Review Team (February 2016)

AOAC SMPR 2015.003

Table 1. Method performance requirements a Analytical range

30–4000 b

Limit of quantitation (LOQ)

”

b

Standard Method Performance Requirements SM (SMPRs) for Total Vitamin B 2 5LERÀDYLQ LQ ,QIDQW and Adult/ Pediatric Nutritional Formula

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

Intended Use: Reference Method for Dispute Resolution

1 Applicability Determinations of total vitamin B 2 ULERÀDYLQ LQ DOO IRUPV RI infant, adult, and/or pediatric formulas (powders, ready-to-feed OLTXLGV DQG OLTXLG FRQFHQWUDWHV 7RWDO % 2 GH¿QHG DV WKH VXP RI ULERÀDYLQ &$6 ULERÀDYLQ މ SKRVSKDWH &$6 DQG ÀDYLQ DGHQLQH GLQXFOHRWLGH &$6 $OO GDWD VKRXOG EH PDVV FRUUHFWHG DQG H[SUHVVHG DV ULERÀDYLQ 2 Analytical Technique $Q\ DQDO\WLFDO WHFKQLTXH WKDW PHHWV WKH IROORZLQJ PHWKRG SHUIRUPDQFH UHTXLUHPHQWV LV DFFHSWDEOH '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 TXDQWLW\ YDOXH $GXOW SHGLDWULF IRUPXOD ² 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 ² 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' ² 7KH 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 ² 7KH PLQLPXP FRQFHQWUDWLRQ RU PDVV RI DQDO\WH LQ D JLYHQ PDWUL[ WKDW FDQ EH UHSRUWHG DV D TXDQWLWDWLYH UHVXOW 5HSHDWDELOLW\ ² 9DULDWLRQ 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

UHSHDWDELOLW\ VWDQGDUG GHYLDWLRQ 6' r VWDQGDUG GHYLDWLRQ 56' r

RU UHSHDWDELOLW\ UHODWLYH

5HSURGXFLELOLW\ ² 7KH 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 9LWDPLQ % 2 ULERÀDYLQ ² $Q LVRDOOR[D]LQH ULQJ ÀDYLQ ULQJ VXEVWLWXWHG DW WKH SRVLWLRQ ZLWK D ' ULELW\O VLGH FKDLQ DQG DOO

IRUPV OLVWHG LQ DSSOLFDELOLW\ QRWH DERYH 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 ULERÀDYLQ 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.

© 2015 AOAC INTERNATIONAL

Made with