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GB 1886.47-2016 English PDF

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GB 1886.47-2016: [Including 2021XG1] National Food Safety Standard -- Food Additives -- Aspartyl Phenylalanine Methyl Ester (also known as aspartame)
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GB 1886.47-2016English159 Add to Cart 3 days [Need to translate] [Including 2021XG1] National Food Safety Standard -- Food Additives -- Aspartyl Phenylalanine Methyl Ester (also known as aspartame) Valid GB 1886.47-2016

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Basic data

Standard ID GB 1886.47-2016 (GB1886.47-2016)
Description (Translated English) [Including 2021XG1] National Food Safety Standard -- Food Additives -- Aspartyl Phenylalanine Methyl Ester (also known as aspartame)
Sector / Industry National Standard
Classification of Chinese Standard X42
Word Count Estimation 8,827
Date of Issue 2016-08-31
Date of Implementation 2017-01-01
Older Standard (superseded by this standard) GB 22367-2008
Regulation (derived from) State Health and Family Planning Commission Notice No. 11 of 2016
Issuing agency(ies) National Health and Family Planning Commission of the People's Republic of China, State Food and Drug Administration

GB 1886.47-2016: [Including 2021XG1] National Food Safety Standard -- Food Additives -- Aspartyl Phenylalanine Methyl Ester (also known as aspartame)


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(Food safety national standard - Food additive - Aspartame (also known as aspartame)) National Standards of People's Republic of China National Food Safety Standard Food additives aspartyl phenylalanine methyl ester (Also Mingasiba sweet) Issued on. 2016-08-31 2017-01-01 implementation People's Republic of China National Health and Family Planning Commission released

Foreword

This standard replaces GB 22367-2008 "Food Additives aspartic acid phenylalanine methyl ester (aspartame)." This standard compared with GB 22367-2008, the main changes are as follows. --- Standard name was changed to "national food safety standards for food additives aspartic acid phenylalanine methyl ester (also Mingasiba sweet)". National Food Safety Standard Food additives aspartyl phenylalanine methyl ester (Also Mingasiba sweet)

1 Scope

This standard applies to the L- phenylalanine, L- aspartic acid prepared by the reaction of a food additive aspartyl-phenylalanine methyl ester (also known as aspartame). 2 chemical name, molecular formula, molecular mass and structural formula 2.1 Chemical Name -L- Aspartyl L- phenylalanine methyl ester Formula 2.2 C14H18N2O5 2.3 formula 2.4 relative molecular mass 294.31 (according to 2007 international relative atomic mass)

3 Technical requirements

3.1 Sensory requirements Sensory requirements shall comply with the requirements of Table 1. Table 1 Sensory requirements Project requires test methods Color White Status crystalline granules or powder Take the right amount of sample is placed in a clean, dry white porcelain dish, self Observe the color and state of natural light 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 Aspartic acid phenylalanine methyl ester content (dry basis), w /% 98.0 ~ 102.0 Appendix A A.3 20D 14.5 ° ~ 16.5 ° Appendix Specific rotation [α] A in A.4 Transmittance ≥ 0.95 Appendix A A.5 pH 4.5 ~ 6.0 in Appendix A A.6 Loss on drying, w /% ≤ 4.5 GB 5009.3a Residue on ignition, w /% ≤ 0.2 GB 5009.4 Lead (Pb)/(mg/kg) ≤ 1.0 GB 5009.75 5-benzyl-3,6-dioxo-2-piperazin-acetic acid (BDPA) mass fraction, w /% ≤ 1.5 A.7 Appendix A Other related mass fraction, w /% ≤ 2.0 Appendix A A.8 a drying temperature of 105 ℃ ± 2 ℃, drying time of 4h.

Appendix A

Testing method A.1 General Provisions This standard reagents and water in the absence of other specified requirements, refer to the three water analytical reagent and GB/T 6682 regulations. test Used in the standard solution, standard solution for measuring impurities, formulations and products, did not indicate when the other requirements according to GB/T 601, GB/T 602, GB/T 603 provisions of preparation. Solution was used in the tests did not indicate what is formulated with solvent, it refers to an aqueous solution. A.2 Identification Test A.2.1 Identification 1 Take 2G (hydrated) ninhydrin dissolved in dimethylsulfoxide 75mL, plus 62mg ninhydrin reduction with 4mol/L lithium acetate buffer solution (PH9) was diluted to 100mL, and filtered. 10mg transferred to a test tube samples, plus 2mL reagent solution, heating, appear dark purple. A.2.2 Identification 2 Weigh about 20mg sample was dissolved in 1mL methanol, add 0.5mL methanol saturated with hydrochloride, mixing after adding 0.3mL 5mol solution of hydrogen/L of potassium hydroxide in methanol. Boil After cooling, a hydrochloric acid solution to adjust pH to 1.5, add 0.1mL ferric chloride solution, It appears reddish brown. A.2.3 solubility Slightly soluble in water and ethanol. A.3 Determination of aspartic acid phenylalanine methyl ester content (dry basis) of A.3.1 Method summary In glacial acetic acid as solvent, crystal violet as indicator, with a standard solution of perchloric acid in glacial acetic acid solution in the sample were non-aqueous titration. A.3.2 Reagents and materials A.3.2.1 glacial acetic acid. A.3.2.2 perchloric acid standard solution. c (HClO4) = 0.1mol/L. A.3.2.3 crystal violet indicator. 2g/L. A.3.2.4 acid. 98% (excellent pure). A.3.3 Analysis step Weigh about 0.3g sample (accurate to 0.0001g), in a dry 150mL iodometric flask, 1.5mL98% formic acid and 60mL glacial acetic acid, fully dissolved (operating in a fume hood), add 2 drops to 3 drops of crystal violet indicator immediately with 0.1mol/L perchlorate standard Quasi titration titration solution, when the solution go from dark green light green slightly yellowish shall end. While doing the blank test. NOTE. Use 0.1mol/L perchlorate standard solution to an endpoint titration, blank titration exceeds 0.1mL may be due to too much water and lead to the end with the naked eye View Less than observed; perchloric acid should be operated in a fume hood. A.3.4 Calculation Results Aspartic acid phenylalanine methyl ester content (dry basis) of the mass fraction w1, according to equation (A.1) Calculated. w1 = (V1-V2) × 0.02943 m0 × (1-w0) × 100% (A.1) Where. V1 --- perchlorate standard solution sample consumption volume in milliliters (mL); V2 --- blank test consumption volume perchloric acid standard solution, in milliliters (mL); 0.02943 --- consumption per 1mL concentration of 0.1mol/L standard solution of perchloric acid equivalent aspartyl benzenepropanoic in grams Quality methyl ester (aspartame) (C14H18N2O5); and m0 --- saying that the quality of the sample taken, in grams (g); w0 --- Loss on drying of the sample mass fraction,%. The difference between the two parallel determination results is not more than 0.2%, the arithmetic average of the two measurements results of the measurement results. A.4 Determination of specific optical rotation [α] 20D of Weigh about 4g sample (accurate to 0.0001g), the sample was dissolved in a sufficient amount of 15mol/L formic acid, and set the volume to 100mL, spare. in Constant temperature within 30min to 20 ℃, was measured with a polarimeter. Specific operation method according to GB/T 613 predetermined measurement results in terms of calculation To a dry basis. A.5 Determination of light transmittance A.5.1 Method summary Sample solution has maximum transmittance at 430nm wavelength. A.5.2 Instruments and Equipment A.5.2.1 Spectrophotometer. A.5.2.2 flask, pipette. A.5.3 Analysis step Weigh 0.5g sample was dissolved in hydrochloric acid solution 2mol L/and set the volume to 50mL, shake. With a 1cm cuvette at wavelength of 430nm Measured at a transmittance. With 2mol L hydrochloric acid solution/as control. The measurement results to one decimal place. A.6 pH measurement of Weigh the sample 0.80g, dissolved in water and dilute to 100mL, measured with pH meter pH of the solution. Determination A.7 5- benzyl-3,6 piperazinone acetic acid (BDPA) mass fraction A.7.1 Method summary Sample methanol solution [methanol. water = 1.9 (volume ratio)] was dissolved, equipped with a UV detector HPLC, external calibration Method. A.7.2 Reagents and materials A.7.2.1 United States Pharmacopeia (USP) standards impurities 5-benzyl-3,6-dioxo-2-piperazin-acetic acid. A.7.2.2 potassium dihydrogen phosphate. A.7.2.3 Methanol. chromatographically pure. A.7.2.4 dilute solution.200mL and 1800mL methanol and water mixing system. A.7.3 Instruments and Equipment High performance liquid chromatograph. equipped with UV detector. A.7.4 Chromatographic conditions A.7.4.1 Column. octadecyl column filled with silica gel column 250mm × 4.6mm. A.7.4.2 Mobile phase. Weigh 5.6g potassium dihydrogen phosphate to 1000mL volumetric flask, add 820mL water dissolved with phosphoric acid to adjust pH To 4.3, add 180mL of methanol, mix, dried 0.45μm filter membrane degassing. A.7.4.3 mobile phase flow rate. 2mL/min. A.7.4.4 detection wavelength. 210nm. A.7.4.5 Injection volume. 20μL. A.7.4.6 Column temperature. 40 ℃. A.7.4.7 System suitability. relative standard error of triplicate injection area response of the standard solution was not more than 2.0%. A.7.5 Analysis step A.7.5.1 5--benzyl-3,6-dioxo-2-piperazin-acetic acid (BDPA) Preparation of standard solution Weigh accurately 25mgUSP standard impurities 5-benzyl-3,6-dioxo-2-piperazin-acetic acid, placed in 100mL volumetric flask, add 10mL dissolved in methanol, diluted with water to volume, and mix. The solution was to draw 15mL to 50mL volumetric flask, diluted solution (A.7.2.4) Dilute to the mark, and mix with a 0.45μm microporous membrane filtration. The solution should be now with the current. A.7.5.2 Preparation of sample solution Weigh accurately 50mg sample, placed in 10mL volumetric flask, diluted with dilute solution (A.7.2.4) to volume, and mix with 0.45μm microporous membrane filtration. The solution should be using now. A.7.5.3 5--benzyl-3,6-dioxo-2-piperazin-acetic acid (BDPA) Determination They were injected by A.7.5.1 and BDPA standard solution and the sample solution each 20μL A.7.5.2 prepared, record the chromatograms and chromatograms The 5-benzyl-3,6-dioxo-2-piperazin acid peak area response. 5-benzyl-3,6-dioxo-2-piperazin retention time is about 4min acid; Aspartic acid phenylalanine methyl ester (aspartame) retention time is about 11min. A.7.6 5- result-benzyl-3,6-dioxo-2-piperazin-acetic acid (BDPA) mass fraction calculation 5-benzyl-3,6-dioxo-2-piperazin-quality acetic acid (BDPA) fraction w2, according to equation (A.2) Calculated. w2 = AU × cS AS × mU × 1000 (A.2) Where. AU --- 5--benzyl-3,6-dioxo-2-piperazin-acetic acid in the sample area in response; CS --- 5- benzyl-3,6-dioxo-2-piperazin-acetic acid concentration in the standard solution, in milligrams per milliliter (mg/mL); AS --- 5- benzyl-3,6-dioxo-2-piperazin-acetic acid in the standard area of response; MU --- the quality of the sample, in milligrams (mg); 1000 --- conversion factor. A.8 Determination of mass fraction of other relevant A.8.1 Preparation of other relevant material standard solution Extracted for 5-benzyl-3,6-dioxo-2-piperazin test solution of acetic acid to the content of the detected 2mL 100mL volumetric flask, diluted solution Solution (A.7.2.4) diluted to volume, and mix. A.8.2 Determination and judgment Were injected into other relevant material standard solution and sample solution each 20μL, record the chromatogram for 2 times the aspartic acid phenylalanine methyl Ester (aspartame) retention time. 5-benzyl-3,6-dioxo removed piperazinone acid peak area response of the sample solution in the other area response Is not greater than the sum of other aspartic acid phenylalanine methyl ester was associated standard solution obtained (aspartame) peak area response value.

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