Procedure for Preparation, Standardization and Re-Standardization of Volumetric solutions

•     OBJECTIVE
  • This SOP describes the procedure for Preparation, Standardization and Re-Standardization of Volumetric solutions.

• SCOPE
  • This procedure is applicable for preparation and standardization of volumetric solutions in Quality Control.
• RESPONSIBILITY
  • Officer / Executive-QC – responsible for Implementation of SOP.
• ACCOUNTABILITY
  • Manager Quality Control
• PROCEDURE
  • 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.
•      ABBREVIATION

  SOP      –  Standard operating procedure

    QC       –  Quality Control

•     FORMAT
  • Nil

•     DISTRIBUTION LIST