SOP for Preparatation and Standardization of Volumetric Solution

1.0   Objective:

               To provide written procedure for preparation and Standardization of volumetric     solutions.    

2.0          Scope:

               This SOP covers preparation, standardization, re-standardization frequency and storage conditions of volumetric solution.

3.0          Responsibility:

Jr. Research Officer/Research officer: Responsible for Preparation, standardized and maintenance of solution.

QA Officer/QA Manager: Review the records and governing the document.

4.0          Procedure:

4.1          The volumetric solutions are classified in two categories, Category A and Category B.

Category A includes all the solutions which are to be re-standardized after 15 days ± 2 days.

4.2          Category B includes all the solutions to be standardized prior to use.  

4.3          The validity period for both the category of volumetric solution shall be one month from the date of preparation.

4.4          Volumetric solutions are prepared as per the respective method of preparation given in file method for preparation and Standardization of volumetric solution.

4.5          Record the details of preparation.

4.6          Use previously dried primary standards for Standardization.

4.7          Volumetric solutions shall be standardized as per the procedure given in file method for preparation and Standardization of volumetric solution.

4.8          When the solution is to be used in assay in which the end point is determined by an electrochemical process, the Standardization of the solution shall be performed in the same way.

4.9          Standardization shall be done in triplicate and average of three readings shall be considered for further use.

4.10        Precision of the Standardization shall not be more than 0.2 %.     

4.11        Volumetric solutions do not differ from the prescribed strength by more than 5.0 %.

4.12        Volumetric solution shall be prepared & standardize as per the approved method and same shall be recorded in its worksheet. The preparation shall be documented in the log book as per Annexure – 5.

4.13                   Each preparation of volumetric solution shall be assigned unique A.R No. as per the procedure described as under for traceability.

V/ 001/DD/MM/YY

Where V stands for volumetric solution

001 is the Identification Number of volumetric solution.

DD stand for the date on which the solution is prepared.

MM stands for the month in which solution is prepared.

YY stand for year 2011 i.e. 11

4.14          Affix a label on the bottle of the volumetric solution as per Annexure – 1.

4.15        Record the details of preparation and standardization and re-standardization as given in Annexure – 2 

4.16        For storage condition Re-standardization frequency refer Annexure – 3.

5.0          Precautions:

5.1          Use purified water for preparation of volumetric solutions.

5.2          Use double distilled water for the preparation of Silver nitrate solution.

5.3          Use boiled and cooled water for unstable solution such as potassium permanganate and sodium thiosulphate solution.

6.0          Documentation:

6.1          Annexure – 1    - Label for bottle of the volumetric solution   XXX/FRM/000-00

6.2          Annexure – 2    - preparation, standardization & re-standardization of the volumetric      solution       XXX/FRM/000-00        

6.3          Annexure – 3    - Storage condition, Category of volumetric solution  XXX/FRM/000-00            

6.4   Annexure –4 - Log book for preparation and standardization of volumetric solutions     XXX/FRM/000-00

7.0       History of Revision:

Revision No.	Effective Date	Revision details	Reason for revision
01	DD/MM/YEAR	Add revision history and defined responsibility.	Periodic review

ANAXATURE 1

Volumetric Solution	LABEL FOR CATEGORY A SOLUTION
	Name of the Solution :
	A.R.No.:
CATEGORY A Standardization frequency : 15 + 2 days.	Prepared On:		Valid Up to:
	Date	Molarity	Use Before	Done By
	Storage Condition:  Room Temperature

Volumetric Solution	LABEL FOR CATEGORY B SOLUTION
	Name of the Solution :
	A.R.No.:
CATEGORY B Standardization frequency : Prior to use.	Prepared On:		Valid Up to:
	Date	Molarity		Done By
	Storage Condition:  Room Temperature.

      



Annexure 2
Preparation , Standardization & RE-Standardization of the Volumetric Solution                                

Name of the Solution	:						Category	:
A.R.No.	:
Preparation			Standardization
Date of Preparation	:		Date of Standardization			:
Batch No.	:		Use before			:
Make	:		Batch No. /A.R.No.			:
Balance ID	:		Make			:
Balance Cal. Due on	:		Balance ID			:
Sol. Valid up to	:		Balance Cal. Due on			:
Preparation Method:
Standardization:           1                                        2                                                           3
Wt of Primary Std.   :                                gm Volume taken          :                                ml Burette Reading        :                                ml		Wt of Primary Std.   :                                gm Volume taken          :                                ml Burette Reading        :                                ml			Wt of Primary Std.   :                                gm Volume taken          :                                ml Burette Reading        :                                ml
Formula:
Calculation:		Calculation:			Calculation:
Molarity:		Molarity:			Molarity:
Mean Molarity :
Precision:	± 0.2% (NMT)
Observed Precision
Analysed By:				Checked By:

Name of the Solution	:				Category	:
Re-Standardization
Date of Standardization			:
Use before			:
Sol. Valid up to			:
Batch No. /A.R.No.			:
Make			:
Balance ID			:
Balance Cal. Due on			:
Re-Standardization
1                                                              2                                                     3
Wt of Primary Std.   :                                gm Volume taken          :                                ml Burette Reading        :                                ml		Wt of Primary Std.   :                                gm Volume taken          :                                ml Burette Reading        :                                ml		Wt of Primary Std.   :                                gm Volume taken          :                                ml Burette Reading        :                                ml
Formula:
Calculation:		Calculation:		Calculation:
Molarity:		Molarity:		Molarity:
Mean Molarity :
Precision:	± 0.2% (NMT)
Observed Precision
Analysed By:			Checked By:

Annexure – 3 LIST OF VOLUMETRIC SOLUTIONS
Sr. No.	Name of the solution	Storage Condition	Category

Annexure – 4

LOG BOOK FOR PREPARATION AND STANDARDIZATION OF VOLUMETRIC SOLUTION

S.No.	Name of the Volumetric Solution	A.R.No.	Date of Preparation	Valid upto	Prepared By	Checked By