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Parameter
Method Performance
Please
report in units as stated in SMPR!
Weighting
factor for
parameter
Suitability Ranking (1‐
3‐5)
(select from drop‐down
list, 5 = best)
SPIFAN matrices
Applicable to all forms of infant, adult, and/or pediatric
formula (powders, ready‐to‐feed liquids, and liquid
concentrates).
Any combination of milk, soy, rice, whey, hydrolyzed
protein, starch, and amino acids, with and without intact
protein.
Applicable to all forms of infant, adult and/or
pediatric formula (powders, ready‐to‐feed liquids,
and liquid concentrates. Any combination of milk,
soy, rice, whey, hydrolyzed protein, starch, and
amino acids, with and without intact protein.
1
All analytes defined in the
applicability statement are
measured.
Total Niacin based on analysis of nicotinic acid and
nicotinamide
Total Niacin based on analysis of nicotinic acid
and nicotinamide
1
200‐10000
195‐10000 (2.3 x dilution of the extract >4000
mcg/100g)
Analyte 1
Total Niacin
60 mcg/100g (RTF or Reconstituted)
Analyte 2
Analyte 3
Analyte 4
Analyte 5
Analyte 1
Total Niacin (< 200 mcg/100g)
195 mcg/100g (RTF or Reconstituted)
Analyte 2
Analyte 3
Analyte 4
Analyte 5
Spike recovery (%)
90‐110%
99.50%
2
Bias vs SRM
NIST SRM 1849 a Expected = 108.13 + 9.92 mg/kg as
niacinamide
104.5 + 5.0 mg/kg, (% of NIST SRM Value = 96.7),
n=7 , as niacinamide
3
<5%
0.6‐4.9% (21 values)
(3 exceptions = 6.4%, 7.2% and 7.6%)
<5%
3.5‐6.0%
(all samples analyzed in triplicates on two days,
total n=6)
b
Units
Bias against established method
Analytical equipment
1
Adequate proof of performance via system suitability
Is there a bias Yes/No ?
Analytical equipment is commonly available in most labs.
move to Final Action/repeal/remove/expand 2 year term
0
No unique proprietary equipment/accessories are required.
Method does not require any special safety precautions e.g. personal protection from highly toxic solvents.
3
1
2
AOAC SMPR: ………….. 2015.004
Limit of detection (LOD)
1
a
Concentrations apply to (1) "ready to feed liquids" "as‐is"; (2) reconstituted powders (25 g into 200 g water); and (3) liquid concentrates diluted 1:1 by weight.
Did Method Author Consider ERP’s Method Specific
Recommendations
(See web link to specific method
comments):
Decision by ERP
Proprietary equipment
Notes:
Overall Score
Recommendation of ERP
2 years after First Action Status
Laboratory safety
Other Considerations
Evaluation of Method Performance vs. SMPR requirements.
Feedback from Users of the Method since being awarded
First Action
Official Methods
Status
Repeatability (RSDr)
Reproducibility (RSDR)
Accuracy/Recovery
ADDITIONAL EVALUATION PARAMETERS
Intermediate Reproducibility
(RSDiR)
Limit of quantification (LOQ)
Method Reference #
Analytical Range.
1
Method title:
Principle of the method:
A LC‐MS/MS Method for Analysis of Total Niacin (vitamin B3) based on Nicotinic Acid and
Free as well as bound nicotinic acid and nicotinamide are extracted employing protease and taka‐diastase
treatments The sample extracts are analyzed using liquid chromatography (LC) with tandem mass
SMPR Requirement
SPIFAN ERP Checklist v 1.6
27.06.2013
BVIT-04 MEF FORM (AUGUST 2016)
FOR ERP USE ONLY
DO NOT DISTRIBUTE