SOP for stability study of volumetric solution & indicators

1. OBJECTIVE:

To lay down a procedure for stability study of volumetric solution & indicators.

• SCOPE:

This procedure is applicable for procedure for stability study of volumetric solution.

• RESPONSIBILITY:

QC Officer/ QC Executive

• ACCOUNTABILITY:

QC Manager.

• PROCEDURE:
  • Preparation, standardization and storage of volumetric solution shall be as per SOP.
  • Initial standardization of volumetric solution shall be done on same day or next day as per general test procedure of pharmacopoeia and maintain a record of preparation and standardization.
  • Standardization shall be done in date of preparation or next day, 2^nd week, 3^rd week, 4^th week, 5^th week, 6^th week, 7^th week, 8^th week, 9^th week, 10^th week & 11^th week.
  • Normality at each interval should not be differing more than 1.0% of the initial normality.
  • If the solution does not meet criteria up to 14 days then shelf life shall be considered 7 days.
  • If the solution does not meet criteria up to 30 days then shelf life shall be considered 15 days.
  • If the solution does not meet criteria up to 42 days then shelf life shall be considered monthly.
  • Report of indicator sensitivity test in format.

• 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

• ABBREVIATIONS:

Abbreviations	Extended Form
SOP	Standard Operating Procedure
NA	Not Applicable
QC	Quality Control
Sr. No.	Serial Number
QA	Quality Assurance
DEPT.	Department

1. REVISION HISTORY OF CHANGE:

Sr. No.	Date	Revision Details	Revision No.
01	31/12/2019	NEW SOP	00