Microsoft Word - Draft OMB Meeting Agenda-April 11 2019

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Example Reviewed and Recognized Criteria for: Quantitative measurement of Vitamin B 12 

in Dietary Supplements  

1. Applicability : Quantitation of multiple forms of active vitamin B12 individually in dietary supplements.

2. Definitions :

Active Vitamin B12 For the purposes of this SMPR, active Vitamin B12 is defined as: Methylcobalamin. CAS number  13422‐55‐4.   See figure 1. Cyanocobalamin.  CAS number 68‐19‐9 .   See figure 2. Adenosylcobalamin.  CAS number 13870‐90‐1.   See figure 3. Hydroxocobalamin.  CAS number 13422‐51‐0.   See figure 4.

Limit of Quantitation (LOQ) The minimum concentration or mass of analyte in a given matrix that can be reported as a quantitative result. 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 (SD r ); or % repeatability relative standard deviation (%RSD r ). Recovery The fraction or percentage of spiked analyte that is recovered when the test sample is analyzed using the entire method. 3. Method Performance Requirements :

LOQ 

< 0.5% 

Range 

>0.1% to 1% >1%

% Recovery 

97 to 102 

98 – 102 

% RSDr  ≤ 2  Reported as individual Vitamin B12 analogs.  ≤ 4 

04/05/2019