LABAID PHARMACEUTICALS LIMITED

Plant: 15, Genda, Savar, Dhaka-1340, Bangladesh.

STANDARD OPERATING PROCEDURE

TITLE: PREPARATION, STANDARDIZATION AND DEPARTMENT : Quality Assurance
HANDLING OF TEST SOLUTION AND VOLUMETRIC
SOLUTION SOP NO. : SOP/QC/005/02
VERSION NO. : 02
PAGE NO. : Page 1 of 8

ISSUE DATE : 07-October-2015 REVIEW DATE : 07-October-2018

EFFECTIVE DATE : 14-October-2015 SUPERSEDES : SOP/QC/005/01

REVIEW AND APPROVAL

Prepared by: Checked by: Approved by:

[Signature] [Signature] [Signature]

Name : Md. Shafiqul Islam Name : Md. Saiful Alam Name : Sukhi Karan

Job Title : Executive, Job Title : Asst. Manager, Job Title : AGM,
Quality Control Quality Assurance
Quality Control

Date : Date : Date :

DISTRIBUTION :

1. AGM, Quality Assurance (Original copy)

2. Quality Control

3 Analytical Laboratory
1. Purpose :

DO NOT MAKE A COPY OF THIS SOP. SOPs CAN ONLY BE COPIED BY THE HEAD OF QUALITY
ASSURANCE OR HIS/HER DESIGNATE.
 LABAID PHARMACEUTICALS LIMITED
Plant: 15, Genda, Savar, Dhaka-1340, Bangladesh.

STANDARD OPERATING PROCEDURE

TITLE: PREPARATION, STANDARDIZATION AND DEPARTMENT : Quality Assurance
HANDLING OF TEST SOLUTION AND VOLUMETRIC
SOLUTION SOP NO. : SOP/QC/005/02
VERSION NO. : 02
PAGE NO. : Page 2 of 8

The purpose of this procedure is to define the procedure for preparation and handling of test
solution and volumetric solution.
2. Scope :
This SOP is applicable for preparation of chemical reagent in QC Laboratory of general block at
Labaid Pharmaceuticals Ltd.
3. Definitions :
N/A
4. Responsibilities:
The roles and responsibility is as follows:

Roles Responsibility
 Ensure tests are performed with correct reagent as specified in
method.
 Ensure record of reagent preparation in the work sheet.
Sr. Executive/Executive,
 Ensure correct storage of reagent.
Quality Control
 Ensure use of reagent within the shelf life.
 Ensure reagents are retained until test results are approved.
 Ensure use of log book.
 Ensure reagents are in place and controlled.
 Assess and disposition of expired reagent.
Manager, Quality Control
 Maintain record.
 Application of sound technical knowledge.
 To ensure the overall implementation of the SOP.
AGM, Quality Assurance
 Approval of the SOP.

5. Revision Details:

Sl. No. Version no. Effective date Change History

01 01 02-February-2013 New SOP

02 02 14-October-2015  Title has been changed as ‘preparation,

standardization and handling of test solution and
volumetric solution’ instead of ‘standard operating
procedure for preparation of standard solution,
indicator solution, volumetric solution, general

Prepared by : Checked by :
 LABAID PHARMACEUTICALS LIMITED
Plant: 15, Genda, Savar, Dhaka-1340, Bangladesh.

STANDARD OPERATING PROCEDURE

TITLE: PREPARATION, STANDARDIZATION AND DEPARTMENT : Quality Assurance
HANDLING OF TEST SOLUTION AND VOLUMETRIC
SOLUTION SOP NO. : SOP/QC/005/02
VERSION NO. : 02
PAGE NO. : Page 3 of 8

Sl. No. Version no. Effective date Change History

reagent and standardization of volumetric solution’
 Change the content of the SOP
 Inclusion of annexure-I, annexure-II,
annexure-III, and annexure-IV,

6. Annexure:
 Annexure I: Test Solution Preparation Register
 Annexure II: Volumetric Solution Preparation and Standardization Register
 Annexure III: Label for Test Solution
 Annexure IV: Label for Volumetric Solution
7. Procedure:
Precaution(s):
 Wear protective clothing, gloves & goggles. Avoid contact with skin, eyes & clothing and
inhalation of vapour.
 Use a fume hood when preparing solutions.
 Read the label of reagent container for any special precaution.
7.1 General:
7.1.1 For the preparation of solution use purified water and analytical grade reagents and chemicals.
7.1.2 Prepare the solution as per respective approved worksheet.
7.1.3 Calculate the expiry date of solutions from the date of preparation.
7.1.4 Check the following things before preparation of any solution.
7.1.4.1 The glassware being used is clean and dried.
7.1.4.2 All required reagents are available.
7.1.4.3 All required instruments are calibrated.
7.1.4.4 Wear suitable safety appliances while making concentrated solutions of acid and alkali or any
hazardous chemicals.
7.1.5 General guideline for the preparation of Test Solution
7.1.5.1 Enter the details in the test solution preparation register (as per Annexure-I)
7.1.5.2 Assign sequential reference number as below:
e.g. G-TS-001/09/15
Where, G-TS is the abbreviation of General Block-Test Solution

Prepared by : Checked by :
 LABAID PHARMACEUTICALS LIMITED
Plant: 15, Genda, Savar, Dhaka-1340, Bangladesh.

STANDARD OPERATING PROCEDURE

TITLE: PREPARATION, STANDARDIZATION AND DEPARTMENT : Quality Assurance
HANDLING OF TEST SOLUTION AND VOLUMETRIC
SOLUTION SOP NO. : SOP/QC/005/02
VERSION NO. : 02
PAGE NO. : Page 4 of 8

001 is the sequential number

/ is separator
09 is the month of preparation (September)
15 is last two digits of year 2015
7.1.5.3 Affix respective label on the container as per Annexure-III.
7.1.5.4 Expiry date of test solutions will be 06 months or as per mentioned in worksheet. If during usage
any change in physical properties of the solution observed then discard the same.
7.1.5.5 If a solution is directed to prepare “fresh” , it must be prepared on the day of use
7.1.5.6 Discard the excess solution after expiry/ usage by diluting the solution with doubled quantity of
water and then drain it into the drainage, and make entry on the respective worksheet and
register.
7.1.6 General guideline for the preparation of volumetric solution
7.1.6.1 Analyst shall prepare all of volumetric solutions as per respective worksheet.
7.1.6.2 Enter the details in the volumetric solution preparation register (as per Annexure-II)
7.1.6.3 Assign sequential reference number as below:
e.g. G-VS001-001/09/15
Where, G-VS001 is the code no. of 0.1 M Ammonium thiocyanate VS for general block
001 is the sequential number
/ is separator
09 is the month of preparation (September)
15 is last two digits of year 2015
7.1.6.4 Affix respective label on the container as per Annexure-IV.
7.1.6.5 Volumetric solutions and standard solution for limit test must not be preserved for more than three
months. If during usage any change in physical properties of the solution observed then discard
the same.
7.1.6.6 Where stabilization time is not given, stabilize the solution for one hour before standardization.
7.1.6.7 Carry out standardization and calculate the factor of the solution twice, and RSD of two results
must be within 0.2%
7.1.6.8 Find out mean factor, which should be within ±5.0% of the labeled factor.
7.1.6.9 In case of factor of prepared solution found more than ±5.0% variation, do the necessary
dilutions/weight adjustments and carry out re-standardization. Report the factor upto four digits
after decimal.

Prepared by : Checked by :
 LABAID PHARMACEUTICALS LIMITED
Plant: 15, Genda, Savar, Dhaka-1340, Bangladesh.

STANDARD OPERATING PROCEDURE

TITLE: PREPARATION, STANDARDIZATION AND DEPARTMENT : Quality Assurance
HANDLING OF TEST SOLUTION AND VOLUMETRIC
SOLUTION SOP NO. : SOP/QC/005/02
VERSION NO. : 02
PAGE NO. : Page 5 of 8

7.1.6.10 Solution should be re-standardized in 1 month +3 days interval. In case, where extraneous
matters, layer separation or hazy solution observed then discard the same.
7.1.6.11 Assign re-standardization reference number as below:
e.g. Reference No./R1
Where, Reference No. of the volumetric solution subjected to re-standardization
/ is separator
R1 is re-standardization for first time (e.g. R1, R2…..)
7.1.6.12 Store all the solutions in cleaned dry containers and use amber color containers for light sensitive
solutions.
7.1.6.13 Discard the excess solution after expiry/ usage by diluting the solution with doubled quantity of
water and then drain it into the drainage, and make entry on the respective worksheet and
register.

Prepared by : Checked by :
 LABAID PHARMACEUTICALS LIMITED
Plant: 15, Genda, Savar, Dhaka-1340, Bangladesh.

STANDARD OPERATING PROCEDURE

TITLE: PREPARATION, STANDARDIZATION AND DEPARTMENT : Quality Assurance
HANDLING OF TEST SOLUTION AND VOLUMETRIC
SOLUTION SOP NO. : SOP/QC/005/02
VERSION NO. : 02
PAGE NO. : Page 6 of 8

Annexure-I
Test Solution Preparation Register

LABAID PHARMACEUTICALS LIMITED

Plant: 15, Genda, Savar, Dhaka-1340, Bangladesh.

Discarded
Sl. Name of Reference Date of Expiry Quantity Prepared Checked
by Remarks
No. Reagent No. Preparation Date Prepared by by
& Date

Annexure-II
Volumetric Solution Preparation and Standardization Register

LABAID PHARMACEUTICALS LIMITED

Plant: 15, Genda, Savar, Dhaka-1340, Bangladesh.

Name of Solution:
Code No. :

Prepared by : Checked by :
 LABAID PHARMACEUTICALS LIMITED
Plant: 15, Genda, Savar, Dhaka-1340, Bangladesh.

STANDARD OPERATING PROCEDURE

TITLE: PREPARATION, STANDARDIZATION AND DEPARTMENT : Quality Assurance
HANDLING OF TEST SOLUTION AND VOLUMETRIC
SOLUTION SOP NO. : SOP/QC/005/02
VERSION NO. : 02
PAGE NO. : Page 7 of 8
Prepared by

Quantity

Standardized by

Checked by

Checked by

Discarded by
Expiry Date

Re-Standardized by
Re-Standardization
Re-Standardized
Reference No.

Reference No.

Remarks
Sl. No.

Factor

Factor
Date
Prepared (mL)

& Date

& Date
& Date

& Date

Annexure-III
Label for Test Solution
LABAID PHARMACEUTICALS LIMITED
Plant: 15, Genda, Savar, Dhaka-1340, Bangladesh.
TEST SOLUTION
Reagent Name: __________________________________________________
Reference No.: ______________________ Hazard: ____________________
Strength: ___________________________ Quantity: ___________________
Preparation Date: ____________________ Expiry Date:_________________
Storage Condition: ________________________________________________
Prepared by: ________________________ Checked by: _________________

Annexure-IV
Label for Volumetric Solution

Prepared by : Checked by :
 LABAID PHARMACEUTICALS LIMITED
Plant: 15, Genda, Savar, Dhaka-1340, Bangladesh.

STANDARD OPERATING PROCEDURE

TITLE: PREPARATION, STANDARDIZATION AND DEPARTMENT : Quality Assurance
HANDLING OF TEST SOLUTION AND VOLUMETRIC
SOLUTION SOP NO. : SOP/QC/005/02
VERSION NO. : 02
PAGE NO. : Page 8 of 8

LABAID PHARMACEUTICALS LIMITED

Plant: 15, Genda, Savar, Dhaka-1340, Bangladesh.
VOLUMETRIC SOLUTION
Reagent Name: __________________________________________________
Reference No.: ______________________ Hazard: ____________________
Strength: ___________________________ Quantity: ___________________
Preparation Date: ____________________ Factor: _____________________
Standardization Date: _________________ Expiry Date: _________________
Re-standardization Date: ___________________________________________
Storage Condition: ________________________________________________
Prepared by: ________________________ Checked by: _________________

Prepared by : Checked by :