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CNG HA X HI CH NGHA VIT NAM

QCVN 4-1: 2010/BYT

QUY CHUN K THUT QUC GIA


V PH GIA THC PHM - CHT IU V
National technical regulation
on Food Additive - Flavour Enhancer

H NI - 2010

Li ni u
QCVN 4-1 :2010/BYT do Ban son tho quy chun k
thut quc gia v Ph gia thc phm v cht h tr ch
bin bin son, Cc An ton v sinh thc phm trnh duyt
v c ban hnh theo Thng t s 18/2010/TT-BYT
ngy 20 thng 5 nm 2010 ca B trng B Y t.

QUY CHUN K THUT QUC GIA


V PH GIA THC PHM - CHT IU V
National technical regulation on Food additive Flavour enhancer

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 cc cht iu v c s dng vi
mc ch lm ph gia 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 iu v lm ph gia 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 ch vit tt:
3.1. Cc cht iu v: l ph gia thc phm c s dng vi mc ch tng
hng v ca cc sn phm thc phm.
3.2. JECFA monograph 1 - Vol. 4 (JECFA monographs 1 - Combined
compendium of food addiditive specifications; Joint FAO/WHO expert committee on
food additives; Volume 4 - Analytical methods, test procedures and laboratory
solutions used by and referenced in the food additive specifications; FAO, 2006): Cc
yu cu k thut i vi ph gia thc phm, Tp 4 Cc phng php phn tch, quy
trnh th nghim, dung dch th nghim c s dng (hoc tham chiu) trong yu
cu k thut i vi ph gia thc phm; JECFA bin son; FAO ban hnh nm 2006.
3.3. M s C.A.S (Chemical Abstracts Service): M s ng k ha cht ca
Hip hi Ha cht Hoa K.
3.4. TS (test solution): Dung dch thuc th.
3.5. ADI (Acceptable daily intake): Lng n vo hng ngy chp nhn c.
3.6. INS (International numbering system): H thng m s quc t v ph gia
thc phm.
II. YU CU K THUT, PHNG PHP TH V LY MU
1. Yu cu k thut v phng php th i vi cc cht iu v c quy nh
ti cc ph lc ban hnh km theo Quy chun ny nh sau:
1.1.

Ph lc 1:

Yu cu k thut v phng php th i vi acid LGlutamic

QCVN 4-1 : 2010/BYT


1.2.

Ph lc 2:

Yu cu k thut v phng php th i vi mononatri


L-glutamat

1.3.

Ph lc 3:

Yu cu k thut v phng php th i vi monokali


L-glutamat

1.4.

Ph lc 4:

Yu cu k thut v phng php th i vi calci di-Lglutamat

1.5.

Ph lc 5:

Yu cu k thut v phng php th i vi acid 5'guanylic

1.6.

Ph lc 6:

Yu cu k thut v phng php th i vi acid 5'inosinic

1.7.

Ph lc 7:

Yu cu k thut v phng php th i vi maltol

1.8.

Ph lc 8:

Yu cu k thut v phng php th i vi ethyl


maltol

2. Cc yu cu k thut quy nh trong Quy chun ny c th theo JECFA


monograph 1 - Vol. 4, ngoi tr mt s php th ring c m t trong cc ph lc.
Cc phng php th c hng dn trong Quy chun ny khng bt buc phi
p dng, 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. Cc cht iu v 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 cht iu v
Vic kim tra cht lng, v sinh an ton i vi cc cht iu v phi thc hin
theo cc quy nh ca php lut.

QCVN 4-1 : 2010/BYT


IV. TRCH NHIM CA T CHC, C NHN
1. T chc, c nhn phi cng b hp quy ph hp vi cc quy nh 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
cc cht iu v 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.

QCVN 4-1 : 2010/BYT


Ph lc 1
YU CU K THUT V PHNG PHP TH
I VI ACID L-GLUTAMIC
1. Tn khc, ch s

L-glutamic acid, Glutamic acid


INS 620
ADI khng gii hn

2. nh ngha
Tn ha hc

Acid L-glutamic; Acid L-(+)-glutamic, acid L-2-aminopentandioic; Acid L-alpha-aminoglutaric

M s C.A.S.

56-86-0

Cng thc phn t

C5H9NO4

Cng thc cu to

HO

OH
NH2

Khi lng phn t

147,13

3. Cm quan

Tinh th hoc bt tinh th mu trng, hoc khng mu.

4. Chc nng

Cht iu v, thay th mui.

5. Yu cu k thut
5.1. nh tnh
tan

t tan trong nc, thc t khng tan trong ethanol v ether.

Glutamat

Phi c phn ng c trng ca glutamat.

5.2. tinh khit


Gim khi lng khi lm Khng c qu 0,2%
(Sy ti 80 oC trong 3 gi).
kh
pH

Dung dch bo ha mu th c pH trong khong 3,0 - 3,5.

Gc quay cc ring

Dung dch mu th 10% (kl/tt) trong acid hydrocloric 2 N c


[ ]D20 trong khong +31,5 n +32,2o

Tro sulfat

Khng c qu 0,2%.

Clorid

Khng c qu 0,2%.

Acid pyrrolidon
carboxylic

t yu cu (m t trong phn phng php th).

Arsen

Khng c qu 3,0 mg/kg

QCVN 4-1 : 2010/BYT


Ch

Khng c qu 1,0 mg/kg.

5.3. Hm lng
C5H9NO4

Khng thp hn 99,0% tnh theo ch phm lm kh.

6. Phng php th
6.1 tinh khit
Tro sulfat

Th theo JECFA monograph 1 - Vol.4 - Phng php I,


cn 1 g mu.

Clorid

Th theo JECFA monograph 1 - Vol.4 - Cn 0,07 g mu


th, tin hnh theo hng dn trong chuyn lun th gii
hn clorid, s dng 0,4 ml dung dch acid hydrocloric 0,01
N lm mu chng.

Acid pyrrolidon
carboxylic

- Th theo JECFA monograph 1 - Vol.4. Phng php sc


k bn mng.
- Mu th : Chun b dung dch mu th 0,5%. Ly 2 l.
- Chun : pha dung dch chun mononatri glutamat 0,5%
cha 2,5 mg acid pyrrolidon carboxylic.
- Dung mi: hn hp n-butanol/acid acetic bng/nc, t l
th tch 2/1/1.
- Pha tnh hp ph : Silicagel.
Dung dch h tinh bt-kali iodid : un nng 0,5 g tinh bt
trong 50 ml nc khuy u n khi h ha. ngui,
thm 0,5 g kali iodid v thm nc n 100 ml.
- Tin hnh chy sc k theo hng dn trong chuyn lun
sc k bn mng (cc phng php phn tch). Dng qu
trnh sc k khi tuyn dung mi cch im xut pht
khong 10 cm, kh dung mi trong khng kh, khong
30 pht.
- ng thi, chun b bung sc k tng t, t vo 1 cc
thy tinh dung tch 50 ml, cho vo cc 3 g natri hypoclorid,
thm t t vo cc 1 ml acid hydrocloric to kh clor,
y np v yn trong 30 giy to mi trng kh clor
trong bung. t bn mng kh vo bung sc k,
y np v yn trong 20 pht. Ly bn mng ra khi
bung, yn 10 pht trong khng kh v xt ethanol ln
bn mng. Sau khi kh, xt dung dch h tinh bt-kali
iodid ln bn mng, quan st di nh sng thng ngay
sau khi vt chun xut hin.
Yu cu : Trong sc k ca mu th khng c c vt
tng ng vt acid pyrrolidon carboxylic trong sc k
ca chun ( nhy 0,2%).

Arsen

- Th JECFA monograph 1 - Vol.4, Phng php II.

Ch

- Th theo JECFA monograph 1 - Vol.4.


- Xc nh bng k thut hp th nguyn t thch hp cho
hm lng quy nh. La chn c mu th v phng
5

QCVN 4-1 : 2010/BYT


php chun b mu da trn nguyn tc ca phng php
m t ti JECFA monograph 1 - Vol.4 phn cc phng
php phn tch cng c.
6.2. nh lng
Cn khong 200 mg (chnh xc n mg) mu th c
lm kh trc, ha tan trong 6 ml acid formic, thm 100 ml
acid acetic bng. Chun vi dung dch acid percloric 0,1
N, xc nh im kt thc chun bng o th. Tin hnh
lm mu trng song song hiu chnh nn.
Mi ml dung dch acid percloric 0,1 N tng ng vi
14,713 mg C5H9NO4.

QCVN 4-1 : 2010/BYT


Ph lc 2
YU CU K THUT V PHNG PHP TH
I VI MONONATRI L-GLUTAMAT
1. Tn khc, ch s

Monosodium L-glutamate, Sodium glutamate


INS 621
ADI khng gii hn

2. nh ngha
Tn ha hc

Mononatri L-glutamat monohydrat; Mui mononatri ca acid


glutamic, monohydrat

M s C.A.S.

6106-04-3

Cng thc phn t

C5H8NNaO4.H2O

Cng thc cu to

NH2
HO

O
O

Na +

Khi lng phn t

187,13

3. Cm quan

Tinh th hoc bt tinh th trng, thc t khng mi.

4. Chc nng

Cht iu v.

5. Yu cu k thut
5.1. nh tnh
tan

D tan trong nc, t tan trong ethanol, thc t khng tan


trong ether.

Glutamat

Phi c phn ng c trng ca glutamat.

Natri

Phi c phn ng c trng ca natri.

5.2. tinh khit


Gim khi lng khi lm
kh

Khng c qu 0,5% (Sy ti 98oC trong 5 gi).

pH

Dung dch mu th 1/50 c pH trong khong 6,7 - 7,2.

Gc quay cc ring

Dung dch mu th 10% (kl/tt) trong acid hydrocloric 2 N c


[ ]D20 trong khong +24,8 n +25,3o

Clorid

Khng c qu 0,2%.

Acid pyrrolidon carboxylic

t yu cu (m t trong phn phng php th).

Ch

Khng c qu 1,0 mg/kg.

QCVN 4-1 : 2010/BYT


5.3. Hm lng
C5H8NNaO4.H2O

Khng thp hn 99,0% tnh theo ch phm lm kh.

6. Phng php th
6.1 tinh khit
Clorid

Th theo JECFA monograph 1 - Vol.4 - Cn 0,07 g mu


th, tin hnh theo hng dn trong chuyn lun th gii
hn clorid, s dng 0,4 ml dung dch acid hydrocloric 0,01
N lm mu chng.

Acid pyrrolidon carboxylic

- Th theo JECFA monograph 1 - Vol.4. Phng php sc


k bn mng.
- Mu th : Chun b dung dch mu th 0,5%. Ly 2 l.
- Chun : pha dung dch chun mono natri glutamat 0,5%
cha 2,5 mg acid pyrrolidon carboxylic.
- Dung mi: hn hp n-butanol/acid acetic bng/nc, t l
th tch 2/1/1.
- Pha tnh hp th : Silicagel.
Dung dch h tinh bt-kali iodid : un nng 0,5 g tinh bt
trong 50 ml nc khuy u n khi h ha. ngui,
thm 0,5 g kali iodid v thm nc n 100 ml.
- Tin hnh chy sc k theo hng dn trong chuyn lun
sc k bn mng (cc phng php phn tch). Dng qu
trnh sc k khi tuyn dung mi cch im xut pht
khong 10 cm, kh dung mi trong khng kh, khong
30 pht.
- ng thi, chun b bung sc k tng t, t vo 1 cc
thy tinh dung tch 50 ml, cho vo cc 3 g natri hypoclorid,
thm t t vo cc 1 ml acid hydrocloric to kh clor, y
np v yn trong 30 giy to mi trng kh clor
trong bung. t bn mng kh vo bung sc k,
y np v yn trong 20 pht. Ly bn mng ra khi
bung, yn 10 pht trong khng kh v xt ethanol ln
bn mng. Sau khi kh, xt dung dch h tinh bt-kali
iodid ln bn mng, quan st di nh sng thng ngay
sau khi vt chun xut hin.
Yu cu : Trong sc k ca mu th khng c c vt
tng ng vt acid pyrrolidon carboxylic trong sc k
ca chun ( nhy 0,2%).

Ch

- Th theo JECFA monograph 1 - Vol.4.


- Xc nh bng k thut hp th nguyn t thch hp cho
hm lng quy nh. La chn c mu th v phng
php chun b mu da trn nguyn tc ca phng php
m t ti JECFA monograph 1 - Vol.4 phn cc phng
php phn tch cng c.

6.2. nh lng
Cn khong 200 mg (chnh xc n mg) mu th c
8

QCVN 4-1 : 2010/BYT


lm kh trc, ha tan trong 6 ml acid formic, thm 100 ml
acid acetic bng. Chun vi dung dch acid percloric 0,1
N, xc nh im kt thc chun bng o th. Tin hnh
lm mu trng song song hiu chnh nn.
Mi ml dung dch acid percloric 0,1 N tng ng vi
9,356 mg C5H9NNaO4.H2O.

QCVN 4-1 : 2010/BYT


Ph lc 3
YU CU K THUT V PHNG PHP TH
I VI MONOKALI L-GLUTAMAT
1. Tn khc, ch s

Monopotassium L-glutamate, Potassium glutamate; MPG


INS 622
ADI khng gii hn

2. nh ngha
Tn ha hc

Monokali L-glutamat monohydrat; Mui monokali ca acid


glutamic monohydrat

M s C.A.S.

19473-49-5

Cng thc phn t

C5H8NKO4.H2O

Cng thc cu to

NH2
HO

O
O

Khi lng phn t

K+

203,24

3. Cm quan
4. Chc nng

Cht iu v, thay th mui.

5. Yu cu k thut
5.1. nh tnh
tan

D tan trong nc, t tan trong ethanol.

Glutamat

Phi c phn ng c trng ca glutamat.

Kali

Phi c phn ng c trng ca kali.

5.2. tinh khit


Gim khi lng khi lm
kh

Khng c qu 0,2% (Sy ti 80oC trong 5 gi).

pH

Dung dch mu th 1/50 c pH trong khong 6,7 - 7,3.

Gc quay cc ring

Dung dch mu th 10% (kl/tt) trong acid hydrocloric 2 N c


[ ]D20 trong khong +22,5 n +24,0o

Clorid

Khng c qu 0,2%.

Acid pyrrolidon carboxylic

t yu cu (m t trong phn phng php th).

Ch

Khng c qu 1,0 mg/kg.

10

QCVN 4-1 : 2010/BYT


5.3. Hm lng
C5H8NKO4.H2O

Khng thp hn 99,0% tnh theo ch phm lm kh.

6. Phng php th
6.1 tinh khit
Clorid

- Th theo JECFA monograph 1 - Vol.4


- Cn 0,07 g mu th, tin hnh theo hng dn trong
chuyn lun th gii hn clorid, s dng 0,4 ml dung dch
acid hydrocloric 0,01 N lm mu chng.

Acid pyrrolidon carboxylic

- Th theo JECFA monograph 1 - Vol.4. Phng php sc


k bn mng.
- Mu th : Chun b dung dch mu th 0,5%. Ly 2 l.
- Chun : pha dung dch chun mono natri glutamat 0,5%
cha 2,5 mg acid pyrrolidon carboxylic.
- Dung mi: hn hp n-butanol/acid acetic bng/nc, theo
t l th tch tng ng 2/1/1.
- Pha tnh hp th : Silicagel.
Dung dch h tinh bt-kali iodid : un nng 0,5 g tinh bt
trong 50 ml nc khuy u n khi h ha. ngui,
thm 0,5 g kali iodid v thm nc n 100 ml.
- Tin hnh chy sc k theo hng dn trong chuyn lun
sc k bn mng (cc phng php phn tch). Dng qu
trnh sc k khi tuyn dung mi cch im xut pht
khong 10 cm, kh dung mi trong khng kh, khong
30 pht.
- ng thi, chun b bung sc k tng t, t vo 1 cc
thy tinh dung tch 50 ml, cho vo cc 3 g natri hypoclorid,
thm t t vo cc 1 ml acid hydrocloric to kh clor, y
np v yn trong 30 giy to mi trng kh clor
trong bung. t bn mng kh vo bung sc k,
y np v yn trong 20 pht. Ly bn mng ra khi
bung, yn 10 pht trong khng kh v xt ethanol ln
bn mng. Sau khi kh, xt dung dch h tinh bt-kali
iodid ln bn mng, quan st di nh sng thng ngay
sau khi vt chun xut hin.
Yu cu : Trong sc k ca mu th khng c c vt
tng ng vt acid pyrrolidon carboxylic trong sc k
ca chun ( nhy 0,2%).

Ch

- Th theo JECFA monograph 1 - vol. 4


- Xc nh bng k thut hp th nguyn t thch hp cho
hm lng quy nh. La chn c mu th v phng
php chun b mu da trn nguyn tc ca phng php
m t ti JECFA monograph 1 - Vol.4 phn cc phng
php phn tch cng c.

11

QCVN 4-1 : 2010/BYT


6.2. nh lng
Cn khong 200 mg (chnh xc n mg) mu th c
lm kh trc, ha tan trong 6 ml acid formic, thm 100 ml
acid acetic bng. Chun vi dung dch acid percloric 0,1
N, xc nh im kt thc chun bng o th. Tin hnh
lm mu trng song song hiu chnh nn
Mi ml dung dch acid percloric 0,1 N tng ng vi
10,162 mg C5H8KNO4.H2O.

12

QCVN 4-1 : 2010/BYT


Ph lc 4
YU CU K THUT V PHNG PHP TH
I VI CALCI di-L-GLUTAMAT
1. Tn khc, ch s

Monocalcium di-L-glutamate, Calcium glutamate;


INS 623
ADI khng gii hn

2. nh ngha
Tn ha hc

Monocalci di-L-glutamat;

M s C.A.S.

19238-49-4

Cng thc phn t

C10H16CaN2O8 . xH2O (x = 0, 1, 2, 6 hoc 4)

Cng thc cu to

NH2
HO

O
O

Ca + +

O
2

Khi lng phn t

332,32 (dng khan)

3. Cm quan

Tinh th hoc bt tinh th trng, thc t khng mi.

4. Chc nng

Cht iu v, thay th mui.

5. Yu cu k thut
5.1. nh tnh
tan

D tan trong nc.

Glutamat

Phi c phn ng c trng ca glutamat.

Calci

Phi c phn ng c trng ca calci.

5.2. tinh khit


Nc

Khng c qu 19,0%

Gc quay cc ring

Dung dch mu th 10% (kl/tt) trong acid hydrocloric 2 N c


[ ]D20 trong khong +27,4 n +29,2o

Clorid

Khng c qu 0,2%.

Acid pyrrolidon carboxylic

t yu cu (m t trong phn phng php th).

Ch

Khng c qu 1,0 mg/kg.

5.3. Hm lng
C10H16CaN2O8

Khng thp hn 98,0% v khng c qu 102,0% tnh


theo ch phm khan.

13

QCVN 4-1 : 2010/BYT


6. Phng php th
6.1 tinh khit
Nc

- Th theo JECFA monograph 1 - Vol.4


- Phng php Karl Fischer.

Clorid

- Th theo JECFA monograph 1 - Vol.4


- Cn 0,07 g mu th, tin hnh theo hng dn trong
chuyn lun th gii hn clorid, s dng 0,4 ml dung dch
acid hydrocloric 0,01 N lm mu chng.

Acid pyrrolidon carboxylic

- Th theo JECFA monograph 1 - Vol.4. Phng php sc


k bn mng.
- Mu th : Chun b dung dch mu th 0,5%. Ly 2 l.
- Chun : pha dung dch chun mono natri glutamat 0,5%
cha 2,5 mg acid pyrrolidon carboxylic.
- Dung mi: hn hp n-butanol/acid acetic bng/nc, t l
th tch 2/1/1.
- Pha tnh hp th : Silicagel.
Dung dch h tinh bt-kali iodid : un nng 0,5 g tinh bt
trong 50 ml nc khuy u n khi h ha. ngui,
thm 0,5 g kali iodid v thm nc n 100 ml.
- Tin hnh chy sc k theo hng dn trong chuyn lun
sc k bn mng (cc phng php phn tch). Dng qu
trnh sc k khi tuyn dung mi cch im xut pht
khong 10 cm, kh dung mi trong khng kh, khong
30 pht.
- ng thi, chun b bung sc k tng t, t vo 1 cc
thy tinh dung tch 50 ml, cho vo cc 3 g natri hypoclorid,
thm t t vo cc 1 ml acid hydrocloric to kh clor, y
np v yn trong 30 giy to mi trng kh clor
trong bung. t bn mng kh vo bung sc k,
y np v yn trong 20 pht. Ly bn mng ra khi
bung, yn 10 pht trong khng kh v xt ethanol ln
bn mng. Sau khi kh, xt dung dch h tinh bt-kali
iodid ln bn mng, quan st di nh sng thng ngay
sau khi vt chun xut hin.
Yu cu : Trong sc k ca mu th khng c c vt
tng ng vt acid pyrrolidon carboxylic trong sc k
ca chun ( nhy 0,2%).

Ch

- Th theo JECFA monograph 1 - Vol.4.


- Xc nh bng k thut hp th nguyn t thch hp cho
hm lng quy nh. La chn c mu th v phng
php chun b mu da trn nguyn tc ca phng php
m t ti JECFA monograph 1 - Vol.4 phn cc phng
php phn tch cng c.

14

QCVN 4-1 : 2010/BYT


6.2. nh lng
Cn khong 250 mg (chnh xc n mg) mu th c
lm kh trc, ha tan trong 6 ml acid formic, thm 100 ml
acid acetic bng. Chun vi dung dch acid percloric 0,1
N, xc nh im kt thc chun bng o th. Tin hnh
lm mu trng song song hiu chnh nn
Mi ml dung dch acid percloric 0,1 N tng ng vi
8,308 mg C10H16CaN2O8. Tnh hm lng da trn ch
phm khan.

15

QCVN 4-1 : 2010/BYT


Ph lc 5
YU CU K THUT V PHNG PHP TH I VI ACID 5-GUANYLIC
1. Tn khc, ch s

5-Guanylic acid; Guanylic acid; GMP


INS 626
ADI khng gii hn

2. nh ngha
Tn ha hc

Acid Guanosin-5-monophosphoric

M s C.A.S.

85-32-5

Cng thc phn t

C10H14N5O8P

Cng thc cu to

Khi lng phn t

363,22

3. Cm quan

Tinh th trng hoc khng mu, bt tinh th trng; khng


mi

4. Chc nng

Cht iu v

5. Yu cu k thut
5.1. nh tnh
tan

t tan trong nc, thc t khng tan trong ethanol.

Ph hp th quang

Dung dch mu th 1/50000 trong acid hydrocloric 0,01 N


c cc i hp th ti 256 2 nm. T s A256/A260 trong
khong t 0,95 n 1,03 v t s A280/A260 trong khong t
0,63 n 0,71.

Ribose

Phi c phn ng c trng ca ribose.

Phosphat hu c

Phi c phn ng c trng ca phosphat hu c.

5.2. tinh khit


Gim khi lng khi lm
kh

Khng c qu 1,5%
(sy 120 oC trong 4 gi).

pH

Dung dch mu th 1/400 c pH t 1,5 n 2,5 .

16

QCVN 4-1 : 2010/BYT


Cc tp cht ngoi lai c
lin quan

Khng pht hin bng phng php sc k.

Ch

Khng c qu 1,0 mg/kg.

5.3. Hm lng
C10H14N5O8P

Khng thp hn 97,0% v khng c qu 102,0% tnh


theo ch phm lm kh.

6. Phng php th
6.1. nh tnh
Phosphat hu c

- Th theo hng dn ti JECFA monograph 1 - Vol.4


- Dch th l dung dch mu th 1/400.

6.2. tinh khit


Cc tp cht ngoi lai c
lin quan

- Th theo hng dn ti JECFA monograph 1 - Vol.4

Ch

Th theo hng dn ti JECFA monograph 1 - Vol.4. Xc


nh bng k thut hp th nguyn t thch hp cho hm
lng quy nh. La chn c mu th v phng php
chun b mu da trn nguyn tc ca phng php m t
ti JECFA monograph 1 - Vol.4 phn cc phng php
phn tch cng c.

- dng 2 l dung dch mu th 1/400.

6.3. nh lng
Cn khong 0,5 g (chnh xc n 0,1 mg) mu th ha tan
trong acid hydrocloric 0,01 N v nh mc n 1000 ml. ly
10 ml dung dch ny pha long vi acid hydrocloric 0,01 N
va thu c 250 ml. Xc nh hp th quang ca
dung dch ny trong cuvet 1 cm ti bc sng 260 nm v
s dng dung dch acid hydrocloric 0,01 N lm mu chng.
Tnh hm lng % C10H14N5O8P trong mu th theo cng
thc sau:

%=

A X
235

250000
Khi lng mu
(mg)

X
100
100
100- gim khi lng khi
lm kh (%)

17

QCVN 4-1 : 2010/BYT


Ph lc 6
YU CU K THUT V PHNG PHP TH I VI ACID 5-INOSINIC
1. Tn khc, ch s

5- Inosinic acid; Inosinic acid; IMP


INS 630
ADI khng gii hn

2. nh ngha
Tn ha hc

Acid Inosin-5-monophosphoric

M s C.A.S.

131-99-7

Cng thc phn t

C10H13N4O8P

Cng thc cu to

Khi lng phn t

348,21

3. Cm quan

Tinh th trng hoc khng mu, bt tinh th trng; khng


mi

4. Chc nng

Cht iu v

5. Yu cu k thut
5.1. nh tnh
tan

D tan trong nc, t tan trong ethanol.

Ph hp th quang

Dung dch mu th 1/50000 trong acid hydrocloric 0,01 N


c cc i hp th ti 250 2 nm. T s A250/A260 trong
khong t 1,55 n 1,65 v t s A280/A260 trong khong t
0,20 n 0,30.

Ribose

Phi c phn ng c trng ca ribose.

Phosphat hu c

Phi c phn ng c trng ca phosphat hu c.

5.2. tinh khit


Gim khi lng khi lm
kh

Khng c qu 3,0% (sy ti 120 oC trong 4 gi).

pH

Dung dch mu th 1/20 c pH t 1,0 n 2,0.

Cc tp cht ngoi lai c


lin quan

Khng pht hin bng phng php sc k.

18

QCVN 4-1 : 2010/BYT


Ch

Khng c qu 1,0 mg/kg.

5.3. Hm lng
C10H13N4O8P

Khng thp hn 97,0% v khng c qu 102,0% tnh


theo ch phm lm kh.

6. Phng php th
6.1. nh tnh
Phosphat hu c

- Th theo hng dn ti JECFA monograph 1 - Vol.4


- Dch th l dung dch mu th 1/400.

6.2. tinh khit


Cc tp cht ngoi lai c
lin quan

- Th theo hng dn ti JECFA monograph 1 - Vol.4

Ch

- Th theo hng dn ti JECFA monograph 1 - Vol.4.


- Xc nh bng k thut hp th nguyn t thch hp cho
hm lng quy nh. La chn c mu th v phng
php chun b mu da trn nguyn tc ca phng php
m t trong JECFA monograph 1 - Vol.4 phn cc phng
php phn tch cng c.

- dng 1 l dung dch mu th 1/200.

6.3. nh lng
Cn khong 0,5 g (chnh xc n 0,1 mg) mu th ha tan
trong acid hydrocloric 0,01 N v nh mc n 1000 ml. ly
10 ml dung dch ny pha long vi acid hydrocloric 0,01 N
va thu c 250 ml. Xc nh hp th quang ca
dung dch trong cuvet 1 cm ti bc sng 250 nm v s
dng dung dch acid hydrocloric 0,01 N lm mu chng.
Tnh hm lng % C10H13N4O8P trong mu th theo cng
thc sau:

%=

A
349

250000
Khi lng mu
(mg)

100
100- gi tr gim khi
lng khi lm kh (%)

100

19

QCVN 4-1 : 2010/BYT


Ph lc 7
YU CU K THUT V PHNG PHP TH I VI MALTOL
1. Tn khc, ch s
2. nh ngha

INS 636
ADI = 0 - 1 mg/kg th trng
Maltol thu c bng cch tng hp ha hc

Tn ha hc

3-hydroxy-2-methyl-4-pyron

M s C.A.S.

118-71-8

Cng thc ha hc

C6H6O3

Cng thc cu to

Khi lng phn t

126,11

3. Cm quan

Bt tinh th trng c mi caramel b ngo ng.

4. Chc nng

Cht iu v, tr hng, hng liu.

5. Yu cu k thut
5.1. nh tnh
tan

t tan trong nc, tan trong ethanol v propylen glycol.

Khong nng chy

160o - 164o.

Hp th t ngoi

Ph hp th t ngoi ca dung dch mu th 10 mg/l trong


acid hydrocloric 0,1 N c 1 cc i hp th ti 274 nm.

5.2. tinh khit


Nc

Khng c qu 0,5%

Tro sulfat

Khng c qu 0,2%. (Cn 5 g mu).

Ch

Khng c qu 1,0 mg/kg.

5.3. Hm lng C6H6O3

Khng thp hn 99,0% tnh theo ch phm khan.

6. Phng php th
6.1. tinh khit
Nc

- Th theo hng dn ti JECFA monograph 1 - Vol.4.


- Phng php Karl-Fischer.

Tro sulfat

- Th theo hng dn ti JECFA monograph 1 - Vol.4.


20

QCVN 4-1 : 2010/BYT


- Mu th: Cn 5 g .
Ch

- Th theo hng dn ti JECFA monograph 1 - Vol.4.


- Xc nh bng k thut AAS-ICP/AES thch hp cho hm
lng quy nh. La chn c mu th v phng php
chun b mu da trn nguyn tc ca phng php m t
ti JECFA monograph 1 - Vol.4 phn Cc phng php
chung, tp cht kim loi.

6.2. nh lng
Dung dch chun
Cn 50 mg (chnh xc) chun Maltol USP, cho vo bnh
nh mc 250 ml, ha tan v nh mc n vch bng acid
hydrocloric 0,1 N v lc u. Dng pipet ly 5 ml cho vo
bnh nh mc 100 ml, pha long n vch bng acid
hydrocloric 0,1 N, lc u.
Dung dch nh lng
Cn 50 mg (chnh xc) mu th, cho vo bnh nh mc
250 ml, ha tan v nh mc n vch bng acid
hydrocloric 0,1 N v lc u. Dng pipet ly 5 ml cho vo
bnh nh mc 100 ml, pha long n vch bng acid
hydrocloric 0,1 N, lc u.
Tin hnh th
Xc nh hp th quang ca dung dch chun v dung
dch nh lng ti 274 nm s dng cuvet o 1 cm bng
thch anh, acid hydrocloric 0,1 N l mu trng.
Tnh hm lng % ca maltol trong mu th theo cng
thc sau:
% Maltol = 100 x W S x AA / (AS x WA)
Trong :
AA l hp th quang ca dung dch mu (dung dch nh
lng)
AS l hp th quang ca dung dch chun
WA l khi lng mu trong dung dch nh lng (mg)
WS l khi lng chun trong dung dch chun (mg)

21

QCVN 4-1 : 2010/BYT


Ph lc 8
YU CU K THUT V PHNG PHP TH I VI ETHYL MALTOL
1. Tn khc, ch s
2. nh ngha

INS 637
ADI = 0 - 2 mg/kg th trng
Ethyl maltol thu c bng cch tng hp ha hc

Tn ha hc

2-Ethyl-3-hydroxy-4-pyron

M s C.A.S.

4940-11-8

Cng thc ha hc

C7H8O3

Cng thc cu to

Khi lng phn t

140,14

3. Cm quan

Bt tinh th trng c mi ko bng.

4. Chc nng

Cht iu v, tr hng, hng liu.

5. Yu cu k thut
5.1. nh tnh
tan

t tan trong nc, tan trong ethanol v propylen glycol.

Khong nng chy

89o - 93o.

Hp th t ngoi

Ph hp th t ngoi ca dung dch mu th 10 mg/l trong


acid hydrocloric 0,1 N c 1 cc i hp th ti 276 nm.

5.2. tinh khit


Nc

Khng c qu 0,5% .

Tro sulfat

Khng c qu 0,2%.

Ch

Khng c qu 1,0 mg/kg.

5.3. Hm lng C7H8O3

Khng thp hn 99,0% tnh theo ch phm khan.

6. Phng php th
6.1 tinh khit
Nc

- Th theo hng dn ti JECFA monograph 1 - Vol.4


- Phng php Karl Fischer

Tro sulfat

- Th theo hng dn ti JECFA monograph 1 - Vol.4


22

QCVN 4-1 : 2010/BYT


- Cn 5 g mu
Ch

- Th theo hng dn ti JECFA monograph 1 - Vol.4.


- Xc nh bng k thut AAS-ICP/AES thch hp cho hm
lng quy nh. La chn c mu th v phng php
chun b mu da trn nguyn tc ca phng php m t
ti JECFA monograph 1 - Vol.4 phn Cc phng php
chung, tp cht kim loi.

6.2. nh lng
Dung dch chun
Cn 50 mg (chnh xc) chun Ethyl maltol USP, cho vo
bnh nh mc 250 ml, ha tan v pha long n vch bng
acid hydrocloric 0,1 N v lc u. Dng pipet ly 5 ml cho
vo bnh nh mc 100 ml, pha long n vch bng acid
hydrocloric 0,1 N, lc u.
Dung dch mu th
Cn 50 mg (chnh xc) mu th, cho vo bnh nh mc
250 ml, ha tan v pha long n vch bng acid
hydrocloric 0,1 N v lc u. Dng pipet ly 5 ml cho vo
bnh nh mc 100 ml, pha long n vch bng acid
hydrocloric 0,1 N, lc u.
Tin hnh th
Xc nh hp th quang ca dung dch chun v dung
dch mu th ti 276 nm s dng cuvet o 1-cm bng
thch anh, acid hydrocloric 0,1 N l mu trng.
Tnh hm lng % ca Ethyl maltol trong mu th theo
cng thc sau:
% Ethyl maltol = 100 x W S x AA / (AS x W A)
Trong :
AA l hp th quang ca dung dch mu th
AS l hp th quang ca dung dch chun
WA l khi lng mu trong dung dch nh lng (mg)
WS l khi lng chun trong dung dch chun (mg)

23

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