Friday, November 26, 2010

Preparation, standardization and shelf life of volumetric solutions, standard reagent solution and indicators.

1.0       Purpose    :  To provide instructions for the Preparation, Standardization and Shelf-life of Volumetric solutions, Standard reagent solution and Indicators.

2.0     Objective      :    To provide documented procedures for Preparation, Standardization and Shelf life of Volumetric solutions, Standard reagent solution and Indicators


3.0     Scope       :  This procedure is applicable for preparation, standardization and shelf life of                     volumetric solutions, standard reagent solution and indicators in QC Department of ------ Pharmaceutical. Ltd, Ankleshwar.

4.0      Responsibility  :
§         Primary     : QC Chemist
§         Secondary : Overall: QC Officer
  
5.0      Procedure      :
·   Volumetric Solutions
Ø      Volumetric solution shall be prepared as mentioned in the respective procedure.
Ø      Volumetric solutions shall be prepared by accurately weighing a specified quantity & dissolving it to produce a specific volume.
Ø      Records shall be maintained in respective logbook.
Ø      Volumetric solutions shall be standardized by titration against a primary standard or by titration with a standard solution that has been recently standardized against a primary standard.
Ø      Record shall be maintained.
Ø      Volumetric solutions shall be standardized before use; shelf life of this solution is one month from the date of preparation. Discard the solution after one month or if observed hazy.
Note: Strength of the volumetric solutions should not deviate more than 10% of the prescribed strength.
Ø      All volumetric solutions should be standardized in triplicate set & % RSD should not be more than 0.20 %. Average value shall be reported.
Ø      All the bottles should be labeled indicating the name, strength of the solution, date of preparation, signature of the person who prepared it, use before date, standardization due on, date of standardization.
Ø      Records shall be maintained for each solution starting with the value determined when the solution was prepared & continuing with the values determined throughout the shelf life of the solutions in respective register.
Ø      This record shall be retained for at least 1 year after the solution has expired.
Ø      Solutions of limited stability should be prepared on the day of use & discarded on completion of analysis.
·        Standard Reagent Solutions:
Ø      Standard Reagent solutions shall be prepared as mentioned in the respective procedure.
Ø      Standard Reagent solutions shall be prepared by accurately weighing a specified quantity & dissolving to produce a specific volume.
Ø      Records shall be maintained in respective register.
Ø      All the bottles should be labeled indicating the name, strength of the standard reagent solution, date of preparation, signature of the person who prepared it, use before date.
Ø      Shelf life of these standard reagent solutions is Three months from the date of preparation. Discard the solution after three months or if observed hazy.
Ø      This record shall be retained for at least 1 year after the solution has expired.
·        Indicators:
Ø      Use readymade indicators of MERCK make.

6.0      Reference Document:



v     Volumetric solution preparation and standardization logbook



 

         LOG BOOK FOR VOLUMETRIC SOLUTIONS STANDARDIZATION




Name of volumetric solution: ___­­­­­­­­­­­­­­­­­­­­_____________ Name of primary std.: ____________


Date of preparation
Date of standardization
Wt. of primary std. + pager        

Wt. of paper

 

Wt. of primary std.

B.R.
 in ml
Molarity/Normality =

   Wt. of primary std. X 1000

B.R. X Mol. weight
Mean
Normality
Standardized by
Discarded on























Format No. F/QC/002



v     Standard reagent solution preparation logbook
LOG BOOK FOR REAGENT SOLUTIONS


Name of volumetric solution: ___­­­­­­­­­­­­­­­­­­­­___________________        Name of primary std.: __________






Date of    preparation
Wt. of primary std. + pager         in g
Wt. of paper    in g
Wt. of primary std.  in g
Volume of standard solution
Dilution solvent
Final volume
Strength
Prepared by
Discarded on




















Format No. F/QC/003


No comments:

Post a Comment

Related Posts Plugin for WordPress, Blogger...
Subscribe to Quality Assurance and GMP by Email