APAC SPSFAM Mid Year 2016

SMPR Key Points

• Repeatability ‐ 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 (SDr); or % repeatability relative standard deviation (%RSDr).  • Reproducibility ‐ The standard deviation or relative standard deviation calculated from among‐ laboratory data. Expressed as the reproducibility standard deviation (SDR); or % reproducibility  relative standard deviation (% RSDR).  • Recovery Factor ‐ The fraction or percentage of the analyte that is recovered when the test sample is  analyzed using the entire method. 

Comments Submitted (if any)

Kombucha SMPR:  Comment 1 

Kombucha SMPR:  Comment 2 

SMPR  Comments  for:

Kombucha

SMPRComments  for:

Kombucha

Submitter"s 

ArmenMirzoian

Submitter"s  Name

Name

KathyStenerson

Submitter"s  Email  Address

Submitter"s  EmailAddress

armen.mirzoian@ttb.gov

katherine.stenerson@sial.com

Organization

MilliporeSigma

Organization TTB

Typesof  Comments

Typesof  Comments

Technical

Technical

LineNumbers (If  Applicable)

51

Line  Numbers (If  Applicable)

66‐67

Theanalytical range is toowide, that is if this refers toaworking range.  Itwill  bedifficult formostanalytical techniques tobe linear in thiswideofa range.  Since the limit tobe considerednonalcoholic is0.5%ABV, goingup to2.8%  really shouldnotbenecessary.

Comments  (Justificationof  Change(s))

Sigma‐Aldrich200ProofEthanol cannotbeusedasa referencematerialbecause it  doesnotarrivewithcertificateofanalysis that indicatesexact concentrationof  ethanol. It canbeused in some cases forpreparationof standardsonlyafteraccurate 

Comments  (Justification  ofChange(s))

concentrationofethanol isdeterminedbymeansof specific gravity. 

Proposed  Change(s)

Reduce this range to .1% to1%ABV

Proposed  Change(s)

Remove thementionof SigmaAldrich200proofethanolasa referencematerial

Chair /CSOResponse: 

Chair /CSOResponse:

Thiswasdiscussedby theworkinggroup andamajorityof theworkinggroupmembersagreed to  leave the Sigma‐Aldrichmaterialon the listbecause it isa veryhigh concentration  (>99.5%)material that canbediluted to lower concentrationsatwhichanyminordeviations in the  claimed concentrationdonotmatter.  Perhapsaparenthetical statement to theeffect that “this  productdoesnotcomewitha certificateofanalysis” canbeadded to the SMPR.  This issue canbe  re‐examinedwhen the StakeholderPanelmeets.

This iswhatwearehaving todo since theonly available reference standardwe can find isa1.0%.  We  areusing the200Proof fromAldrichand standardizing itusing theCertified1% standard.Sam