1.0 OBJECTIVE:To lay down the procedure for preparation and standardization of volumetric solution.
2.0 SCOPE:This SOP shall be applicable to Quality Control Dept.
3.0 RESPONSIBILITY:Supervisor Quality Control
4.0 ACCOUNTABILITY:Sr. Manager Quality Assurance
5.0 PROCEDURE:5.1 Maintain the register for preparation and standardization of volumetric solutions.
5.2 Allocate at least 3 pages for each volumetric solution. Write the name of volumetric solution on the Top of the pages.
5.3 Prepare an index of all the volumetric solutions on the first page of the register.
5.4 Prepare the table for every solution giving details of date of preparation, use before date, date of standardization/ re-standardization, standardized by along with other relevant details.
5.5 Prepare a sufficient volume of each volumetric solution to last for about three months, store it in a glass stoppered bottle, label it properly and keep it in specified rack. Do not store the stock solution on the work bench.
5.6 Before using any volumetric solution, shake the solution well in order to mix the drops of water condensed on the top and sides of the bottles with the solution in the bottle.
5.7 Wherever drying of Primary Standard is required by the procedure for standardization, primary standards shall be dried at specified temperature.
5.8 Carry out the standardization three times. The results should not differ by more than 0.5 %. In case the Standard deviation is more than 0.5 %, repeat the standardization afresh.
5.8 Record the Normality/ Molarity of solution in the record register.
5.9 The volumetric solution should not be used after 3 month from date of preparation. Re-standardize the volumetric solution every fifteen days.
5.10 Volumetric Solution should be labelled properly and label should contain the following details:
a) Name of Reagent / Solution
c) Actual Molarity/Normality
d) Prepared by name
e) Date of preparation
f) To be used before
g) Date of Standardization/Re-standardization
h) Valid until
Related: Determination of Shelf Life of Solutions in Laboratory
6.0 ABBREVIATIONS:6.1 SOP : Standard Operating Procedure
6.2 QA : Quality Assurance
6.3 QC : Quality Control
6.4 Dept. : Department
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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