eTHiCaL DruGS LTD.

SIDDHIRGANJ, NARAYANGANJ
SPECIFICATIONS OF FINISHED PRODUCTS
Dept. Document No. ID Code Effective Date Version No. Page
Quality Control QC/SPE/FP050 FP050 01.01.17 01 1 of 1

Title : SPECIFICATION OF AMBEET CAPSULE

TEST : LIMIT
01. DESCRIPTION : A green TR/natural TR ‘1’ size hard gelatin capsule filled with
white SR spherical pellets.

02. IDENTIFICATION : Test must be positive for Ambroxol HCl

03. AVERAGE FILLED WEIGHT : 431.0 mg  1.0%

04. UNIFORMITY OF WEIGHT : As per BP

05. AVERAGE WT. OF SHELL : 69.0 to 85.0 mg

06. LOSS ON DRYING : NMT 3.0%

07. DISSOLUTION : Apparatus : Tablet/Capsule Dissolution Test Apparatus USP type-I

Medium
[
: 900 ml phosphate buffer pH 6.8
Agitation : 50 RPM
Temperature : 37.0 ± 1.0° C
1st Hour : 10.0% to 35.0%
4th Hour : 25.0% to 55.0%
8th Hour : 45.0% to 75.0%

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

09. STRENGTH : Each capsule contains Ambroxol HCl SR pellets equivalent to

75.0 mg of Ambroxol HCl

10. ASSAY : 90.0 to 110.0% of labeled amount of Ambroxol HCl

11. PACKING : 3  10’s PVDC Blister Strip in a box.
12. STORAGE : Keep in a cool and dry place protected from light.

…………………… …………………… ………………………

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/FP050 FP050 01.01.17 01 1 of 6

Title : TEST PROCEDURE OF AMBEET CAPSULE

01. DESCRIPTION : A green TR/natural TR ‘1’ size hard gelatin capsule filled with
white SR spherical pellets.
02. IDENTIFICATION : The UV/VIS absorption spectrum of the assay preparation is
correspondence to the spectrum of the Ambroxol HCl Working
Standard as in the assay.
03. AVERAGE FILLED WEIGHT : 431.0 mg  1%
Weigh an intact capsule. Open the capsule without losing any part
of the shell and remove the contents as completely as possible.
Weigh the shell. The weight of the contents is the difference
between the weighings. Repeat the procedure with another nineteen
capsules. Calculate the average weight as follow:
Total weight
Average weight = -------------------
Number (20)

04. UNIFORMITY OF WEIGHT :
Weigh an intact capsule. Open the capsule without losing any part
of the shell and remove the contents as completely as possible.
Weigh the shell. The weight of the contents is the difference
between the weighings. Repeat the procedure with another nineteen
capsules. Determine the average weight. Not more than two of the
individual weights deviate from the average weight by more than
7.5% and none deviates by more than twice of 7.5%.

05. AVERAGE WT. OF SHELL : 69.0 to 85.0 mg

Collect 20 shells randomly, weigh and record. Calculate the
average weight as follow:
Total weight
Average weight = -------------------
Number (20)
 …………………… …………………… ………………………
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/FP050 FP050 01.01.17 01 2 of 6

Title : TEST PROCEDURE OF AMBEET CAPSULE

06. LOSS ON DRYING : NMT 3.0%

Open 10 capsules and mix pellets. Take 1 gm of pellets and determine
by using a Digital Moisture Analyzer.

07. DISSOLUTION : Apparatus : Tablet/Capsule Dissolution Test Apparatus USP type-I

Medium : 900 ml phosphate buffer pH 6.8
[

Agitation : 50 RPM
Temperature : 37.0 ± 1.0° C
1st Hour : 10.0% to 35.0%
4th Hour : 25.0% to 55.0%
8th Hour : 45.0% to 75.0%

Standard Solution:
Dissolve 75.0 mg of Ambroxol HCl WS in methanol and dilute to
100 ml with the same solvent. Dilute 2 ml of the resulting solution
to 50.0 ml with Phosphate buffer pH 6.8 .

Sample Preparation:
Pour 900 ml of Phosphate buffer pH 6.8 in each dissolution flasks, and
assemble the apparatus. Allow the Phosphate buffer pH 6.8 medium
to equilibrate to a temperature of 37 ± 1°C. Put capsule in each basket
and operate the apparatus for 1 hour. At the end of 1 hour collect 10 ml
of sample from the dissolution flasks. Continue the operation for 8 hours.
After 4 hours and 8 hours collect the sample as same as 1 hour.
Dilute 10 ml of the each sample for different periods to 25.0 ml
with Phosphate buffer pH 6.8 respectively and filter.

Measure the absorbances of Standard and Sample solutions at 245 nm

using Phosphate buffer pH 6.8 as blank. Calculate the amount of Ambroxol HCl
dissolved in phosphate buffer pH 6.8 for different time intervals in % by the
formula:
 AU WS 2 900 25 Avg. Wt.
= ---------  --------- × ----------- × --------- × --------- × P  ------------ ×100
AS 100 50 WU 10 LC

…………………… …………………… ………………………

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/FP050 FP050 01.01.17 01 4 of 6

Title : TEST PROCEDURE OF AMBEET CAPSULE

Here,
AU = Absorbance of the Sample
AS = Absorbance of the Standard

WU = Weight of the Sample

WS = Weight of the standard
LC = Label Claim
P = Potency of the Standard used in percentage
Avg. Wt. = Average weight of the capsule
08. LEAK TEST : Should be 100.0% leak proof.
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.
09. STRENGTH : Each capsule contains Ambroxol HCl SR pellets equivalent to
75.0 mg of Ambroxol HCl
10. ASSAY : 90.0 to 110.0% of labeled amount of Ambroxol HCl
ASSAY : BY SPECTROPHOTOMETRY
PROCEDURE:
01. Std. Soln. :
Dissolve 100.0 mg of Ambroxol HCl WS in 50 ml of methanol and dilute to 100 ml
with the same solvent. Dilute 2 ml of the resulting solution to 50.0 ml with water.

…………………… …………………… ………………………

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/FP050 FP050 01.01.17 01 4 of 6

Title : TEST PROCEDURE OF AMBEET CAPSULE

02. Sample Soln. :

To a quantity of the mixed contents of 20 capsules containing the equivalent of 100 mg of
Ambroxol HCl add 50 ml of methanol, shake for 30 minutes and dilute to 100 ml with the
same solvent and filter. Dilute 2 ml of the filtrate to 50 ml with water.
03. Measure the absorbances for the Standard and Sample solutions at 245 nm using water
as blank. Calculate the content by the formula:

Content of Ambroxol HCl, in mg /Capsule

AU WS
= ---------  ---------  F  P  Avg. 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
Avg. Wt. = Average weight of the capsule

…………………… …………………… ………………………

Written by Checked by Approved by

QC Officer Sr. QC Officer QC Manager

Date : Date : Date :