To lay down a procedure for stability study of volumetric solution & indicators.
This procedure is applicable for procedure for stability study of volumetric solution.
QC Officer/ QC Executive
- 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, 2nd week, 3rd week, 4th week, 5th week, 6th week, 7th week, 8th week, 9th week, 10th week & 11th 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 shelf life of volumetric solution.
Trainer : Manager – Quality Control
Trainees : Staff of the QC departments
Master Copy : QA Department
Controlled Copy : QC Department
Display Copy : QC Department