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GB 1886.69-2016 English PDF

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GB 1886.69-2016: [Including 2020XG1] National Food Safety Standard -- Food Additives -- Asparagine phenylalanine methyl ester Acesulfame acid
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GB 1886.69-2016English239 Add to Cart 3 days [Need to translate] [Including 2020XG1] National Food Safety Standard -- Food Additives -- Asparagine phenylalanine methyl ester Acesulfame acid Valid GB 1886.69-2016

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Basic data

Standard ID GB 1886.69-2016 (GB1886.69-2016)
Description (Translated English) [Including 2020XG1] National Food Safety Standard -- Food Additives -- Asparagine phenylalanine methyl ester Acesulfame acid
Sector / Industry National Standard
Classification of Chinese Standard X40
Word Count Estimation 12,140
Date of Issue 2016-08-31
Date of Implementation 2017-01-01
Regulation (derived from) Announcement of the State Administration of Public Health and Family Planning 2016 No.11
Issuing agency(ies) National Health and Family Planning Commission of the People's Republic of China, State Food and Drug Administration

GB 1886.69-2016: [Including 2020XG1] National Food Safety Standard -- Food Additives -- Asparagine phenylalanine methyl ester Acesulfame acid


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(Food safety national standard - Food additive - Aspartyl phenylalanine methyl ester Acesulfameic acid) National Standards of People's Republic of China National Food Safety Standard Food additives aspartyl phenylalanine methyl ester Acesulfame Published 2016-08-31 2017-01-01 implementation People's Republic of China National Health and Family Planning Commission issued National Food Safety Standard Food additives aspartyl phenylalanine methyl ester Acesulfame

1 Scope

This standard applies to aspartyl phenylalanine methyl ester and acesulfame salts as raw materials, the reaction, centrifugation, drying and other processing steps made The obtained food additive aspartyl phenylalanine methyl ester acesulfame. 2 Chemical name, molecular formula, structural formula and relative molecular mass 2.1 Chemical Name [2-carboxy -β- (N- (b- methoxycarbonyl-2-phenyl) ethylcarbamoyl)] ethanamine positive ion methyl-4-oxo-1,2,3 thiazin-3-negative 2,2-dioxide was ionized Formula 2.2 C18H23O9N3S 2.3 formula 2.4 Molecular Weight 457.46 (according to 2007 international relative atomic mass)

3 Technical requirements

3.1 Sensory requirements Sensory requirements shall comply with the requirements in Table 1. Table 1 Sensory requirements Project requires test methods Color White State crystalline powder Odor odorless Proper amount of sample is placed in a clean, dry glass dish, from the Under natural light, the color observed and the state, sniffing the odor 3.2 Physical and Chemical Indicators Physical and chemical indicators should be consistent with the provisions of Table 2. Table 2. Physical and chemical indicators Item Index Test Method Content (dry basis), w /% Acesulfame Aspartyl phenylalanine methyl ester 34.0 to 37.0 63.0 - 66.0 Appendix A A.4 Loss on drying, w /% ≤ 0.5 GB 5009.3 a direct drying method Specific rotation αm (20 ℃, D) 14.5 ~ 16.5 A.5 Appendix A Potassium, w /% ≤ 0.5 A.6 Appendix A 5-benzyl-3,6-dioxo-2-piperazin-acetic acid, w /% ≤ 0.5 Appendix A A.7 Other related substances, w /% ≤ 1.0 Appendix A A.7 Lead (Pb)/(mg/kg) ≤ 1.0 GB 5009.12 a drying temperature of 105 ℃, drying time was 4h.

Appendix A

Testing method A.1 Warning Some test procedure specified test methods can lead to dangerous situations, the operator should take appropriate safety and health practices. A.2 General Provisions As used in this standard reagents and water, in the absence of other requirements specified, refer to two predetermined analytical grade water and GB/T 6682 in. Standard Solution used in the test, the determination of impurities standard solutions, products and preparations, in the absence of other requirements specified, are by GB/T 601, a predetermined preparation GB/T 602 and GB/T 603 a. Was used in the test does not indicate when formulated with solvents which are meant water Solution. A.3 Identification Test The maximum number of samples in the wave KBr dispersants, presented in the infrared absorption spectrum and aspartyl-phenylalanine methyl ester acesulfame The same standard, the standard infrared spectra Figure A.1. Figure A.1 aspartyl phenylalanine methyl ester acesulfame standard infrared spectra A.4 Determination of content (dry basis) of A.4.1 Titration A.4.1.1 Reagents and materials A.4.1.1.1 benzoic acid. purity ≥99%. A.4.1.1.2 ethanol. A.4.1.1.3 N, N- dimethylformamide. A.4.1.1.4 Thymol Blue solution in methanol. Weigh 0.30g thymol blue in a beaker, dissolved in methanol and diluted to 100mL. A.4.1.1.5 tetrabutyl ammonium hydroxide in methanol solution. 0.1mol/L. Calibration tetrabutylammonium hydroxide methanol solution (0.1mol/L). the amount of 10 ml of N, N-dimethylformamide in a conical flask, 0.05mL Thymol Blue solution in methanol, with 0.1mol/L tetrabutyl ammonium hydroxide in methanol solution was titrated until a pure blue color produced. Join Now 0.2g (accurate to 0.001 g of) benzoic acid, stirring the blue color disappeared, dropwise with 0.1mol/L tetrabutyl ammonium hydroxide in methanol under nitrogen Generated until the predetermined pure blue. Recording the second titration fluid volume (V) consumed by titration. Tetrabutyl ammonium hydroxide methanol solution concentration c1, in moles per liter (mol/L) basis, calculated according to formula (A.1). c1 = m × 1000 Vl --- sample as tetrabutylammonium consumption of the first jump point volume ammonium hydroxide in methanol solution, in milliliters (mL); C1 --- tetrabutylammonium hydroxide methanol solution concentration, expressed in moles per liter (mol/L); --- M2 molar mass of acesulfame, in units of grams per mole (g/mol), [M2 (C4H5NO4S) = 163.15]; M1 --- mass of sample, grams (G); 1000 --- conversion factor. Mass fraction aspartyl-phenylalanine methyl ester w2, calculated according to formula (A.3). w2 = (V2-V1-V0) × c1 × M3 m1 × 1000 × 100% (A.3) Where. --- Sample V2 consumed as tetrabutylammonium second jump point of the volume of ammonium hydroxide methanol solution, in milliliters (mL); Vl --- sample as tetrabutylammonium consumption of the first jump point volume ammonium hydroxide in methanol solution, in milliliters (mL); V0 --- Blank as tetrabutyl ammonium hydroxide solution in methanol consumption volume in milliliters (mL); C1 --- tetrabutylammonium hydroxide methanol solution concentration, expressed in moles per liter (mol/L); --- M3 molar mass of aspartic acid-phenylalanine methyl ester, in units of grams per mole (g/mol), [M3 (C14H18N2O5) = 294.31]; M1 --- mass of sample, grams (G); 1000 --- conversion factor. A.4.2 HPLC Weigh about 0.1g sample, to the nearest 0.001g. A 100mL beaker with a small amount of methanol was dissolved. Into 100mL capacity Volumetric flask, dilute to volume with methanol, shake. The precise amount of 1.0mL of the solution, methanol solution was brought to 10mL, for liquid Chromatograph, the sample solution is measured for an existing service. Chromatographic conditions A.4.2.3.3 Reference Column. C18 column, 250mm × 4.6mm, 5μm, or equivalent column separation effect. Mobile phase. potassium phosphate solution. Detection wavelength. 210nm. Column temperature. 40 ℃. Flow rate. 2.0mL/min A.4.2.3.4 Determination Pipette mixed standard solution and sample solution of each series of 10μL were determined by liquid chromatography, the sample is calculated according to the standard curve Content of acesulfame and aspartyl-phenylalanine methyl ester. Acesulfame and aspartyl-phenylalanine methyl ester mixed standard solution Liquid chromatography is shown in Figure A.2, liquid chromatogram of the sample solution aspartyl phenylalanine methyl ester acesulfame Figure A.3. Description. 1 --- acesulfame; 2 --- aspartyl phenylalanine methyl ester. Figure A.2 acesulfame and aspartyl-phenylalanine methyl ester mixture of the liquid chromatograph of the standard solution Description. 1 --- acesulfame; 2 --- aspartyl phenylalanine methyl ester. Figure A.3 days liquid chromatography sample solution FIG alanine aspartic acid phenylmethyl ester acesulfame A.4.2.4 calculation results The mass fraction of the sample or acesulfame aspartyl-phenylalanine methyl ester w3, calculated according to formula (A.4). w3 = c2 × V3 × f m2 × 1000 × 1000 × 100% (A.4) Where. --- C2 concentration from the standard curve obtained acesulfame or aspartyl-phenylalanine methyl ester, in units of milligrams per Liter (mg/L); V3 --- constant volume of the sample solution, in milliliters (mL); f --- dilution of the sample solution; --- M2 mass of sample, grams (G); 1000 --- conversion factor. In parallel arithmetic mean of test results of measurement results prevail, the result rounded to three significant figures. Obtained under repeatability conditions two The ratio of the arithmetic mean of the absolute difference and independent measurement result is not more than 5.0%. Specific rotation was measured A.5 αm (20 ℃, D) of A.5.1 Reagents and materials Formic acid solution. 15mol/L. A.5.2 Instruments and Equipment Polarimeter. A.5.3 Analysis step 6.200g weighed sample dissolved in formic acid and dilute to 100mL. Temperature within 30min to 20 ℃, according to GB/T 613 Regulations Given method was measured by a polarimeter to obtain rotation aspartyl phenylalanine methyl ester ratio. A.5.4 calculation results Sample transit aspartic acid-phenylalanine methyl ester acesulfame specific rotation αm (20 ℃, D), according to formula (A.5) Calculated. αm (20 ℃, D) = α1 0.646 (A.5) Where. alpha] l --- rotation ratio measured aspartyl phenylalanine methyl ester in the sample; 0.646 --- aspartyl phenylalanine methyl ester conversion Narita aspartic acid-phenylalanine methyl ester coefficient acesulfame. Determination of potassium A.6 A.6.1 Reagents and materials A.6.1.1 KCl. standard substance, and dried before use at 105 ℃ 2h. A.6.1.2 hydrochloride. excellent pure. Sodium chloride solution A.6.1.3.200g/L. A.6.2 Instruments and Equipment Atomic absorption spectrometer. A.6.3 Analysis step Preparation of standard solution A.6.3.1 A.6.3.1.1 potassium standard stock solution. 100mg/L, accurately weighed 0.1907g of potassium chloride, was dissolved in water and 1000mL volumetric flask, and dilute Diluted to volume, and mix. A.6.3.1.2 Standard Potassium solution. 10.0mg/L, potassium taken 10.00mL standard stock solution to 100mL volumetric flask, dilute to the mark with water, Mix well. Standard solutions of potassium A.6.3.1.3 series. were taken 2.50mL, 5.00mL, 10.0mL, 15.0mL, 20.0mL standard solution of potassium (A.6.3.1.2) to a 100mL volumetric flask, add 2.0mL sodium chloride solution, 1.0 mL of hydrochloric acid, then dilute to the mark with water. That was a bit strong Having a degree of 0.25mg/L, 0.5mg/L, 1.0mg/L, 1.5mg/L, 2.0mg/L potassium standard solution series. Preparation of sample solution A.6.3.2 Weigh about 3g samples, accurate 0.001g. Placed in a beaker, dissolved in water, transferred to a 500mL volumetric flask, dilute to the mark. Pipette 10.00mL sample solution to 100mL volumetric flask, was added 2.0 mL sodium chloride solution, 1.0mL dilute hydrochloric acid, water to volume, and mix. A.6.3.3 Determination With the use of potassium hollow cathode lamp and an air-acetylene flame atomic absorption spectrometry, emission line at 766.5nm potassium, adjusting instrument Determination of optimal conditions, standard series, respectively, and the blank solution and the sample solution was measured absorption values. With absorbance values of standard solutions and the concentration of potassium Draw standard curve. A.6.4 calculation results Mass fraction potassium w4, calculated according to formula (A.6). w4 = (C3-c0) × V4 × f m3 × 1000 × 1000 × 100% (A.6) Where. C3 --- measurement of potassium concentration in the sample solution, in milligrams per liter (mg/L); cO --- blank solution measured by the concentration of potassium in milligrams per liter (mg/L); --- V4 constant volume of the sample in milliliters (mL); f --- dilution of the sample solution; --- mass M3 of the sample in grams (G); 1000 --- conversion factor. In parallel arithmetic mean of test results of measurement results prevail, the results two significant figures. Obtained under repeatability conditions two The ratio of the arithmetic mean of the absolute difference and independent measurement result is not greater than 10%. Determination piperazine acetic acid and other substances A.7 5- benzyl-3,6-dioxo -2- A.7.1 Reagents and materials A.7.1.1 5- benzyl-3,6-dioxo-2-piperazin-acetic acid. 99.5% purity. A.7.1.2 Methanol. HPLC grade. A.7.1.3 potassium phosphate solution. Weigh 5.6g of potassium phosphate, was added 820mL of water, adjusted with phosphoric acid pH = 4.3, was added 180mL of methanol, mixed Uniform, through 0.45μm filter, degassed standby. A.7.1.4 methanol. 19. A.7.2 Instruments and Equipment HPLC. equipped with a UV detector. A.7.3 Analysis step Preparation of standard solution A.7.3.1 A.7.3.1.1 5- benzyl-3,6-dioxo-2-piperazin acid standard solution. 0.25mg/mL, accurately weighed 0.025g5- -2- benzyl-3,6-dioxo Piperazine acetic acid, was added 10mL of methanol, diluted with water to 100mL. A.7.3.1.2 5- benzyl-3,6-dioxo-2-piperazin acid Using the standard solution. 0.075mg/mL, suction 0.25mg/mL5- benzyl-3,6-bis Oxo-2-piperazine acetic acid standard 15mL, 50mL volumetric flask, diluted to the mark with methanol and mix standby. A.7.3.1.3 other related substance standard solution. Take the sample solution A.7.3.2 1.5mL, diluted with methanol to a 100mL volumetric flask To volume, and mix. A.7.3.2 Preparation of sample Weigh about 0.05g sample, accurate to 0.0001g, was dissolved in methanol, transferred to a 10mL volumetric flask, dilute to volume, active Existing service. Chromatographic conditions A.7.3.3 Reference Column. C18 column, 250mm × 4.6mm, 5μm, or equivalent column separation effect. Mobile phase. potassium phosphate solution. Detection wavelength. 210nm. Column temperature. 40 ℃. Flow rate. 2.0mL/min. A.7.3.4 Determination 5-benzyl-3,6-dioxo suction 2-piperazin acid standard solutions, standard solutions and other substances in each sample solution was subjected to liquid 20μL Chromatographic analysis, and other related materials were recorded standard solution and sample solution transit aspartic acid-phenylalanine methyl ester peak time twice the color Spectrum (about 30min). FIG LC-3,6-dioxo-5-benzyl-2-piperazin acid standard solution is shown in Figure A.4. FIG A.4 5- benzyl-3,6-dioxo-2-piperazin acetate FIG HPLC standard solution A.7.4 calculation results Sample 5-benzyl-3,6-dioxo-2-piperazin-acetate mass fraction w5, according to equation (A.7) calculated. w5 = A1 × c4 × V5 A × m4 × 1000 × 100% (A.7) Where. A1 --- measurement sample peak area of solution of 5-benzyl-3,6-dioxo-2-piperazin-acetic acid; c4 --- 5- benzyl-3,6-dioxo-2-piperazin acid concentration standard solution, in milligrams per milliliter (mg/mL); --- V5 constant volume of the sample in milliliters (mL); A --- 5- benzyl-3,6-dioxo-2-piperazin peak area of the standard solution of acetic acid; --- M4 mass of the sample in grams (G); 1000 --- conversion factor. The mass fraction of the sample-related substances w6, calculated according to formula (A.8). w6 = A2 A3 × 100% (A.8) Where. A2 --- measurement sample solution, in addition to 5-benzyl-3,6-dioxo-2-piperazin-acetic acid, acesulfame and aspartyl-phenylalanine methyl ester Peak area and outside the other two peaks; A3 --- Other related substance peak area of standard solution transit Asp-Phe methyl ester. In parallel arithmetic mean of test results of measurement results prevail, the results two significant figures. Obtained under repeatability conditions two The ratio of the arithmetic mean of the absolute difference and independent measurement result is not greater than 10%.

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