|STANDARD OPERATING PROCEDURE|
|Title||:||Procedure for Preparation, Standardization and Re-Standardization of Volumetric solutions
- This SOP describes the procedure for Preparation, Standardization and Re-Standardization of Volumetric solutions.
- This procedure is applicable for preparation and standardization of volumetric solutions in Quality Control.
- Officer / Executive-QC – responsible for Implementation of SOP.
- Manager Quality Control
- Wear surgical gloves during preparation of volumetric solutions.
- Take appropriate glassware of suitable capacity to prepare the volumetric solutions.
- Use AR & LR Grade chemicals for the preparation of Volumetric Solutions.
- Ensure that chemical is within ‘use before date’ from the sticker on the container.
- Store all the solutions in cleaned dry glass bottles. Store light sensitive solutions in amber color glass bottle.
- Prepare volumetric solutions as per IP/BP/USP/EP or respective In-House standard test procedure for that specified volumetric solution.
- Prepare the volumetric solutions after every 90 days or if physical appearance changes.
- Fill the label of the volumetric solution with following details and affix it on the container.
- Standardize the volumetric solution after the preparation and re-standardize as per given schedule of relevant volumetric solution.
- Documentation maintain in “Raw Data Record of Volumetric Solution.
- Paste a label on the side of reagent bottle with Name, Molarity, Date of Preparation, Date of Standardization, Date of Re-standardization, and Use before date, Prepared By and Checked
- Standardize the volumetric solution in triplicate.
- The RSD of three analyses should be not more than 0.2%.
- Use average of 3 values for calculation.
- Before signing the records, In-charge QC checks all calculations for correctness and ensures that solutions are prepared as per standard procedure.
- Re-Standardization every 15 days as per the format.
SOP – Standard operating procedure
QC – Quality Control
- DISTRIBUTION LIST
|Sr. No.||Copy No.||Department|
|VP – Plant & Operations|