QUY CHUN K THUT QUC GIA

V ACID FOLIC C S DNG B SUNG VO THC PHM

National technical regulation on Folic acid for food fortification

I. QUY NH CHUNG
1. Phm vi iu chnh
Quy chun k thut quc gia (sau y gi tt l Quy chun) ny quy nh cc yu cu
k thut v qun l v cht lng, v sinh an ton i vi acid folic c s dng b
sung vo thc phm.
2. i tng p dng
Quy chun ny p dng i vi:
2.1. T chc, c nhn nhp khu, xut khu, sn xut, bun bn v s dng cc
cht b sung st vo thc phm (sau y gi tt l t chc, c nhn).
2.2. C quan qun l nh nc c lin quan.
3 Gii thch t ng v k hiu vit tt:
3.1. Dc in quc t 2006: The International Pharmacopoeia, 4th edition,
WHO 2006.
3.2. M s C.A.S (Chemical Abstracts Service): M s ng k ha cht ti
Hip hi ha hc Hoa k.
3.3. TS (test solution): Dung dch thuc th.
3.4. R (Reagent): thuc th.
3.5. RS (International Chemical Reference Substances): Ha cht tinh khit
chun quc t.
3.6. VS (Volumetric Solution): Dung dch chun .
II. QUY NH K THUT V PHNG PHP TH
1. Yu cu k thut v phng php th i vi acid folic c quy nh ti
ph lc ban hnh km theo Quy chun ny.
2. Cc yu cu k thut quy nh trong Quy chun ny c th theo Dc
in quc t 2006, ngoi tr mt s php th ring c m t trong ph lc; c th
s dng cc phng php th khc tng ng.
3. Ly mu theo hng dn ti Thng t 16/2009/TT-BKHCN ngy 02 thng 6
nm 2009 ca B Khoa hc v Cng ngh v hng dn kim tra nh nc v cht
lng hng ha lu thng trn th trng v cc quy nh khc ca php lut c lin
quan.

III. YU CU QUN L
1. Cng b hp quy
1.1. Acid folic c s dng b sung vo thc phm phi c cng b ph
hp vi cc quy nh ti Quy chun ny.
1.2. Phng thc, trnh t, th tc cng b hp quy c thc hin theo Quy
nh v chng nhn hp chun, chng nhn hp quy v cng b hp chun, cng
b hp quy ban hnh km theo Quyt nh s 24/2007/Q-BKHCN ngy 28 thng 9
nm 2007 ca B trng B Khoa hc v Cng ngh v cc quy nh ca php lut.
2. Kim tra i vi acid folic b sung vo thc phm
Vic kim tra cht lng, v sinh an ton i vi acid folic b sung vo thc
phm phi c thc hin theo cc quy nh ca php lut.
IV. TRCH NHIM CA T CHC, C NHN
1. T chc, c nhn phi cng b hp quy ph hp vi cc yu cu k thut
ti Quy chun ny, ng k bn cng b hp quy ti Cc An ton v sinh thc phm
v bo m cht lng, v sinh an ton theo ng ni dung cng b.
2. T chc, c nhn ch c nhp khu, xut khu, sn xut, bun bn v s dng
acid folic sau khi hon tt ng k bn cng b hp quy v bo m cht lng, v sinh
an ton, ghi nhn ph hp vi cc quy nh ca php lut.
V.

T CHC THC HIN

1. Giao Cc An ton v sinh thc phm ch tr, phi hp vi cc c quan chc

nng c lin quan hng dn trin khai v t chc vic thc hin Quy chun ny.
2. Cn c vo yu cu qun l, Cc An ton v sinh thc phm c trch nhim
kin ngh B Y t sa i, b sung Quy chun ny.
3. Trng hp hng dn ca quc t v phng php th v cc quy nh
ca php lut vin dn trong Quy chun ny c sa i, b sung hoc thay th th
p dng theo vn bn mi.

Ph lc
QUY NH K THUT I VI ACID FOLIC
1. nh ngha
Tn ha hc

Acid N-[4-[[(2-Amino-1,4-dihydro-4-oxo-6-pteridinyl)methyl]
amino]benzoyl]-L-glutamic
Acid N-[p-[[(2-Amino-1,4-dihydro-4-oxo-6-pteridinyl)methyl]
amino]benzoyl]-L-glutamic
Acid Pteroylglutamic

Cng thc phn t

H
N

H2N
N

N
N

H
N

H
N

OH

OH

M s C.A.S.

59-30-3

Cng thc ha hc

C19H19N7O6

Khi lng phn t

441,40

2. Cm quan

Acid folic c dng bt tinh th mu vng hoc vng cam.

Khng mi hoc gn nh khng mi

3. Chc nng

B sung acid folic vo thc phm, chng thiu mu.

4. Yu cu k thut
4.1. nh tnh
tan

Rt t tan trong nc, thc t khng tan trong ethanol (TS)

(~750g/l), trong aceton (R) v ether (R).

Hp th t ngoi

Ph hp th ca dung dch mu th nng 15 g/ml

trong dung mi l dung dch natri hydroxyd 0,1 mol/l (VS)
c 3 cc i hp th ti 256 nm; 283 nm; 365 nm, hp
th quang tng ng l 0,82; 0,80; 0,28 (tt nht l s
dng cuvet o 2 cm, tnh hp th lp cht lng dy 1
cm). T l cng hp th ti cc bc sng 256 nm v
365 nm A256/A365: trong khong 2,80 - 3,00.

Sc k lp mng

Vt chnh thu c trong sc k ca dung dch A phi

tng ng v v tr, hnh dng v mt so vi vt chnh
trong sc k dung dch B.

4.2. tinh khit

Tro sulfat

Khng c qu 2,0 mg/g.

Nc

Khng c thp hn 70,0 mg/g v khng c qu 90,0

mg/g.

Cc Amin t do

T s AT/AB > 6 (Gi tr AT v AB thu c trong php th

nh lng).

4.3. Hm lng

Hm lng C19H19N7O6 khng c thp hn 96,0% v

khng c qu 102,0% tnh theo ch phm khan.

5. Phng php th
5.1. nh tnh
Sc k lp mng

Tin hnh th theo hng dn trong chuyn lun Sc k

lp mng (Mc 1.14.1; Dc in quc t 2006). S dng
silicagel (G) (Silicagel G, bt trng, ng nht; l hn hp
ca silicagel c ht 10-40 m v calci sulfat hemihydrat
khong 130 g/kg) lm pha tnh ph bn mng. Pha ng l
hn hp gm 1-propanol R/ethanol ~750g/l (TS) /dung
dch amoniac ~260g/l (TS) theo t l th tch tng ng
2/1/2.
Dung mi: l hn hp gm methanol (R) /dung dch
amoniac ~260g/l (TS) theo t l th tch tng ng 9/1.
Dung dch A (dung dch mu th): Pha dung dch mu th
trong dung mi nng 0,50 mg/ml.
Dung dch B (dung dch chun): Pha dung dch chun acid
folic RS trong dung mi nng 0,50 mg/ml.
Chm 2 L dung dch A v dung dch B ln bn mng, cho
khai trin sc k trong bung sc k bo ha pha ng.
Sau khi kt thc qu trnh sc k, ly bn mng ra, kh
trong khng kh, kim tra sc k di nh sng t
ngoi (365 nm).

5.2. tinh khit

Tro Sulfat

Tin hnh th theo hng dn trong Dc in quc t

2006 (mc 2.3 chuyn lun Th Tro sulfat).

Nc

Tin hnh th theo hng dn trong Dc in quc t

2006 (mc 2.8 chuyn lun Xc nh nc bng phng
php Karl-Fischer - Phng php A).
Mu th: 0,15 g.

5.3. nh lng
Dung dch T: Cn chnh xc 0,050 g mu th, ha tan
trong 50 ml dung dch natri hydroxyd ~80 g/l (TS), lc u,
v nh mc n 100 ml bng dung dch natri hydroxyd
~80 g/l (TS).
Dung dch T1 (dung dch th) v dung dch B1 (dung dch
trng): ly vo 2 bnh nh mc 100 ml, mi bnh 30 ml
dung dch T, 20 ml Acid hydrocloric ~70 g/l (TS), pha long
n th tch bng nc ct.
Dung dch T2: Ly 60 ml dung dch T1, thm 0,5 g bt km
(R), yn, thnh thong lc u, thc hin nh vy trong
20 pht. Lc dung dch qua giy lc kh, loi b 10 ml dch
lc u tin. Ly 10 ml dch lc tip theo cho vo bnh nh

mc 100 ml, nh mc n th tch bng nc ct.

Ly 5 ml dung dch T2, dung dch B1, nc ct (dung dch
B2), mi dung dch ly ring vo 1 bnh nh mc 25 ml.
Thm vo mi bnh 1 ml nc ct, 1 ml Acid hydrocloric
~70 g/l (TS) v 1 ml dung dch natri nitrit 1 g/l (TS), lc u
v yn trong 2 pht. Sau thm vo mi bnh 1 ml
dung dch amoni sulfamat 5 g/l (TS), lc u v yn
trong 2 pht. Thm vo mi bnh 1 ml dung dch N-(1naphtyl) ethylendiamin hydroclorid 1 g/l (TS), lc u v
yn trong 10 pht, pha long n th tch bng nc
ct.
o hp th quang ca dung dch T2 v dung dch B1 so
vi dung dch B2 ti bc sng cc i khong 550nm.
Ghi gi tr hp th quang AT v AB tng ng.
Tin hnh tng t i vi chun acid folic RS v ghi li
hp th quang AS v ABS.
Tnh hm lng (%) C19H19N7O6 trong mu th theo cng
thc sau:
(%) = 100 (10AT - AB)/(10AS - ABS)
Trong trng hp cn thit c th nhn kt qu vi hm
lng (%) C19H19N7O6 cng b trong cht chun.
6. Bao gi v bo qun Gi trong bao b kn, trnh nh sng.