GB 1903.43-2020National food safety standard - Food Nutritional Fortification Substance - Cyanocobalamin cobione (English PDF)
食品安全国家标准 食品营养强化剂 氰钴胺
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Issued by
National Health Commission and State Administration for Market Regulation
Level / Type
National · Mandatory
Issue date
September 11, 2020
Implementation date
March 11, 2021
Scope
GB 1903.43-2020 is the English-translated version of 食品安全国家标准 食品营养强化剂 氰钴胺.
GB 1903.43-2020 is the Chinese national food safety standard for cyanocobalamin used as a food nutritional fortification substance, obtained by transforming and crystallising a fermentation broth that contains cobalamin produced by microbial fermentation.
It gives the molecular formula C63H88CoN14O14P, the structural formula and the relative molecular mass 1355.38, then the technical requirements.
Appendix A carries the test methods, with a warning on the toxic and corrosive reagents, the general rules on reagents and water referring to GB/T 601, GB/T 602, GB/T 603 and GB/T 6682, the identification test, the loss on drying and the determination of related substances by liquid chromatography.
Appendix B gives the infrared spectrum of the cyanocobalamin standard and Appendix C the acetone gas chromatogram. It was issued on 11 September 2020 and has applied since 11 March 2021.
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Document preview — GB 1903.43-2020
National Standard of the People's Republic of China
Issued by: National Health Commission and State Administration for Market Regulation
Contents
- 1 Scope3
- 2 Molecular Formula, Structural Formula and Relative Molecular Mass3
- 3 Technical Requirements4
- Appendix A Test Methods5
- Appendix B Infrared Spectrum of Cyanocobalamin Standard Product14
- Appendix C Acetone Gas Chromatogram15
1 Scope
This Standard is applicable to cyanocobalamin, a food nutritional fortification substance obtained through transformation and crystallization of fermentation broth containing cobalamin produced by microbial fermentation.
2 Molecular formula, structural formula and relative molecular mass
2.1 Molecular formula
C63H88CoN14O14P
2.2 Structural formula
2.3 Relative molecular mass
Cyanocobalamin: 1355.38 (according to 2018 international relative atomic mass)
Appendix A Test Methods
A.1 Warning
Some reagents used in the test methods of this Standard are toxic or corrosive, and appropriate safety and protective measures shall be taken during operation.
A.2 General rules
Unless otherwise specified in this Standard, the purity of the used reagents shall be analytically pure. The standard titration solution, standard solution for impurity determination, preparations and products shall be prepared in accordance with the provisions of GB/T 601, GB/T 602, and GB/T 603. The water used in the laboratory shall comply with the provisions of Class-3 water specified in GB/T 6682. The solution used in the test refers to an aqueous solution when it is not specified which solvent is used to prepare it.
A.3 Identification test
A.3.1 Reagents and materials
A.3.1.1 Acetone.
A.3.1.2 Chloroform.
A.3.1.3 Ether.
A.3.1.4 Hydrochloric acid.
A.3.1.5 Sodium acetate.
A.3.1.6 Potassium bromide.
A.3.1.7 Sodium fluoride.
A.3.1.8 Potassium hydrogen sulfate.
A.3.1.9 Hypophosphorous acid.
A.3.1.10 Phenolphthalein indicator.
A.3.1.11 Acetic acid (1mol/L).
A.3.1.12 Sodium hydroxide solution (100g/L): Take 10g of sodium hydroxide; add water to dissolve and make constant volume to 100mL.
A.6 Related substances
A.6.1 Principle of the method
After the specimen is dissolved in the mobile phase; it is detected by a liquid chromatograph and quantified by the peak area comparison method.
A.6.2 Reagents and materials
A.6.2.1 Chloramine T.
A.6.2.2 Methanol.
A.6.2.3 Disodium hydrogen phosphate.
A.6.2.4 Phosphoric acid.
A.6.2.5 Hydrochloric acid.
A.6.2.6 Disodium hydrogen phosphate solution: 0.028mol/L. Take 10.03g of disodium hydrogen phosphate dodecahydrate; add water to dissolve and make constant volume to 1000mL.
A.6.2.7 Hydrochloric acid solution: 0.05mol/L. Take 4.5mL of hydrochloric acid; add water to 1000mL; and mix well.
A.6.2.8 Chloramine T solution: 0.1%. Take 0.1g of chloramine T; add water to dissolve and make constant volume to 100mL.
A.6.3 Apparatus
A.6.3.1 Balance: Sensitivity 0.0001g.
A.6.3.2 High performance liquid chromatograph: equipped with ultraviolet detector.
A.6.4 Analytical procedures
A.6.4.1 Specimen solution: Take 10mg of specimen into a 10mL volumetric flask; dissolve it with mobile phase and make constant volume to the mark; and mix well.
A.6.4.2 Control solution: Accurately pipette 1mL of specimen solution in a 100mL […]
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