March 17, 2015-SP

Stakeholder Comments

M

y response

O i i l C r g na omment 

P ropose ange d Ch

I would agree that all Vitamin B3  data must be mass corrected and  reported consistently.  I would also  agree that the reported form should  be Nicotinic Acid.  The correction  should be to footnote 1 as follows:  Total B 3 defined as the sum of  Nicotinic Acid and Nicotinamide.  Total B 3 should be expressed as the  Nicotinic Acid form .   I agree LOQ for B2 should be raised  to 40. 

The mode of expression of the B3  result is not precised 

Total B3 is the sum of nicotinic acid  and nicotinamide. All data should be  mass corrected and expressed as  nicotinic acid 

In the other SMPR the lower value of  the analytical range is equal to the  limit of quantification. For riboflavin  it is not the case 

Change the lower value of the  analytical range to 20 or change the  LOQ to 40 

Stakeholder Comments

My response

Original Comment

Proposed Change

I believe this was discussed and the  consensus was to report Thiamine  as the ion to avoid any confusion.  I  agree the CAS number should be  corrected to reflect the ion form  which is 70‐16‐6. As for footnote 1 it  may also be wise to modify by  stating thiamine ion. The SRM value

The formula of thiamin, as the  chemical structure, is an ion  (M=265,37) a lot of regulations use  thiamine chloride (M=300,82). some  databases use thiamine chloride,  hydrochloride (M=337,28) The CAS  number of line 56 (59‐43‐8) is the  f h hl d h CAS o t iamin c ori e. T e CAS  number of thiamine chloride,  hydrochloride is 67‐03‐8? 

to be precised by the review panel.  In EU it is often thiamin choride  (M=300,82) CAS number 59‐43‐8 

is stated in the correct units.

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