What is update change

Definitions

• Here Definitions and chromatograms both unified and give title Definitions
• Give method dwell volume determine being added
• Definitions add definitions size-exclusion chromatography  (Distribution constant, Retention time of an unretained compound, Total mobile phase time)
• Also other definitions plate height, reduced plate height, plate number etc

In TLC –

• resolution calculation base on the peak widhs at the base line is remove .
• Resolution definition and formula to calculate resolution added.

Signal to noise

• Signal to noise ratio move form system suitability section to definition section
• Noise range are change in calculation being modified form 5 to 20 peak width

System Suitability

• System sensitivity and peak symmetry (tailing Factor) (0.8 – 1.8)  is added

Base on chromatographic system

• Allowed adjustments for TLC are being added (Composition of mobile phase, pH, Concentration of salts in buffers, Application volume)
• A formula to calculate changes in Injection volume is included
• A new section is added to include all the allowed adjustments in Gradient elution: Particle size adjustment in gradient (see Column dimensions) and Injection volume are being added
• Gas Chromatography adjustments are listed in a separate sub section

Quantitation

• The example regarding the use of correction factors when RRF are outside  of the 0.8 – 1.2 range have been removed
• The term Disregard limit is being replaced by Reporting thresholds