To provide a methodology for the preparation, standardisation / re-standardisationand to provide expiry date for the volumetric solutions.
I. PURPOSE :
To provide a methodology for the preparation, standardisation / re-standardisationand to provide expiry date for the volumetric solutions.
II. 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 as mentioned in this Standard Operating Procedure.
IV. DOCUMENT REFERENCE :
SOPs : Core procedure, Documentation RequirementsCoding System Followed in QualityControl Department
STPs : STPs of all Volumetric Solutions
Forms : Volumetric Solutions Preparation and Standardisation RecordsVolumetric 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 Control Department”.
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) Re-standardisation period
01. 1 N Sodium hydroxide 30 days 1 week
02. 0.1 N Sodium hydroxide 30 days 1 week
03. 1 N Sulphuric acid 30 days 1 week
04. 0.1 N Sulphuric acid 7 days 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
S.No. Volumetric solution Expiry period
(From the date of preparation) Re-standardisation period
08. 0.1 N Ammonium thiocyanate 1 month 1 week
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 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 checked by a second person.
09. For the potentiometric titrations standardise the solution on the day of analysis and discard the solution after the usage on the same day.
Preparation, standardisation, re-standardisation, volumetric
