eTHiCaL DruGS LTD.

SIDDHIRGANJ, NARAYANGANJ
SPECIFICATIONS OF FINISHED PRODUCTS
Dept. Document No. ID Code Effective Date Version No. Page
Quality Control QC/SPE/FP005 FP005 01.01.17 01 1 of 1

Title : SPECIFICATION OF TRIBEN-L VET BOLUS

TEST : LIMIT
01. DESCRIPTION : An almost most white, elongated bolus having embossed
‘ETHICAL’ on one side and a break line on another side.
02. IDENTIFICATION : Test must be positive for Triclabendazole and Levamisole HCl.

03. AVERAGE WEIGHT : 4200.0 mg  1.0%

04. UNIFORMITY OF WEIGHT : As per BP

05. LOSS ON DRYING : 5.0% to 6.0%

06. LENGTH : 39.0 to 39.1 mm
07. WIDTH : 15.0 to 15.1 mm
08. THICKNESS : 8.0 to 8.1 mm
09. HARDNESS : 3.0 to 6.0 Kg/cm2
10. PACKING : 5  4’s Blister Strip in a box.

11. ASSAY : 90.0 to 110.0% of labeled amount of Triclabendazole

90.0 to 110.0% of labeled amount of Levamisole

12. STORAGE : Keep in a cool and dry place protected from light.
13. STRENGTH : Each bolus contains Triclabendazole INN 900 mg and
Levamisole (as Levamisole Hydrochloride) BP 600 mg

…………………… …………………… ………………………

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/FP005 FP005 01.01.17 01 1 of 4

Title : TEST PROCEDURE OF TRIBEN-L VET BOLUS

01. DESCRIPTION : An almost most white, elongated bolus having embossed

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

02. IDENTIFICATION : In-house

03. AVERAGE WEIGHT : 4200.0 mg  1.0%

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

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

04. UNIFORMITY OF WEIGHT :
05. LOSS ON DRYING
Weigh 20 bolus 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%.
: 5.0% to 6.0%
Powder 5 bolus and take 1 gm of powder. Determine the LOD
at 105º C by using a Digital Moisture Analyzer.

06. LENGTH : 39.0 to 39.1 mm

Check the length by using a Digital Slide Calipers or equivalent.
07. WIDTH : 15.0 to 15.1 mm
Check the width by using a Digital Slide Calipers or equivalent.
08. THICKNESS : 8.0 to 8.1 mm
Check the thickness by using a Digital Slide Calipers or equivalent.
09. HARDNESS : 3.0 to 6.0 Kg/cm2
Collect 5 bolus and check the hardness of the bolus 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/FP005 FP005 01.01.17 01 2 of 4

Title : TEST PROCEDURE OF TRIBEN-L VET BOLUS

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 pockets.
If blue spots / moistness or water is not found inside the pockets, strips
are passed for the test.

11. STRENGTH : Each bolus contains Triclabendazole INN 900 and

Levamisole (as Levamisole Hydrochloride) BP 600 mg

12. ASSAY : 90.0 to 110.0% of labeled amount of Triclabendazole

90.0 to 110.0% of labeled amount of Levamisole

Assay for Triclabendazole:

PROCEDURE:

Weigh and powder 10 bolus. Transfer powder equivalent to 200 mg of Triclabendazole in a conical
flask and add 40 ml of Glacial Acetic Acid and shake to dissolve. Then add 2 drops of Crystal violet
solution as indicator. Titrate with 0.1 M Perchloric Acid VS to the end point.

Each ml of 0.1M Perchloric Acid VS is equivalent to 35.97 mg of Triclabendazole

Calculate the content by the formula:
Content of Triclabendazole, in mg /Bolus
 (V2-V1) × F× 35.97
= ------------------------- ´ Av. Wt.
Wt.

…………………… …………………… ………………………

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/FP005 FP005 01.01.17 01 3 of 4

Title : TEST PROCEDURE OF TRIBEN-L VET BOLUS

Here,
V1 = Initial burette reading
V2 = Final burette reading

F = Factor of the Volumetric Solution

Wt. = Weight of sample taken
Av. Wt. = Average weight of bolus

Assay for Levamisole:

PROCEDURE:

Weigh and powder 10 bolus. Transfer powder equivalent to 200 mg of Triclabendazole in a conical
flask and add 40 ml of Glacial Acetic Acid and 10 ml of mercuric Acetate and shake to dissolve. Then
add 2 drops of Crystal violet solution as indicator. Titrate with 0.1 M Perchloric Acid VS to the end
point.

Each ml of 0.1M Perchloric Acid VS is equivalent to 20.43 mg of Levamisole

Consumed volume by Levamisole = Consumed volume by Levamisole and Triclabendazole –

Consumed volume by Triclabendazole

=V

Calculate the content by the formula:

 Content of Levamisole, in mg /Bolus

V × F× 20.43
= ------------------------- ´ Av. Wt.
Wt.

…………………… …………………… ………………………

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/FP005 FP005 01.01.17 01 4 of 4

Title : TEST PROCEDURE OF TRIBEN-L VET BOLUS

Here,
V = Consumed volume by Levamisole

F = Factor of the Volumetric Solution

Wt. = Weight of sample taken
Av. Wt. = Average weight of bolus
…………………… …………………… ………………………
Written by Checked by Approved by

QC Officer Sr. QC Officer QC Manager

Date : Date : Date :