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5
Stakeholder Comments
O i i l C
P
d Ch
M
r g na omment
ropose ange
y response
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
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
.
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
I agree LOQ for B2 should be raised
to 40.
Stakeholder Comments
Original Comment
Proposed Change
My response
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
to be precised by the review panel.
In EU it is often thiamin choride
(M=300,82) CAS number 59‐43‐8
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
CAS o t iamin c ori e. T e CAS
number of thiamine chloride,
hydrochloride is 67‐03‐8?
is stated in the correct units.