© 2015 AOAC INTERNATIONAL
AOAC SMPR 2015.004
Standard Method Performance Requirements
SM
(SMPRs) for Total Vitamin B
3
(Niacin) in Infant and
Adult/ Pediatric Nutritional Formula
Intended Use: Reference Method for Dispute Resolution
1 Applicability
Determinations of total vitamin B
3
(niacin) in all forms of infant,
adult, and/or pediatric formula (powders, ready-to-feed liquids, and
liquid concentrates). Total B
3
GH¿QHG DV WKH VXP RI QLFRWLQLF DFLG
(CAS No. 59-67-6) and nicotinamide (CAS No. 99586-65-9), and
reported as niacin.
2 Analytical Technique
$Q\ DQDO\WLFDO WHFKQLTXH WKDW PHHWV WKH IROORZLQJ PHWKRG
performance requirements is acceptable.
'H¿QLWLRQV
$FFXUDF\ FRUUHVSRQGV WR WKH 9,0 GH¿QLWLRQ IRU ³WUXHQHVV´
.—
7KH FORVHQHVV RI DJUHHPHQW EHWZHHQ WKH DYHUDJH RI DQ LQ¿QLWH
number of replicate measured quantity values and a reference
quantity value.
$GXOW SHGLDWULF IRUPXOD
.—Nutritionally complete, specially
IRUPXODWHG IRRG FRQVXPHG LQ OLTXLG IRUP ZKLFK PD\ FRQVWLWXWH
WKH VROH VRXUFH RI QRXULVKPHQW PDGH IURP DQ\ FRPELQDWLRQ RI
PLON VR\ ULFH ZKH\ K\GURO\]HG SURWHLQ VWDUFK DQG DPLQR DFLGV
ZLWK DQG ZLWKRXW LQWDFW SURWHLQ
,QIDQW IRUPXOD
.—Breast-milk substitute specially manufactured
WR VDWLVI\ E\ LWVHOI WKH QXWULWLRQDO UHTXLUHPHQWV RI LQIDQWV GXULQJ
WKH ¿UVW PRQWKV RI OLIH XS WR WKH LQWURGXFWLRQ RI DSSURSULDWH
FRPSOHPHQWDU\ IHHGLQJ &RGH[ 6WDQGDUG
PDGH IURP DQ\
FRPELQDWLRQ RI PLON VR\ ULFH ZKH\ K\GURO\]HG SURWHLQ VWDUFK
DQG DPLQR DFLGV ZLWK DQG ZLWKRXW LQWDFW SURWHLQ
/LPLW RI GHWHFWLRQ /2'
²7KH PLQLPXP FRQFHQWUDWLRQ RU PDVV
RI DQDO\WH WKDW FDQ EH GHWHFWHG LQ D JLYHQ PDWUL[ ZLWK QR JUHDWHU
WKDQ IDOVH SRVLWLYH ULVN DQG IDOVH QHJDWLYH ULVN
/LPLW RI TXDQWLWDWLRQ /24
²7KH PLQLPXP FRQFHQWUDWLRQ
RU PDVV RI DQDO\WH LQ D JLYHQ PDWUL[ WKDW FDQ EH UHSRUWHG DV D
quantitative result.
5HSHDWDELOLW\
²9DULDWLRQ DULVLQJ ZKHQ DOO HIIRUWV DUH PDGH
WR NHHS FRQGLWLRQV FRQVWDQW E\ XVLQJ WKH VDPH LQVWUXPHQW DQG
RSHUDWRU DQG UHSHDWLQJ GXULQJ D VKRUW WLPH SHULRG ([SUHVVHG DV WKH
repeatability standard deviation (SD
r
RU UHSHDWDELOLW\ UHODWLYH
VWDQGDUG GHYLDWLRQ 56'
r
).
5HSURGXFLELOLW\
²7KH VWDQGDUG GHYLDWLRQ RU UHODWLYH VWDQGDUG
GHYLDWLRQ FDOFXODWHG IURP DPRQJ ODERUDWRU\ GDWD ([SUHVVHG
DV WKH UHSURGXFLELOLW\ UHODWLYH VWDQGDUG GHYLDWLRQ 6'
5
RU
UHSURGXFLELOLW\ UHODWLYH VWDQGDUG GHYLDWLRQ 56'
5
).
VLWDPLQ B
3
(QLDFLQ
²5HIHUV WR WZR FRPSRXQGV QLFRWLQLF DFLG
DQG QLFRWLQDPLGH %RWK IRUPV RI WKH YLWDPLQ DUH HTXDOO\ ELRORJLFDO
DFWLYH 1LFRWLQLF DFLG LV FKHPLFDOO\ S\ULGLQH FDUER[\OLF DFLG
&$6 1R
1LFRWLQDPLGH LV S\ULGLQH FDUER[F\OLF DFLG
amide, CAS No. 99586-65-9.
4 Method Performance Requirements
See
7DEOH
5 System Suitability Tests and/or Analytical Quality Control
6XLWDEOH PHWKRGV ZLOO LQFOXGH EODQN FKHFN VDPSOHV DQG FKHFN
VWDQGDUGV DW WKH ORZHVW SRLQW DQG PLGUDQJH SRLQW RI WKH DQDO\WLFDO
UDQJH
6 Reference Material(s)
1,67 6WDQGDUG 5HIHUHQFH 0DWHULDO
®
650 D ,QIDQW $GXOW
1XWULWLRQDO )RUPXOD RU HTXLYDOHQW 7KH 650 LV D PLON EDVHG K\EULG
infant/adult nutritional powder prepared by a manufacturer of
LQIDQW IRUPXOD DQG DGXOW QXWULWLRQDO SURGXFWV $ XQLW RI 650
FRQVLVWV RI
SDFNHWV HDFK FRQWDLQLQJ DSSUR[LPDWHO\ J RI
PDWHULDO &HUWL¿HG YDOXH RI 1,67 D LV
PJ NJ QLDFLQ
7 Validation Guidance
5HFRPPHQGHG OHYHO RI YDOLGDWLRQ
2I¿FLDO 0HWKRGV RI
$QDO\VLV
SM
.
8 Maximum Time-to-Result
1R PD[LPXP WLPH
Approved by AOAC Stakeholder Panel on Infant Formula and
Adult Nutritionals (SPIFAN). Final Version Date: April 17, 2015.
Effective Date: April 17, 2015.
Table 1. Method performance requirements
a
Analytical range
200–10000
b
Limit of quantitation (LOQ)
b
Recovery
90–110%
Repeatability (RSD
r
)
Reproducibility (RSD
R
)
a
Concentrations apply to: (a) “ready-to-feed” liquids “as is”; (b)
reconstituted powders (25 g into 200 g water); and (c) liquid concentrates
diluted 1:1 by weight.
b
ȝJ J UHFRQVWLWXWHG ¿QDO SURGXFW