of the Standard

F = Dilution factor
P = Potency of the Standard used in percentage
Av. Wt. = Average weight of the tablet
…………………… …………………… ………………………
Written by Checked by Approved by

QC Officer Sr. QC Officer QC Manager


Date : Date : Date :