SOP FOR PREPARATION, STANDARDIZATION AND USE OF VOLUMETRIC SOLUTIONS

SOP FOR PREPARATION, STANDARDIZATION AND USE OF VOLUMETRIC SOLUTIONS

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1.0 OBJECTIVE:

To lay down a standard procedure for preparation, standardization and use of volumetric solutions as per Pharmacopoeial standards and in house standards in Quality Control Department.

2.0 SCOPE:

This SOP is applicable for preparation, standardization and use of volumetric solutions used in Quality Control Department at

3.0 RESPONSIBILITY:

Officers / Executive – Quality Control shall be responsible for complies of this SOP

4.0 ACCOUNTABILITY:

   Manager- Quality Control and Head QA shall be accountable for compliance of this SOP.

5.0 ATTACHMENTS:

         Format for label of Volumetric solutions bottle                                         Attachment-I

Format for list of code number for volumetric solutions                           Attachment-II

Format for standardization of volumetric solutions                                   Attachment-III

Format for Restandardization of volumetric solutions                               Attachment-IV

6.0 PROCEDURE:

    • PREPARATION AND STORAGE:
  •  Use clean and dry bottle for storage of volumetric solution. Store the photosensitive solutions in amber colored bottles.
  •  Prepare the volumetric solutions and standardization as per procedure mentioned in GTP or IP/BP/USP.
  •  All the reagents used for preparation of volumetric solution should be of AR / GR / Spectroscopy grade only.
  • Label the bottle with Name, ID No., Molarity /Normality, reference, prepared by/Date, Checked by/Date, use before, standardization by/Date,  Restandardization date.
  • Code number of volumetric solution shall be VS-0000 Attachment-II.
  • Use the prepared solution within one month.
  • While taking the solution for use, ensure that there is no precipitation or haziness.
  •  If any precipitate or haziness is observed discard the solution and clean the bottle and prepare fresh solution as per step No. 5.1.1 to 5.1.6.
  •  To avoid the contamination do not dip pipettes in the bottle and do not pour the remaining volumetric solution in the bottle.

6.2 STANDARDIZATION:

    • Volumetric solution are standardized after preparation as per the frequency specified in respective GTP’s or as and when required.
    • Use the primary standards for the standardization of the volumetric solutions. All the primary standards should be of AR/GR/Spectroscopy grade only.
    • Standardize the solution as per the respective GTP’s or IP/BP/USP/EP. Dry the standard before use as given in the Pharmacopoeia or GTP.
    • Standardize the volumetric solutions in Triplicate and calculate mean.
    • Record the observations of the standardization in the standardization data sheet of respective volumetric solution and calculate the Normality / Molarity as per requirement.
    • The calculated morality / normality shall not differ from the prescribed strength by more than ± 5% and the morality / normality shall be determine with a precision of 0.2%.
    • Restandardization shall be done after 15days from the date of preparation.
    • Record the observations of the restandardization in the restandardization data sheet of respective volumetric solution and calculate the normality / molarity as per requirement.
    • As soon as the shelf life of the solution is over, it shall be discarded under the running water and the record of destruction shall be specified in remarks column of preparation and standardization log book.
  • REFERENCES:

In-house

  • ABBREVIATIONS

         SOP: Standard Operating Procedure.

QC: Quality Control.

GTP: General Test Procedure.

AR: Analytical Reagent

GR: General Reagent

FT: Format

IP: Indian Pharmacopoeia

BP: British Pharmacopoeia

EP: European Pharmacopoeia

USP: United state Pharmacopoeia

  • DISTRIBUTION LIST

   Quality Assurance Department

Quality Control Department

10.0  HISTORY OF REVISION

Version  No. Date of Revision Reason for Revision
00 New SOP
   
Title : Standardization record  of volumetric solutions

 
Version No.
:
00
Page No.
 :

 Page 1 of 1

 
Effective Date
:
Review Date
 :  

 

Attachment -III

 

Sr. No. Prep. date Exp.

date

 Standardization

Date

 Normality I Normality II Normality III Actual Strength Prepared By Checked By

 
 

 

 

  

 

  

 

 
 

 

 

  

 
   
Title : Re-standardization of volumetric solutions

 
Version No.
:
00
Page No.
 :

 Page 1 of 1

 
Effective Date
:
Review Date
 :  

 

Attachment -IV

 

Sr.No. Prep. date Exp.

date

 Re-Standardization

Date

 Normality I Normality II Normality III Actual Strength Prepared By Checked By

 
 

 

 

  

 

  

 

 
 

 

 

  

 

NAME OF VOLUMETRIC SOLUTION:-                                                     

Attachment -IV

 

Sr.No. Prep. date Exp.

date

 Re-Standardization

Date

 Normality I Normality II Normality III Actual Strength Prepared By Checked By

 
 

 

 

  

 

  

 

 
 

 

 

  

 

                                     

 

 

 

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