AOAC CASP Meeting

AOAC SMPR ® 2017.002

5HFRYHU\ .—The fraction or percentage of spiked analyte that is UHFRYHUHG ZKHQ WKH WHVW VDPSOH LV DQDO\]HG XVLQJ WKH HQWLUH PHWKRG 5 Method Performance Requirements See Tables 3 and 4. 6 System Suitability Tests and/or Analytical Quality Control 6XLWDEOH PHWKRGV ZLOO LQFOXGH EODQN FKHFN VDPSOHV DQG FKHFN standards at the lowest point and midrange point of the analytical range. 7 Reference Material(s) See Tables 1 and 2 for sources of reference materials. Refer to Annex F: 'HYHORSPHQW DQG 8VH RI ,Q +RXVH 5HIHUHQFH 0DWHULDOV in Appendix F: *XLGHOLQHV IRU 6WDQGDUG 0HWKRG 3HUIRUPDQFH 5HTXLUHPHQWV 2I¿FLDO 0HWKRGV RI $QDO\VLV RI $2$& ,17(51$7,21$/ WK (G $2$& ,17(51$7,21$/ 5RFNYLOOH 0' 86$ KWWS ZZZ HRPD DRDF RUJ DSSBI SGI 8 Validation Guidance See ³&ODUL¿FDWLRQ RQ 7HVWLQJ 0DWHULDOV IRU &DQQDELQRLG 6035V´ KWWS ZZZ DRDF RUJ $2$&B3URGB,PLV $2$&B'RFV 636)$0 9DOLGDWLRQ*XLGDQFH&ODUL¿FDWLRQIRU6035 B DQGB SGI Method performance should be demonstrated with homogeneous VDPSOHV ,QKHUHQW YDULDWLRQ LQ WKH SODQW PD\ SUHFOXGH RU OLPLW homogeneity for the following reasons: ( a ) they are resinous; FDQQDELQRLGV DUH FRQFHQWUDWHG LQ WKH UHVLQ ZKLFK FDQ FOXPS GXULQJ grinding; ( b EHWZHHQ ÀRZHU YDULDWLRQ FDQ EH KLJK JULQGLQJ PXOWLSOH ÀRZHUV FDQ LPSDFW WKH KRPRJHQHLW\ c ) grinding can LQWURGXFH KHDW ZKLFK ZLOO FDXVH GHJUDGDWLRQ RI FDQQDELGLROLF DFLGV LQWR QHXWUDO IRUPV UHVXOWLQJ LQ OHVV DFFXUDWH UHVXOWV *ULQGLQJ ZRXOG EH WKH EHVW RSWLRQ IRU KRPRJHQHRXV VDPSOHV EXW LQ VRPH FDVHV WKHUH DUH LVVXHV ZLWK FOXPSHG UHVLQ KLJKO\ YDULDEOH VDPSOHV DQG additional grinding would impact the results and lead to inaccurate data. Appendix D: *XLGHOLQHV IRU &ROODERUDWLYH 6WXG\ 3URFHGXUHV WR 9DOLGDWH &KDUDFWHULVWLFV RI D 0HWKRG RI $QDO\VLV 2I¿FLDO 0HWKRGV RI $QDO\VLV RI $2$& ,17(51$7,21$/ WK (G $2$& ,17(51$7,21$/ 5RFNYLOOH 0' 86$ KWWS ZZZ HRPD DRDF RUJ DSSBG SGI Appendix F: *XLGHOLQHV IRU 6WDQGDUG 0HWKRG 3HUIRUPDQFH 5HTXLUHPHQWV 2I¿FLDO 0HWKRGV RI $QDO\VLV RI $2$& ,17(51$7,21$/ WK (G $2$& ,17(51$7,21$/ 5RFNYLOOH 0' 86$ KWWS ZZZ HRPD DRDF RUJ DSSBI SGI AppendixK: *XLGHOLQHV IRU 'LHWDU\ 6XSSOHPHQWV DQG %RWDQLFDOV 2I¿FLDO 0HWKRGV RI $QDO\VLV RI $2$& ,17(51$7,21$/ WK (G $2$& ,17(51$7,21$/ 5RFNYLOOH 0' 86$ KWWS ZZZ HRPD DRDF RUJ DSSBN SGI 9 Maximum Time-to-Result 1RQH Approved by the AOAC Stakeholder Panel on Strategic Food Analytical Methods (SPSFAM) on March 13, 2017. Final Version Date: March 13, 2017.

Standard Method Performance Requirements (SMPRs) for Quantitation of Cannabinoids in Dried Plant Materials

Intended Use: Consensus-Based Reference Method 1 Purpose AOAC SMPRs describe the minimum recommended performance characteristics to be used during the evaluation of a PHWKRG 7KH HYDOXDWLRQ PD\ EH DQ RQ VLWH YHUL¿FDWLRQ D VLQJOH ODERUDWRU\ YDOLGDWLRQ RU D PXOWL VLWH FROODERUDWLYH VWXG\ 6035V are written and adopted by AOAC stakeholder panels composed of UHSUHVHQWDWLYHV IURP WKH LQGXVWU\ UHJXODWRU\ RUJDQL]DWLRQV FRQWUDFW ODERUDWRULHV WHVW NLW PDQXIDFWXUHUV DQG DFDGHPLF LQVWLWXWLRQV AOAC SMPRs are used by AOAC expert review panels in their evaluation of validation study data for method being considered for Performance Tested Methods SM or AOAC 2I¿FLDO 0HWKRGV RI $QDO\VLV SM DQG FDQ EH XVHG DV DFFHSWDQFH FULWHULD IRU YHUL¿FDWLRQ at user laboratories. 2 Applicability The method will be able to identify and quantify individual cannabinoids (as listed in Tables 1 and 2) in dried plant materials. 3 Analytical Technique Any analytical technique(s) that measures the analytes of interest and meets the following method performance requirements is/are acceptable. 'H¿QLWLRQV 'ULHG SODQW PDWHULDOV ²'ULHG ZKROH RU PLOOHG ÀRZHU SODQW material from &DQQDELV VDWLYD and its hybrids. /LPLW RI TXDQWLWDWLRQ /24 .—The minimum concentration or mass of analyte in a given matrix that can be reported as a quantitative result. 4XDQWLWDWLYH PHWKRG .—Method of analysis which response is the amount of the analyte measured either directly (enumeration in D PDVV RU D YROXPH RU LQGLUHFWO\ FRORU DEVRUEDQFH LPSHGDQFH etc.) in a certain amount of sample. 5HSHDWDELOLW\ .—Variation arising when all efforts are made to keep conditions constant by using the same instrument and operator and repeating during a short time period. Expressed as the repeatability standard deviation (SD r ); or % repeatability relative standard deviation (%RSD r ). 5HSURGXFLELOLW\ .—The standard deviation or relative standard deviation calculated from among-laboratory data. Expressed as the reproducibility standard deviation (SD R ); or % reproducibility relative standard deviation (%RSD R ).

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