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FOR EXPERT REVIEW PANEL USE ONLY
NOT FOR DISTRIBUTION
2
SRM-1849a
99804 ppb
106.6 mg/kg
Method Clarity:
Section D.2.e. (p33 of PDF) does not describe the preparation of the nicotinic acid internal standard
Section D.2.f. (p33 of PDF) does not describe the addition of either niacinamide or nicotinic acid to
the internal standard solution ISSM
Section D.2.g. (p34 of PDF) does not describe the preparation of either niacinamide or nicotinic acid
native standards
Section D.2.h. (p35 of PDF) does not describe the addition of either niacinamide or nicotinic acid
native standards to the intermediate working standard solution IWSS
Method Safety Concerns:
Pros/Strengths:
Measures all forms of all vitamins required by the SMPR.
Cons/Weaknesses
Supporting Data
General Comment:
New comparison data was provided for this ERP for samples in the SPIFAN II set, between the fortification
level (where known), and the values obtained by microbiological assay, BVit-01 (MJ), and BVit-02 (AN). On
average, the BVit-01 (MJ) values were 107% of the BVit-02 (AN) values, and were higher in 12 of 14 cases.
For 11 samples in which the fortification was known, the values produced by BVit-01 (MJ) were 111% and
by BVit-02 (AN) 104% of these fortification values.
–
Method Optimization:
Performance Characteristics:
B
3
SMPR: Total niacin as niacinamide and nicotinic acid
Analytical Range:
B
3
SMPR: 200 – 10000 mcg/100g as fed
The samples tested ranged in concentration from ~1300 - ~7200 ppb as is for nicotinic acid and
29000 – 110000ppb for niacinamide (as is, not as reconstituted)
LOQ:
B
3
SMPR: 200 mcg/100g as fed
LoQ was calculated using the lowest standard concentration and typical sample mass and dilution,
which met the SMPR requirement.
Accuracy/Recovery:
BVit-02 Review Forms