Incidences are any unintentional/ unexpected event that occurs during analysis, discovered during analysis, and after analysis that may adversely affect the data quality and the result. Lets quickly go some of the common incidences which are observed during method validation activity.
Instrument related:
- Power Failure
- Sudden drift
- Communication failure
- Hardware error- solvent homing faut, injector breakdown
- Lamp Intensity Failure
- Leakage
- High pressure-choke of frit
- Use out-of-calibrated instruments
Analyst related:
- Incorrect Standard Preparation
- Incorrect Sample Weighing
- Mobile Phase Preparation Error or Improper Mixing of Mobile Phase
- Incorrect pH Adjustment
- Wrong Diluent Used and Wrong Diluent Volume
- Inadequate or improper integration
- Wrong vial numbering in the sequence
- Wrong Injection Volume
- Wrong Detector Wavelength
- Improper HPLC/ GC handling
- Inadequate or improper documentation
- Not trained to handle or perform analysis
Chromatography related:
- Poor Plate Count, tailing
- Improper separation (merging the components)
- Failure of % RSD of standard bracketing standard
- Spikes or ghost peaks
- Variation the peak response, baseline
- Extraneous peak apart from blank, diluent etc.
- Carryover
Sample related:
- Sample degradation over time, leading to inaccurate results
- Poor storage leading to changes in the physical form
- Improper sample preparation/extraction procedure eg. insufficient sonication time, stirring etc.
- Accidental spillage or glassware breakage
- Contamination of sample during preparation
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Resource Person: Jairus Fernandes