Preparation, Standardisation and Storage of Laboratory Solutions – SOP

By / Quality control, SOP / QC, SOP /

Preparation of Laboratory Solutions | Preparation and and Standardization of Volumetric Solution |

  • SOP covers below points:
  • Laboratory Solutions category:
    • Reagents
    • Indicators
    • Volumetric Solution
  • Preparation of Laboratory Solutions
  • Standardisation of Volumetric Solutions
  • Storage of Laboratory Solutions
  • Laboratory Solutions format
1.0 OBJECTIVE :
  • This SOP describes the procedure for Preparation, Standardisation And Storage of Reagents, Indicators and Volumetric Solutions.
2.0 SCOPE :
  • This procedure is applicable for preparation, standardisation and storage of Reagents, Indicators and Volumetric Solutions used in Quality Control laboratory.
3.0 RESPONSIBILITY :
  • Quality Control Chemist and above
4.0 ACCOUNTABILITY:
  • Quality Control Head
5.0 PROCEDURE :

5.1 Solutions used in Quality Control Department is categorised in following three categories:

  • REAGENTS
    • A Reagent is a substance or compound added to a system to cause a chemical reaction, or added to see if a reaction occurs.
  • INDICATORS
    • An indicator is defined as a substance that undergoes distinct observable change when the conditions of its solution change.
  • VOLUMETRIC SOLUTIONS
    • Volumetric solution are used in titrimetric analysis and require the standardisation.

5.2 Preparation:

  • Prepare the required quantity of Reagents, Indicator and Volumetric solutions as per Standard Test Procedure.
    • Prepare Standard Test Procedure for Reagent/ Indicator as per pharmacopoeial reference,  Annexure No.: 05.
    • Prepare Standard Test Procedure for Volumetric Solution as per pharmacopoeial reference, Annexure No.: 06.
    • Standard Test Procedure is prepared by QC officer and checked by QC Executive/ Head.
    • Stick the format in left page, from where the all the relevant details for respective solution are recorded.
  • Use A.R grade chemical for preparation of laboratory solutions.
  • Record the details in “Register for Reagents and Indicators” as per mentioned in Annexure No.: 03.
  • Record all the relevant details in “Register for Volumetric solutions” as per mentioned in Annexure No.: 04.
  • The entries have to be counter-signed by a second person (officer/chemist) after verifying the correctness of the preparation and/or standardization.
  • Prepare List of Reagents/ Indicators/ volumetric solutions as per Annexure No.: 07 and display the list on rack.
  • Give the preparation number to working standard as follows,
    • Preparation Number:  X/YY
      • Where,  X = Laboratory solution, i.e.,  R for Reagent;
      • I for Indicator ;
      • VS for volumetric solution.
      • YY = Serial number (from list) starting from 01. 

5.3 Standardisation of Volumetric Solutions :

  • Prepared volumetric solutions required standardisation. Carry out Standardisation as per the Standard Test Procedure.
  • Record all the details of standardisation such as date, weights, and titration readings etc. and signature of the chemist performing the standardisation in the volumetric solution.
  • Carry out all standardisation in duplicate and the mean of the two values recorded as the Molarity / Normality in volumetric register.
  • The duplicate values must not differ by more than 0.2% RSD.
  • If the values differ by more than 0.2%, the standardisation is repeated once again in triplicate, where the variations between results must not be more than 0.2% RSD.
  • This mean value is to be entered on the label of the bottle along with the date and initials of the chemist.
  • Standardise all volumetric solutions within two days from the date of preparation.
  • Acceptance Criteria:
    • The strength (molarity) of the volumetric solution prepared do not differ from the prescribed strength by more than 5%.

5.4  Storage :

  • Stored the laboratory solution in suitably hard borosilicate glass bottles with stopper (amber colored for light sensitive solution) and labeled accordingly.
  • Use bottles of 500 ml capacity for all the volumetric solutions.
  • Use  bottles of 250 ml capacity for all the Reagents and Indicators.
  • Assign Shelf life (valid up to) as below,
    • All reagents/Indicators are to be used within three months of their preparation and discarded thereafter.
    • A shorter shelf life should be employed wherever the monograph specifically says so or whenever any deterioration/ discolouration/ loss of property are observed in any reagent/solution.
    • Volumetric solution are to be prepared for one months and discarded thereafter.
    • In case of addition of new volumetric solution, ascertain shelf life as per SOP of Shelf life of volumetric solution.
  • Keep all bottles in a rack according to preparation number.
  • Arrange the all solutions in such a way that the label on the bottles is easily Readable.
  • Closed the lid/stopper of the bottle after use to avoid contamination.
 6.0 ABBREVIATIONS:
AbbreviationExpanded form
%Percentage
MMolar
QCQuality Control
RSDRelative Standard Deviation
mlMilliliter

7.0 ANNEXURES:
Annex. No.                      Title
01Label for Reagent / indicator
02Label for Volumetric Solution
03Register for Reagents / indicators  
04Register for Volumetric Solutions
05Standard Test Procedure  for Reagent/Indicator
06Standard Test Procedure  for Volumetric Solution
07List of  Reagents / indicators  / Volumetric Solution

8.0 SOP REFERENCES
  • GLP Guideline

END OF THE SOP

ANNEXURES :

Annex. No. 01 Label for Reagent / indicator

Annex. No. 02 Label for Volumetric Solution

Annex. No. 03 Register for Reagents / indicators

Annex. No. 04 Register for Volumetric Solutions

Annex. No. 05 Standard Test Procedure for Reagent/Indicator

Annex. No. 06 Standard Test Procedure for Volumetric Solution

Annex. No. 07 List of Reagents / indicators  / Volumetric Solution