139 / 159
FOR EXPERT REVIEW PANEL USE ONLY
NOT FOR DISTRIBUTION
4
Reproducibility (RSD
R
):
NAP
System suitability:
As noted previously, method suitability requirements are sparse.
Linearity is discussed for both vitamin D2 and D3 with few details in how the curve is generated.
Performance requirements around injection precision, standards stability, curve performance (linearity,
residuals, IS recovery), chromatography (eg. RT, symmetry, peak width, etc) should be added.
Recommendation:
This method is similar to VitD-18 and for same reasons has very strong potential. More detail is need on
the assessment of pre-D, either via direct or indirectly measurement.
An IS for vitamin D2 is recommended.
Further work required.
VitD-17 Review Forms