GB 22367-2008 English PDF

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GB 22367-2008: Food additive -- N-L-α-Aspartyl-L-phenylalanine-L-methyl ester (Aspartame)
Status: Obsolete

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB 22367-2008	439	Add to Cart	3 days	Food additive -- N-L-α-Aspartyl-L-phenylalanine-L-methyl ester (Aspartame)	Obsolete

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Basic data

Standard ID: GB 22367-2008 (GB22367-2008)
Description (Translated English): Food additive -- N-L-��-Aspartyl-L-phenylalanine-L-methyl ester (Aspartame)
Sector / Industry: National Standard
Classification of Chinese Standard: X42
Classification of International Standard: 67.220.20
Word Count Estimation: 11,112
Date of Issue: 2008-09-10
Date of Implementation: 2009-03-01
Quoted Standard: GB/T 601; GB/T 602; GB/T 603; GB/T 613; GB/T 5009.3; GB/T 5009.4; GB/T 5009.75; GB/T 6682
Regulation (derived from): Announcement of Newly Approved National Standards No. 16 of 2008 (No. 129 overall)
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary: This Chinese standard specifies the food additive aspartic acid phenylalanine methyl ester (aspartame) technical requirements, test methods, inspection rules and signs, packaging, transport and storage. This standard applies to the L-phenylalanine, L- aspartic acid and other food additives, prepared by the reaction of aspartic acid phenylalanine methyl ester (aspartame).

GB 22367-2008: Food additive -- N-L-α-Aspartyl-L-phenylalanine-L-methyl ester (Aspartame)

---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.
Food additive.NL-α-Aspartyl-L-phenylalanine-L-methyl ester (Aspartame) ICS 67.220.20 X42 National Standards of People's Republic of China Food Additives Aspartic acid phenylalanine methyl ester (aspartame) Posted 2008-09-10 2009-03-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released

Foreword

Chapter 4 of this standard are mandatory, the remaining provisions are recommended. The standard reference to the Codex Alimentarius Commission (CAC) recommended the technical specifications (JECFA, 2001) and the United States "Food Chemicals Codex "(FCC) technical specifications of the content. Appendix A of this standard is a normative appendix. The standard proposed by China National Light Industry Council. This standard by the National Standardization Technical Committee on Food Additives, National Center for Standardization centralized food fermentation. This standard was drafted. Changzhou Niutang Chemical Plant Co., Ltd., China Food Fermentation Industry Research Institute, Shaoxing Yamei have bio-chemical Ltd., Jiangsu Han Kuang sweeteners Limited, Beijing Victor Chemical Co., Ltd. The main drafters of this standard. Renshu Zhi, Li Huiyi, Chen Kai, Shi Ming-kuen, Shen Ming, Li Ying, Chai Qiuer. Food Additives Aspartic acid phenylalanine methyl ester (aspartame)

1 Scope

This standard specifies the food additive aspartic acid phenylalanine methyl ester (aspartame) technical requirements, test methods, inspection rules, and Signs, packaging, transport and storage. This standard applies to the L- phenylalanine, L- aspartic acid prepared by the reaction of a food additive aspartyl-phenylalanine methyl ester (Aspen Aspartame).

2 Normative references

The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard. Preparation of GB/T 601 chemical reagent standard titration solution GB/T 602 Determination of impurities in chemical reagents prepared standard solution (GB/T 602-2002, ISO 6353-1. 1982, NEQ) with GB/T 603 chemical reagent test method Preparations of articles (GB/T 603-2002, ISO 6353-1 with. 1982, NEQ) General Method GB/T 613 chemical reagent assay (GB/T 613-2007, ISO 6353-1 than rotatory power (specific optical rotation). 1982, NEQ) Determination of GB/T 5009.3 moisture in foods Determination of GB/T 5009.4 ash in foods Determination of GB/T 5009.75 Lead in Food Additives GB/T 6682 analytical laboratory use specifications and test methods (GB/T 6682-2008, ISO 3696. 1987, MOD) 3 chemical name, molecular formula, molecular mass and structural formula 3.1 Chemical Name Aspartyl phenylalanine methyl ester. Formula 3.2 C14H18N2O5. 3.3 formula 3.4 relative molecular mass 294.31 (according to 2005 international relative atomic mass). 4. Technical Requirements 4.1 Characters White crystalline granules or powder, slightly soluble in water and ethanol. 4.2 Physical indicators Shall comply with the requirements of Table 1. Table 1 Physical and Chemical Indicators Item Index Content (dry basis) mass fraction /% 98.0 102.0 Specific rotation [α] 20D/(°) + 14.5 ~ + 16.5 Transmittance ≥ 0.95 Loss on drying mass fraction /% ≤ 4.5 Burning residue mass fraction /% ≤ 0.2 pH 4.5 ~ 6.0 Lead (Pb)/(mg/kg) ≤ 1 5-benzyl-3,6-dioxo-2-piperazin-acetic acid mass fraction /% ≤ 1.5 Other related mass fraction /% ≤ 2.0

5 Test methods

Unless otherwise indicated in the analysis using only recognized as analytical reagents and GB/T 6682 set forth in the water. Criteria used in the analysis Titration solution, impurity measurement standard solution, preparations and products, did not indicate when the other requirements, according to GB/T 601, GB/T 602, GB/T 603 provisions prepared. 5.1 Identification 5.1.1 Identification 1 Take 2G (hydrated) ninhydrin dissolved in dimethylsulfoxide 75mL, plus 62mg ninhydrin reduction with 4mol/L lithium acetate buffer (PH9) was diluted to 100mL, and filtered. Moved to 10mg sample tube, add 2mL reagent solution, heating, appear dark purple. 5.1.2 Identification of 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. After boiling cooling, hydrochloric acid was added to adjust the pH to 1-1.5, ferric chloride added 0.1mL Liquid, appears reddish brown. 5.2 Content 5.2.1 Method summary In glacial acetic acid as solvent, crystal violet as indicator, with a standard solution of perchloric acid in glacial acetic acid solution samples were non-aqueous titration. 5.2.2 Reagents and solutions 5.2.2.1 glacial acetic acid. 5.2.2.2 perchloric acid standard solution. 0.1mol/L, the preparation and calibration according to the provisions of GB/T 601's. 5.2.2.3 crystal violet indicator. According to the provisions of GB/T 603 is formulated at a concentration of 2g/L. 5.2.2.4 formic acid. 98%. 5.2.3 Analysis of 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 Standard solution titration, 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. 5.2.4 Calculation Results The content of the mass fraction X1 according to equation (1). X1 = (Vp 1- Vp 2) × 0.02943 100 (1) Where. X1 --- content mass fraction,%; Vp 1 --- perchlorate standard solution sample consumption volume in milliliters (mL); Vp 2 --- blank test consumption volume perchloric acid standard solution, in milliliters (mL); 0.02943 --- consumption per 1mL standard solution of perchloric acid at a concentration of 0.1mol/L equivalent aspartyl phenylalanine in grams Methyl ester (aspartame) (C14H18O25) quality; X0 --- Loss on drying of the sample mass fraction,%. 5.2.5 allowable difference 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. 5.3 Specific rotation [α] 20D Weigh about 4g sample (accurate to 0.0001g), the sample with a sufficient amount 15mol/L formic acid is dissolved 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. 5.4 transmittance 5.4.1 Method summary Product solution has the largest light transmittance at 430nm wavelength. 5.4.2 Instruments a) spectrophotometer; b) volumetric flask, pipette. 5.4.3 Analysis of step Weigh 0.5g sample was dissolved 2mol/L hydrochloric acid and dilute to 50mL, shake. With a 1cm cuvette at 430nm wavelength measured at Transmittance. With 2mol/L hydrochloric acid as control. The measurement results to one decimal place. 5.5 Loss on drying The method according to GB/T 5009.3 predetermined measurement (105 ℃, 4h). 5.6 Residue on ignition Weigh about 1.0g sample (accurate to 0.0001g), according to the method GB/T 5009.4 predetermined measurement. Weigh sample 0.80g, dissolved in water and dilute to 100mL, pH of the solution was measured by using acidity. 5.8 Lead The method according to GB/T 5009.75 predetermined measurement. 5.9 5-benzyl-3,6-dioxo-2-piperazin-acetic acid Measured by the method specified in Appendix A. 5.10 Other related objects Measured by the method specified in Appendix A.

6 Inspection rules

6.1 Batch determination Production unit determined by the product lot number in accordance with their respective rules, the final mixing and there is uniformity of quality products for the batch. 6.2 Sampling methods and sample size In each batch of products at random samples of each batch of sample extract 3% of the number of pieces of packaging, each batch of not less than three packs, each Sample of not less than 100g, the extracted sample rapidly mixed, distributed into two clean, dry bottle, marked on the bottle manufacturing plant, producing Product name, batch number, quantity and date of sampling bottle for examination, a bottle seal retained for future reference. 6.3 factory inspection 6.3.1 factory inspection items include content, specific rotation, transmittance, loss on drying, residue on ignition, pH, 5- benzyl-3,6-dioxo-2-piperazin Acetic acid and other related material. 6.3.2 Each batch of products subject to the inspection department of the production plant according to the method specified in this standard test and issued before the factory product certification. 6.4 Type inspection All items specified in the technical requirements of this standard are type inspection items. Type test once every year, or when the following One situation when tested. --- Raw materials, process large changes; After --- Discontinued resume production; --- Factory inspection results are quite different from normal recording time. 6.5 determine the rules When all the technical requirements for inspection, test results if an index does not meet the requirements of this standard should be re-double sampling multiplexes Inspection. Review the results even if one does not meet this standard, the entire batch of products as unqualified. When opposition parties, such as supply and demand for product quality arises, selected by mutual agreement of arbitration institutions, according to test methods specified in this standard of conduct arbitration. 7 signs, packaging, transportation and storage 7.1 marks Food additives must be packaged logo and product specifications, labeling should include. name, place of origin, manufacturer name, health permit number, Production license number, specifications, production date, lot number or code, shelf life, product standards, etc., and on the label clearly marked "food additives Additives "words. 7.2 Packaging Product packaging shall be approved by the state, and in accordance with relevant hygiene standards of food packaging materials. 7.3 Transportation and storage 7.3.1 products during transport shall not be mixed and carried toxic and hazardous substances and pollution, avoid the sun and rain and so on. 7.3.2 The product should be stored in well-ventilated, clean, dry place, not with toxic, hazardous and corrosive and other substances exist. Japanese 7.3.3 product from production date, in conformity with the above storage conditions, packaging intact, the shelf life of not less than 12 months.

Appendix A

(Normative) 5-benzyl-3,6-dioxo-2-piperazin-acetic acid (BDPA) and Determination of other substance (HPLC method) A. 1 Method summary Sample methanol solution [methanol. water = 1.9 (volume ratio)] was dissolved, equipped with a UV detector HPLC, external calibration Method. A. 2 Reagents and materials Unless otherwise indicated in the analysis using only recognized as analytical reagents and GB/T 6682 set forth in the water. A. 2.1 USP standard impurities BDPA. A. 2.2 potassium dihydrogen phosphate. A. 2.3 Methanol. chromatographically pure. A. 2.4 Dilution solution.200mL and 1800mL methanol and water mixing system. A. 3 instruments and equipment High performance liquid chromatograph. equipped with UV detector. A. 4 chromatographic conditions A. 4.1 Columns. Column filling octadecyl silica gel column 250mm × 4.6mm. A. 4.2 Mobile phase. Weigh 5.6g potassium dihydrogen phosphate to 1000mL volumetric flask, add 820mL water dissolved with phosphoric acid to adjust the pH 4.3, add 180mL of methanol, mix, dried 0.45μm filter membrane degassing. A. 4.3 Mobile phase flow rate. 2mL/min. A. 4.4 detection wavelength. 210nm. A. 4.5 Injection volume. 20μL. A. 4.6 column temperature. 40 ℃. NOTE. The system suitability relative standard error of triplicate injection area response of the standard solution was not more than 2.0%. A. Step 5 Analysis A. Preparation of standard solution of 5.1 BDPA Weigh accurately 25mgUSP standard impurities BDPA, placed in 100mL volumetric flask, add methanol 10mL dissolved, diluted with water To volume, and mix. Learn the solution to 50mL 15mL volumetric flask, diluted with dilute solution (A.2.4) to volume, and mix with 0.45μm microporous membrane filtration. The solution should be using now. A. 5.2 Preparation of sample solution Accurately weighed sample of 50mg taken, placed in 10mL volumetric flask, diluted with dilute solution (A.2.4) to volume, and mix with 0.45μm microporous membrane filtration. The solution should be using now. A. Determination of 5.3 BDPA They were injected by A. 5.1 and A. BDPA 5.2 standard solution and sample solution prepared in each 20μL, record chromatograms and chromatograms BDPA peak area response value. BDPA retention time is about 4min; aspartic acid phenylalanine methyl ester (aspartame) retention time Between about 11min. A. Results 6 BDPA content calculation BDPA mass fraction according to formula (A.1) Calculated. × 1000 (A.1) Where. X2 --- sample BDPA mass fraction,%; AU --- BDPA peak area response value in the sample; S --- BDPA Ba concentration in the standard solution, in milligrams per milliliter (mg/mL); AS --- BDPA peak area response value in the standard; A. Determination of 7 other objects and judgment A. 7.1 Preparation of other relevant material standard solution Lessons for the test solution BDPA content detection flask in 2mL to 100mL, diluted engraved with a dilute solution (A.2.4) Degree, and mix. A. 7.2 Determination and judgment They were injected by A. 7.1 and A. Other relevant material standard solution and sample solution 20μL 5.2 preparation, the recording time is two chromatographic Fold aspartyl phenylalanine methyl ester (aspartame) retention time. Removing the BDPA peak area response value, the other peak area of sample solution Value not greater than the sum of the response was related to other standard solutions obtained aspartic acid phenylalanine methyl ester (aspartame) peak area response We should value. ......

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