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

STANDARD OPERATING PROCEDURE
Title: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
Sr. No.Copy No.Department
Quality Assurance
Quality Control
VP – Plant & Operations

 

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