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GB 1886.353-2021: National Food Safety Standard - Food Additive - ??-cyclodextrin
GB 1886.353-2021
GB
NATIONAL STANDARD OF THE
PEOPLE?€?S REPUBLIC OF CHINA
National Food Safety Standard - Food Additive -
??-cyclodextrin
ISSUED ON: SEPTEMBER 07, 2021
IMPLEMENTED ON: MARCH 07, 2022
Issued by: National Health Commission of the People's Republic of
China;
State Administration for Market Regulation.
Table of Contents
1 Scope ... 3??
2 Molecular formula and relative molecular mass ... 3??
3 Technical requirements ... 3??
Appendix A Inspection method ... 5??
National Food Safety Standard - Food Additive - ??-
cyclodextrin
1 Scope
This Standard applies to the food additive ??-cyclodextrin that is prepared by
enzymatic hydrolysis and extraction of starch.
2 Molecular formula and relative molecular mass
2.1 Molecular formula
(C6H10O5)8
2.2 Relative molecular mass
1297.13 (according to the international relative atomic mass in 2018)
3 Technical requirements
3.1 Sensory requirements
Sensory requirements shall meet the requirements of Table 1.
3.2 Physical and chemical indicators
Physical and chemical indicators shall meet the requirements of Table 2.
Appendix A??
Inspection method
A.1 General provisions
The reagents and water used in this Standard refer to analytical reagents and
grade-3 water in accordance with GB/T 6682, when other requirements are not
indicated. The standard solutions used in the test, the standard solutions for
impurity determination, the preparations and products, unless otherwise
specified, shall be prepared in accordance with GB/T 601, GB/T 602 and GB/T
603. The solution used in the test refers to an aqueous solution, when it is not
specified which solvent is used to prepare it.
A.2 Identification test
A.2.1 Specific rotation test
Weigh 1.00 g of the sample and dissolve it in 100 mL of water; measure it
according to the method that is specified in GB/T 613. The specific rotation shall
be +173?? ~ +180??.
A.2.2 Chromatographic test
In the ??-cyclodextrin content determination test, the retention time of the main
peak of the test solution chromatogram shall be consistent with the retention
time of the main peak of the standard solution chromatogram.
A.3 Determination of ??-cyclodextrin content (on a dry basis)
A.3.1 Reagents and materials
A.3.1.1 Methanol: chromatographically pure.
A.3.1.2 Water: Grade-1 water specified in GB/T 6682.
A.3.1.3 ??-cyclodextrin standard substance: purity ???98.0%.
A.3.2 Instruments and equipment
High performance liquid chromatograph: equipped with a refractive index
detector.
A.3.3 Reference chromatographic conditions
A.3.3.1 Chromatographic column: C18, C8, phenyl column or other reverse
chromatographic columns (5 ??m, 150 mm ?? 4.6 mm).
A.3.3.2 Mobile phase: water: methanol = 93: 7, if necessary, it can be adjusted.
A.3.3.3 Column temperature: 30 ??C.
A.3.3.4 Detector temperature: 40 ??C.
A.3.3.5 Flow rate: 1.0 mL/min.
A.3.3.6 Injection volume: 20 ??L.
A.3.4 Analysis steps
A.3.4.1 Preparation of standard solution
Accurately weigh an appropriate amount of ??-cyclodextrin standard product (on
a dry basis, refer to Method 1 in GB 5009.3-2016 for the drying method); add
water to dissolve; dilute to a standard solution of a concentration of about 1.0
mg/mL (on a dry basis). Use a 0.45 ??m microporous membrane for filtration
before chromatographic analysis.
A.3.4.2 Preparation of analytical stock solution
Accurately weigh 250 mg of the sample (on a dry basis, refer to Method 1 in
GB 5009.3-2016 for the drying method); put it in a 25 mL measuring flask; add
water to dissolve it; take it out; let it cool; use water to dilute to the mark.
A.3.4.3 Preparation of analytical solution
Precisely pipette 5.0 mL of analytical stock solution; place it in a 50.0 mL
measuring flask; use water to dilute to the mark.
A.3.4.4 Preparation of system suitability solution
Accurately weigh an appropriate amount of ??-cyclodextrin standard substance
(on a dry basis, refer to Method 1 in GB 5009.3-2016 for the drying method);
add water to dissolve; obtain a ??-cyclodextrin solution of a concentration of
about 0.5 mg/mL.
A.3.4.5 System suitability test
Under the reference chromatographic conditions of A.3.3, respectively
determine the standard solution and sample solution. The system suitability
means that, for 5 repeated injections of the standard solution, the relative
standard deviation of the response area obtained is less than 2.0%.