GB 1886.353-2021National Food Safety Standard - Food Additive - gamma-cyclodextrin (English PDF)

2.1 Molecular formula

(C6H10O5)8

2.2 Relative molecular mass

1297.13 (according to the international relative atomic mass in 2018)

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.

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 gamma-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 gamma-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 gamma-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 µm, 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 µL

A.3.4 Analysis steps

A.3.4.1 Preparation of standard solution

Accurately weigh an appropriate amount of gamma-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 µm 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 gamma-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 gamma-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%. […]