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FOR EXPERT REVIEW PANEL USE ONLY
NOT FOR DISTRIBUTION
(DRM)
1
Expert Review Panel for Infant Formula and Adult Nutrition
“Designate a Recommended Dispute Resolution Method (DRM)”
Evaluation of Method 2016.02
Title:
Determination of Biotin by Liquid Chromatography Coupled with Immunoaffinity
Column Clean-Up Extraction
Author:
George Joseph
Did Method Author Consider ERP’s General Recommendations:
•
Was the method tested using all the SPIFAN samples for precision and accuracy?
All fortified SPIFAN matrices were included in the MLT.
•
Was data provided from a standard reference material?
Yes. SRM 1849a MLT mean: 196.5 mcg/100g, NIST Certified Value 1990 ±130 mcg/kg.
•
Was the analysis conducted using ready-to-feed (reconstituted) infant formula?
Yes.
•
Was rice based formula available and was it used?
No. SPIFAN kit did not include rice based formula.
•
Was the method tested using properly characterized standards?
Method specifies Sigma biotin and biocytin standards of at least 99% purity. Method
does not include any purity checks of the standard, but Sigma provides a certificate
of analysis.
•
Is there proof of performance through system suitability?
Yes. 6 precision injections at beginning of sequence, full sets of standards injected at
start and end of sequence, 6 point calibration correlation of not less than 0.997, and
injection of on calibration standard after every 5 sample injections, but method does
not list acceptance criteria for most suitability tests.
•
Is there clarity of calibration procedure?
Yes
•
Was the SPIFAN SLV guidelines followed?
NAP
•
Does the method demonstrate repeatability? To what extent?