eTHiCaL DruGS LTD.

SIDDHIRGANJ, NARAYANGANJ
SPECIFICATIONS OF FINISHED PRODUCTS
Dept. Document No. ID Code Effective Date Version No. Page
Quality Control QC/SPE/FP055 FP055 01.01.17 01 1 of 1

Title : SPECIFICATIONS OF L-SOL SYRUP 60 ML

TEST : LIMIT
01. DESCRIPTION : A clear, pink colored, pineapple flavored syrup.
02. IDENTIFICATION : Test must be positive for Levosulbutamol Sulphate

03. FILLED VOLUME : 60.0 ± 1.0 ml

04. WEIGHT/ML : 1.1 to 1.15 gm/ml
05. pH : 4.5 to 5.5

06. FOREIGN PARTICLES : Should be absent

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

08. STRENGTH : Each 5ml contains Levosulbutamol Sulphate INN equivalent to
Levosulbutamol 1 mg

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

…………………… …………………… ………………………

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/FP055 FP055 01.01.17 01 1 of 4

Title : TEST PROCEDURE OF L-SOL SYRUP 60 ML

01. DESCRIPTION : A clear, pink colored, pineapple flavored syrup.

02. IDENTIFICATION : The retention time of the major peak of the test sample should be
concordant with the retention time of the Levosulbutamol Sulphate
Working Standard as in the assay.

03. FILLED VOLUME : 60.0 ± 1.0 ml

Check the filled volume of suspension by using a graduated 100 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 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 5.5
Take about 50 ml of suspension in a beaker and check pH of the
suspension 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/FP055 FP055 01.01.17 01 2 of 4

Title : TEST PROCEDURE OF L-SOL SYRUP 60 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 5 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 Levosulbutamol Sulphate INN equivalent to

Levosulbutamol 1 mg

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

ASSAY : BY HPLC
PROCEDURE:
01. Buffer Solution pH 3.0:
Dissolve 3.40 gm of Potassium Dihydrogen phosphate in 500 ml of water and adjust pH 3.0 with
phosphoric acid.

02. Mobile Phase:

 Mix 350 ml of buffer solution with 150 ml of Acetonitrile and adjust pH 3.0 with phosphoric acid.
Filter the mobile phase through a membrane filter having porosity 0.2 µ.

…………………… …………………… ………………………

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/FP055 FP055 01.01.17 01 3 of 4

Title : TEST PROCEDURE OF L-SOL SYRUP 60 ML

03. Standard Solution

Dissolve 140.0 mg of Levosulbutamol Sulphate Working Standard in Mobile phase and dilute to
100 ml with the same solvent. Dilute 1 ml of the resulting solution to 10 ml with mobile phase.
Filter the solution through a membrane filter having porosity 0.2 µ.

04. Sample Solution:

Dilute 5 ml of syrup to 10 ml with mobile phase and mix. Filter the solution through a
membrane filter having porosity 0.2 µ.

05. Chromatographic System :

a. Column : 250 × 4.6 mm, HAISIL 100 C18, 5µ
b. Detective Wavelength : 276 nm
c. Flow rate : 1.0 ml/min

d. Injection volume : 2 × 100 ml

e. RT : 4.0 min (approx.)

f. RSD : NMT 2.0%

06. Separately inject equal volumes of Std. Soln. and Sample Soln. into Chromatograph, record the
chromatograms and measure the peak responses for the major peaks. Calculate the content by the
formula:
Content of Levosulbutamol, in mg /5 ml
PU WS
= --------- ´ --------- ´ F ´ P ´ 5
 PS VU
Here,
PU = Peak area of the Sample
PS = Peak area of the Standard

…………………… …………………… ………………………

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/FP055 FP055 01.01.17 01 4 of 4

Title : TEST PROCEDURE OF L-SOL SYRUP 60 ML

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 :