Standard Operating Procedure for preparation & standardization of volumetric solution

1. OBJECTIVE:

To lay down a procedure for preparation & standardization of volumetric solution.

• SCOPE:

This procedure is applicable for procedure for preparation & standardization of volumetric solution.

• RESPONSIBILITY:

QC Officer/ QC Executive

• ACCOUNTABILITY:

QC Manager.

•  PROCEDURE:
  • General Instructions:
    • All chemicals / solvents used for preparation of volumetric solutions and reagents shall be LR Grade / AR Grade.
    • All volumetric solutions / reagent shall be prepared in purified water or distilled water.
    • Prepared the Volumetric Solution  and determine the normality of volumetric solution.
  • Preparation & Standardization of Volumetric Solutions:
    • All volumetric solutions/reagents shall be freshly prepared weekly, once in 15 days, once in every month/ three months or whenever the solution shows any fungal growth or sedimentation and deviation of the strength [Molarity /Normality] from the desired value not more than ± 10%.
    • Preparation of volumetric solution is documented.
    • Re-standardize the Volumetric solutions as per the following frequency or before use whichever is later.
    • Records will be maintained in the Volumetric Solution Standardization Record.
    • Standardization shall be determined in triplicate either by manually or potentiometrically (wherever applicable). Strength of volumetric solution shall be within ± 10.0 % of the specified strength. Record shall be maintained.
    • Code sequence of volumetric solution QC/VS/000-00.
      • Where QC is Quality Control.
      • Where VS is Volumetric Solution
      • Where 000 is ID No. Volumetric Solution.
      • Where 00 is mention for no. of determination of normality of Volumetric Solution.
    • Store all volumetric solutions / reagents in borosilicate stopper glass bottle, protected from heat, air & moisture. Volumetric solutions / reagents shall be stored in amber/transparent stopper glass bottles.
    • Standardization of volumetric solution should be standardize ± 1 days from due date of standardization.
    • Label the volumetric solutions status label.
    • After use the volumetric solution should be mention volume of volumetric solution.
    • Record maintain of primary standard during use of primary standard; determine the normality of volumetric solution.
    • Affix the label on primary standard.
    • Prepared the list of primary standard.
• TRAINING:

Trainer   : Manager – Quality Control

Trainees : Staff of the QC departments

• DISTRIBUTION:

Master Copy                  :           QA Department

Controlled Copy            :           QC Department

Display Copy                 :           QC Department

• REFERENCES:

In-House