- It t part of analytical method validation
Definition:
Specificity to defined capability to assess unequivocally the analyte in the presence of components which may be expected to be present. They might be impurities, degradants, matrix, etc.
Here we identify that
Any interference found in sample
Like you made tablet azithromycine in such a case observer
CASE ASSAY by HPLC
Any interference like
Placebo
Blank
Degradent
Solvents
Dilution etc
CASE ASSAY by HPLC
Any interference like
Placebo
Solvents
Dilution
Texture of other impurity
( not affected retention time)
Same case to apply in dissolution test
If not any interference
( Not affected Main peak RT ) found that say method is specify And go next parameters
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- Laboratory Incident Report
- Incident, Deviation,OOS,OOT describes
- Detailed Regulatory Nuances
- OOS AS PER FDA
- Description of Incident
The High-Performance Liquid Chromatography (HPLC) sequence was interrupted unexpectedly during a scheduled run.
Analysis in Progress: - Specificity analytical method validation creative way to understand
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