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GB 25531-2010: The national food safety standards of food additives sucralose
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The national food safety standards of food additives sucralose
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GB 25531-2010
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Basic data | Standard ID | GB 25531-2010 (GB25531-2010) | | Description (Translated English) | The national food safety standards of food additives sucralose | | Sector / Industry | National Standard | | Classification of Chinese Standard | X42 | | Classification of International Standard | 67.220.20 | | Word Count Estimation | 10,165 | | Date of Issue | 2010-12-21 | | Date of Implementation | 2011-02-21 | | Regulation (derived from) | Ministry of Health Bulletin No. 19 of 2010 | | Issuing agency(ies) | Ministry of Health of the People's Republic of China | | Summary | This Chinese standard applies to sugar as raw material, chlorine atoms, optionally substituted with three hydroxyl groups and prepared food additives sucralose. | GB 25531-2010: The national food safety standards of food additives sucralose---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
The national food safety standards of food additives sucralose
National Food Safety Standard
Sucralose Food Additive
Issued on. 2010-12-21
2011-02-21 implementation
National Standards of People's Republic of China
People's Republic of China Ministry of Health issued
Foreword
Appendix A of this standard is a normative appendix.
National Food Safety Standard
Sucralose Food Additive
1 Scope
This standard applies to sugar as raw material, a chlorine atom optionally substituted three hydroxyl groups prepared food additive sucralose.
2 Normative references
The standard file referenced in the application of this standard is essential. For cited documents with dates, only the date of
Version applies to this standard. For undated references, the latest edition (including any amendments) applies to this standard.
3 chemical name, molecular formula, molecular mass and structural formula
3.1 Chemical Name
1,6-dichloro-1,6-dideoxy -β-D- fructofuranosyl 4-chloro-4-deoxy-furan -α-D- galactopyranoside
Formula 3.2
C12H19Cl3O8
3.3 formula
3.4 relative molecular mass
397.63 (according to 2007 international relative atomic mass)
4. Technical Requirements
4.1 Sensory requirements. comply with Table 1.
Table 1 Sensory requirements
Project requires test methods
White to nearly white color proper amount of sample is placed in a clean, dry white porcelain dish, in
Natural light, to observe its color and texture, and olfactory
Its taste.
Odour odorless
Organizational status crystalline powder
4.2 Physical indicators. to comply with Table 2.
Table 2. Physical and chemical indicators
Item Index Test Method
Sucralose (dry basis), w /% 98.0 ~ 102.0 Appendix A A.3
Specific rotation αm (20 ℃, D)/[(º) · dm2 · kg-1] 84.0 ~ 87.5 Appendix A A.4
Water, w /% ≤ 2.0 GB/T 6283
Residue on ignition, w /% ≤ 0.7 GB/T 9741a
Hydrolyzate by examining A.5 Appendix A
Related substances by examining A.6 in Appendix A
Methanol, w /% ≤ 0.1 Appendix A A.7
Lead (Pb)/(mg/kg) ≤ 1 GB 5009.12
a sample weight of 1 g ~ 2g.
Appendix A
(Normative)
Testing method
A.1 General Provisions
Unless otherwise indicated in the analysis using only recognized as analytical reagents and GB/T 6682-2008 specified in the water. In the analysis
Standard titration solution, impurities measured by standard solution, preparations and products, did not indicate when the other requirements, according to GB/T 601, GB/T
602, the provisions of preparation GB/T 603's. This solution was used in the test does not indicate what is formulated with solvent, it refers to an aqueous solution.
A.2 Identification Test
A.2.1 detecting sucralose test, the specimen in the liquid phase chromatogram peak retention time of the standard solution should sucralose
Sugar same retention time.
A.2.2 related substances detection tests, Rf value of thin-layer chromatogram of the sample solution in the main spots should be the standard solution of the main spots with Rf value
with.
A.3 Determination of sucralose
A.3.1 Reagents and materials
a) acetonitrile. chromatography.
b) Sucralose Standard. mass fraction ≥98.0%.
A.3.2 Instruments and Equipment
High performance liquid chromatograph. equipped with a differential refractive index detector, or other equivalent detectors.
A.3.3 reference chromatographic conditions
a) Column. C18 reverse phase column, 8mm × 10cm, particle size 5μm; or other equivalent column.
b) Mobile phase. After 150mL of acetonitrile and 850mL of water were mixed uniformly, using 0.45μm membrane filter, degassed ultrasound standby.
c) Column temperature. room temperature.
d) Mobile phase flow rate. 1.5 mL/min.
e) Injection volume. 20 μL.
f) Sucralose retention time. about 9min, required to ensure the retention time, the proportion of mobile phase can be adjusted if necessary.
NOTE. System Suitability standard solution is injected twice repeated, resulting in response to the relative error is less than 2.0% area.
A.3.4 Analysis step
A.3.4.1 Preparation of standard solutions
Weigh about 0.025g sucralose standard (accurate to 0.0001g), dissolved in mobile phase and transferred to 25mL volumetric flask, add stream
Mobile phase to volume, and the resulting solution was 0.45μm membrane filter, and the filtrate set aside.
A.3.4.2 Preparation of sample solution
Weigh about 0.025g sample (accurate to 0.0001g), dissolved in mobile phase and transferred to 25mL volumetric flask, add the mobile phase to volume
Scale, the resulting solution was 0.45μm membrane filter, the filtrate was set aside.
A.3.5 Determination
In A.3.3 reference chromatographic conditions, respectively, the standard solution and the sample solution was measured injection volume of 20 μL, repeat injections once,
Calculate the peak area average.
A.3.6 Calculation Results
Sucralose content X1 according to formula (A.1) Calculated.
) 1 (0
1 × - ××
×× =
XMA
PMAX
US
sU (A.1)
Where.
Content X1-- sucralose sample,%;
AU-- liquid chromatography sample mean peak area;
MS-- weighed sucralose standard mass in grams (g);
P-- sucralose content standards in marked sucralose,%;
AS-- mean standard solution chromatogram peak area;
MU-- saying that the quality of the sample taken, in grams (g);
X0-- measured moisture content of the sample,%.
The results parallel arithmetic mean of the measurement results shall prevail. Twice in the same condition absolutely independent determination results
The difference is not more than 2% of the arithmetic mean.
A.4 Determination of specific rotation
A.4.1 Weigh about 1 g sample (accurate to 0.00 1g), dissolved in water, transferred to a 100 mL volumetric flask, add water to the mark, shake
uniform. The measurement temperature was 20 ℃ ± 0.5 ℃.
Specific rotation αm (20 ℃, D) value to (°) · dm2 · kg-1 according to formula (A.2) Calculated.
(A.2)
Where.
α - measured angle of rotation, in degrees (°);
l - the length of the optical tube unit decimeter (dm);
ρα - mass concentration in the solution effective component in grams per milliliter (g/mL).
A.4.2 Other conducted in accordance with GB/T 613-2007 in.
Determination A.5 hydrolyzate
A.5.1 Reagents and materials
a) p- anisidine.
b) phthalic acid.
c) methanol.
d) mannitol.
e) fructose.
A.5.2 Instruments and Equipment
TLC plates. silica gel coated with Merk 60 or other equivalent materials 0.25mm thickness.
()
αρ
αα
DCm = °, 20
A.5.3 Analysis step
Preparation of the toner was A.5.3.1
The 1.23g p- anisidine and 1.66 g phthalic acid dissolved in 100 mL of methanol. The solution was kept in the dark and refrigerated, if dissolved
Failure was already fading.
A.5.3.2 Preparation of standard solution A
Weigh 10g mannitol (accurate to 0.001g), dissolved in water and transferred to 100mL volumetric flask with water to volume.
A.5.3.3 Preparation of standard solution B
Weigh 10g mannitol (accurate to 0.001g) and 0.04g fructose (accurate to 0.0001g), transferred to 100mL volumetric flask
With water to volume.
A.5.3.4 Preparation of sample solution
Weigh 2.5g sample (accurate to 0.001g), was dissolved with 5mL methanol, transferred to a 10mL volumetric flask with methanol to
Scale.
A.5.4 Determination
Take standard solution A, B standard solution and the sample solution each 5μL, respectively, in different locations with a TLC plate spotting,
Each solution will be 5 times (each time 1μL) points on the board, to be spotted between each sample point and then continue drying, 3 parts of sample area
To basically the same, After spotting is finished with a chromogenic reagent spray after 100 ℃ ± 2 ℃ oven heating 15min, immediately after heating in a dark background
Observed chromatography plate, the sample solution should not be deeper than the coloring stain stain blush standard solution B.
Note. If the spotting point standard solution A blackened, indicating chromatography plate is heated for too long, it must be remade.
A.6 Determination of related substances
A.6.1 Reagents and materials
a) Sucralose Standard. mass fraction ≥98.0%.
b) acetonitrile.
c) sulfuric acid.
d) methanol.
e) NaCl. 50g/L.
A.6.2 Instruments and Equipment
TLC plate. 0.2mm thickness coated with C18 alkyl modified silica gel or other equivalent material.
A.6.3 Analysis step
A.6.3.1 Preparation Agent Expand
Developing solvent. sodium chloride solution. acetonitrile = 70.30 (ratio by volume).
Preparation of the toner was A.6.3.2
Preparation of a methanol solution of 15% sulfuric acid (volume fraction).
A.6.3.3 Preparation of standard solutions
Weigh 0.5g sucralose standard (accurate to 0.001g), was dissolved in 5.0mL of methanol, and this is the solution C. Draw 0.5mL
Solution C, with methanol to 100mL, this is the solution D.
A.6.3.4 Preparation of sample solution
Weigh 1.0g sample (accurate to 0.001g), was dissolved in 10.0mL of methanol.
A.6.4 Determination
Take the solution C, D and solution of each sample solution 5μL, point to the bottom of the TLC plate, the plate is placed chromatography developing solvent containing the chromatography tank
, The solvent front to move to be expanded after removing 15cm TLC plate placed to be the agent evaporate after use color sprays,
Then heated at 125 ± 2 ℃ ℃ oven for 10min. Rf value of the sample solution should be the primary stain solution C Rf value the same as the main spots and the specimen
Other liquid stains should be no deeper than the coloring solution D main stain coloration.
Rf value - after the sample spots to expand distance from the origin to the solvent front and the ratio of the distance from the origin.
A.7 Determination of methanol
A.7.1 Reagents and materials
a) Methanol Standard. chromatography.
b) n-propanol. chromatography.
c) pyridine. chromatography.
A.7.2 Instruments and Equipment
Gas chromatograph. with hydrogen flame ionization detector.
A.7.3 reference chromatographic conditions
a) Column. 2.1m × 4mm (inner diameter) glass column, within 0.2mm ~ 0.15mm polystyrene chromatographic stationary phase filling; or
He is equivalent to the column.
b) Carrier gas. nitrogen or helium.
c) Column temperature. 150 ℃.
d) Inlet temperature.200 ℃.
e) Detector temperature. 250 ℃.
f) flow rate. 20mL/min.
g) Injection volume. 1μL.
NOTE. System Suitability standard solution is injected twice repeated, resulting in response to the relative error is less than 2.0% area.
A.7.4 Analysis step
A.7.4.1 Preparation of internal standard solution
Imbibe 1.0mL n-propanol, placed in 100mL flask with pyridine to volume, shake. The solution was pipetted 5mL,
Placed in 500mL flask with pyridine to volume, shake.
A.7.4.2 Preparation of standard solutions
Imbibe 2.0mL methanol, placed in 100mL flask, with internal standard solution to volume, shake. Pipette 1.0mL of the solution
It was placed in 100mL flask, with internal standard solution to volume, shake.
A.7.4.3 Preparation of sample solution
Weigh about 2g sample (accurate to 0.001g), was dissolved with the internal standard solution and transferred to 10mL volumetric flask, using the internal standard solution to volume
Mark and shake.
A.7.5 Determination
In A.7.3 reference chromatographic conditions, respectively, the standard solution and the sample solution was measured injection volume was 1 μL, a repeat injection
Second, calculate the peak area ratio of methanol and the internal standard peak area of each injection.
A.7.6 Calculation Results
X2 methanol content according to formula (A.3) Calculated.
10000158.02 ××
× =
US
MR
RX% (A.3)
Where.
X2-- sample methanol content,%;
RU-- two injections of the sample solution in methanol and internal standard (n-propanol) average ratio of peak areas;
0.00158-- concentration standard solution in methanol × × bulk density of the sample solution in methanol (2 × 10-4 × 0.79 × 10);
RS-- two injections standard solution of methanol and internal standard (n-propanol) average ratio of peak areas;
MU-- saying that the quality of the sample taken, in grams (g).
The results parallel arithmetic mean of the measurement results shall prevail. Twice in the same condition absolutely independent determination results
The difference is not more than 10% of the arithmetic mean.
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