170135_inorganicventures_flipping

17.6 Method Validation

Confirm Basic Performance Criteria : Specificity

• Specificity involves the process of line selec2on and confirma2on that interferences (of the types discussed in part 15 and part 16) for the ICP-OES or ICP-MS measurement process are not significant. • A comparison of results obtained using a straight calibra2on curve (without internal standardiza2on to that of internal standardiza2on and/or to the technique of standard addi2ons) will give informa2on concerning matrix effects, driN, stability, and the factors that influence the stability. • The various types of spectral interferences encountered using ICP- MS and ICP-OES should be explored.

17.7 Method Validation

Confirm Basic Performance Criteria : Accuracy or Bias

• Accuracy or Bias can be best established through the analysis of a cer5fied reference material (CRM, or SRM if obtained from NIST). • If a CRM is not available, then a comparison to data obtained by an independent validated method is the next best approach. • If an alternate method is not available, then an inter-laboratory comparison, whereby the laboratories involved are accredited (ISO 17025 with the analysis on the scope of accredita5on) is a third choice. • The last resort is an aNempt to establish accuracy through spike recovery experiments and/or the use of standard addi5ons