5841 v2
Page 9 of 9
AsureQuality Laboratory Services
6. SUMMARY AND CONCLUSION
AsureQuality Auckland Laboratory has initiated a method to facilitate a specific, precise,
accurate and robust procedure for the analysis of biotin from Infant Formula and Adult /
Pediatric Nutritional Formulas.
The method involves immunoaffinity column (R-Biopharm Rhone, EASI-EXTRACT biotin
column) clean-up and extraction followed by liquid chromatography with UV detection.
The proposed method performance exceeds all the SPIFAN SMPR for biotin. The method
also has an assured limit of quantification of 0.1μg/100g (1ppb) based on a simple
mathematical relationship between lowest standard and the dilution. This method is found to
be suitable for routine testing of biotin in infant formula and adult nutritionals. Comparison of
SMPR for biotin and the proposed method performance are given in Table 5.
Table 5: Performance of the proposed method (Bio -02) compared to SMPR 2014.005
Parameters
SMPR 2014.005
Proposed Method Comments
Analytical Range
0.1 - 150 μg/100g 0.1 - 300 μg/100g
Analytical range of the proposed method is wider
based on the sample weight taken and loading
volume for sample extraction.
Limit of Quantitation
≤0.1 μg/100g
≤0.1 μg/100g
The proposed method meets the LOQ of 0.1
μg/100g as required by AOAC SMPR 2014.005.
Repeatability (RSD
r
)
>1 μg/100g: ≤6%
>1 μg/100g: ≤4%
Repeatability of the proposed method is better
than the SMPR 2014.005.
Recovery
(>1μg/100g)
90 to 110%
95 to 105%
All the spiked recoveries by the proposed method
are better than the recovery range specified by
AOAC SMPR 2014.005.
NIST SRM 1849a
199 ± 13
198 ± 3
NIST 1949a results are at the certified value.
Bio-02 (February 2016)
FOR ERP USE ONLY
DO NOT DISTRIBUTE