I.
PURPOSE :
To provide a methodology for the preparation, standardisation / re-
standardisation
II.
and to provide expiry date for the volumetric solutions.
SCOPE :
The procedure is applicable to all the Volumetric Solutions being prepared and
used
for analytical purpose in the Quality Control laboratory,
III.
RESPONSIBILITY :
It is the responsibility of the Quality Control personnel involved in the
preparation,
standardisation / re-standardisation of volumetric solutions to
follow the procedure
IV.
as mentioned in this Standard Operating Procedure.
DOCUMENT REFERENCE :
SOPs :
Core procedure, Documentation Requirements
Coding System Followed in Quality Control Department
STPs :
STPs of all Volumetric Solutions
Forms :
Volumetric Solutions Preparation and Standardisation Records
Volumetric Solution Label
V.
PROCEDURE :
01.
Prepare and Standardise / Re-standardise (as per the schedule) the volumetric
solutions as per the respective Standard Test Procedures and assign lot numbers as
per the Standard Operating Procedure, “Coding System Followed In Quality
Department”.
Control
02.
Enter the raw data including the chemicals used of Preparation and
Standardisation /
Re-standardisation, date of expiry in the respective forms. All the
details should be
in accordance to the core procedure, “Documentation
Requirements”.
03.
Assign the date of expiry and Re-standardisation dates for various volumetric
solutions as follows.
S.No.
Volumetric solution
Expiry period
(From the date
of preparation)
30 days
Re-standardisation
period
01.
1 N Sodium hydroxide
02.
0.1 N Sodium hydroxide
30 days
1 week
03.
1 N Sulphuric acid
30 days
04.
0.1 N Sulphuric acid
7 days
1 week
1 day
05.
0.1 N Iodine
7 days
1 day
06.
0.1 N Sodium thiosulphate
7 days
1 day
07.
0.1 N Perchloric acid
7 days
1 day
Re-standardisation
period
1 week
08.
0.1 N Ammonium thiocyanate
Expiry period
(From the date
of preparation)
1 month
09.
0.1 N Potassium permanganate
1 month
1 week
10.
0.1 M EDTA
1 month
Every 10 days
11.
0.05 M EDTA
1 month
Every 10 days
12.
0.05 M Magnesium sulphate
1 month
1 week
04.
Do not use the solution after expiry date, discard it.
05.
Re-standardisation activity should take place before the first use of the solution on
S.No.
Volumetric solution
1 week
that day.
06.
Re-standardise the Karl Fischer reagent once in the starting of each shift.
07.
Attach volumetric solution label to the solution bottle the solution name,
normality /
molarity lot No., date of preparation, prepared by, standardized on,
restandardised on, restandardised by etc.. and the details shall be checked by a
second person.
08.
The details of the re-standardisation shall be entered in the re-standardisation
details
label subsequent to their recording in the corresponding forms. The
details shall be
09.
checked by a second person.
For the potentiometric titrations standardise the solution on the day of analysis
and discard the solution after the usage on the same day.