Review Team (February 2016)

AOAC SMPR 2015.005

Table 1. Method performance requirements a Analytical range

10–2000 b

Limit of quantitation (LOQ)

”

b

Standard Method Performance Requirements SM (SMPRs) for Total Vitamin B 6 (Pyridoxine) in Infant 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 6 (pyridoxine) in all forms of infant, adult, and/or pediatric formula (powders, ready-to-feed liquids, and liquid concentrates). Total B 6 GH¿QHG DV WKH VXP RI pyridoxine(CAS No. 65-23-6), pyridoxal (CAS No. 66-72-8), S\ULGR[DPLQH &$6 1R DQG WKH SKRVSKRU\ODWHG IRUPV S\ULGR[DO SKRVSKDWH &$6 1R DQG S\ULGR[DPLQH SKRVSKDWH &$6 1R $OO GDWD VKRXOG EH PDVV corrected and expressed as pyridoxine. 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 QXPEHU RI UHSOLFDWH PHDVXUHG TXDQWLW\ YDOXHV DQG D UHIHUHQFH 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 ²%UHDVW PLON VXEVWLWXWH VSHFLDOO\ PDQXIDFWXUHG 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 UHSHDWDELOLW\ VWDQGDUG GHYLDWLRQ 6' 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 ). 9LWDPLQ % 6 S\ULGR[LQH ²$OO PHWK\O K\GUR[\ K\GUR[\ PHWK\O S\ULGLQH FRPSRXQGV ZLWK HTXLYDOHQW ELRORJLFDO DFWLYLW\ RI S\ULGR[LQH 31 PHWK\O K\GUR[\ ELV K\GUR[\PHWK\O pyridine in rats. See DSSOLFDELOLW\ VWDWHPHQW DERYH &$6 1R IRU pyridoxine: 65-23-6). 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 LQIDQW DGXOW QXWULWLRQDO SRZGHU SUHSDUHG E\ D PDQXIDFWXUHU RI 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 vitamin B 6 (pyridoxine). 7 Validation Guidance 5HFRPPHQGHG OHYHO RI YDOLGDWLRQ 2I¿FLDO 0HWKRGV RI $QDO\VLV SM . 8 Maximum Time-to-Result No maximum time. 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