QB/T 4576-2023 Sodium hyaluronate
1 Scope
This document specifies the requirements for identification, sensory properties, physicochemical properties and safety of sodium hyaluronate, describes the corresponding test methods, specifies the inspection rules, marking, packaging, transportation and storage, and provides information on the molecular formula, relative molecular mass and structural formula.
This document is applicable to the production, inspection and sale of sodium hyaluronate produced by fermentation of Streptococcus equi subsp. zooepidemicus using glucose, yeast extract, peptone, etc. as raw materials.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 191 Packaging - Pictorial marking for handling of goods
GB/T 601 Chemical reagent - Preparations of reference titration solutions
GB/T 602 Chemical reagent - Preparations of standard solutions for impurity
GB/T 603-2023 Chemical reagent - Preparations of reagent solutions for use in test methods
GB 4789.2 National food safety standard - Food microbiological examination - Aerobic plate count
GB 4789.3 National food safety standard - Food microbiological examination - Enumeration of coliforms
GB 4789.15 National food safety standard - Food microbiological examination - Enumeration of moulds and yeasts
GB 5009.3 National food safety standard - Determination of moisture in foods
GB 5009.4 National food safety standard - Determination of ash in foods
GB 5009.11 National food safety standard - Determination of total arsenic and abio-arsenic in foods
GB 5009.12 National food safety standard - Determination of lead in foods
GB/T 6682 Water for analytical laboratory use - Specification and test methods
GB 7718 National food safety standard - General standard for the labeling of prepackaged foods
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
sodium hyaluronate
sodium salt of hyaluronic acid, a chain-like high-molecular acidic mucopolysaccharide composed of disaccharide structural units formed by β-D-N-acetylglucosamine and β-D-glucuronic acid linked via β-1,3-glycosidic bonds, which are further linked via β-1,4-glycosidic bonds
Note: Commercial sodium hyaluronate is also referred to as "hyaluronic acid", etc.
4 Molecular formula, relative molecular mass and structural formula
4.1 Molecular formula
(C₁₄H₂₀NNaO₁₁)ₙ.
Contents
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Molecular formula, relative molecular mass and structural formula
5 Requirements
6 Test methods
7 Inspection rules
8 Marking, packaging, transportation and storage
Annex A (Normative) Sodium hyaluronate content——Spectrophotometric method
Annex B (Normative) Sodium hyaluronate content——High performance liquid chromatography method
Annex C (Informative) High performance liquid chromatograms of sodium hyaluronate
QB/T 4576-2023 Sodium hyaluronate
1 Scope
This document specifies the requirements for identification, sensory properties, physicochemical properties and safety of sodium hyaluronate, describes the corresponding test methods, specifies the inspection rules, marking, packaging, transportation and storage, and provides information on the molecular formula, relative molecular mass and structural formula.
This document is applicable to the production, inspection and sale of sodium hyaluronate produced by fermentation of Streptococcus equi subsp. zooepidemicus using glucose, yeast extract, peptone, etc. as raw materials.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 191 Packaging - Pictorial marking for handling of goods
GB/T 601 Chemical reagent - Preparations of reference titration solutions
GB/T 602 Chemical reagent - Preparations of standard solutions for impurity
GB/T 603-2023 Chemical reagent - Preparations of reagent solutions for use in test methods
GB 4789.2 National food safety standard - Food microbiological examination - Aerobic plate count
GB 4789.3 National food safety standard - Food microbiological examination - Enumeration of coliforms
GB 4789.15 National food safety standard - Food microbiological examination - Enumeration of moulds and yeasts
GB 5009.3 National food safety standard - Determination of moisture in foods
GB 5009.4 National food safety standard - Determination of ash in foods
GB 5009.11 National food safety standard - Determination of total arsenic and abio-arsenic in foods
GB 5009.12 National food safety standard - Determination of lead in foods
GB/T 6682 Water for analytical laboratory use - Specification and test methods
GB 7718 National food safety standard - General standard for the labeling of prepackaged foods
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
sodium hyaluronate
sodium salt of hyaluronic acid, a chain-like high-molecular acidic mucopolysaccharide composed of disaccharide structural units formed by β-D-N-acetylglucosamine and β-D-glucuronic acid linked via β-1,3-glycosidic bonds, which are further linked via β-1,4-glycosidic bonds
Note: Commercial sodium hyaluronate is also referred to as "hyaluronic acid", etc.
4 Molecular formula, relative molecular mass and structural formula
4.1 Molecular formula
(C₁₄H₂₀NNaO₁₁)ₙ.
Contents of QB/T 4576-2023
Contents
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Molecular formula, relative molecular mass and structural formula
5 Requirements
6 Test methods
7 Inspection rules
8 Marking, packaging, transportation and storage
Annex A (Normative) Sodium hyaluronate content——Spectrophotometric method
Annex B (Normative) Sodium hyaluronate content——High performance liquid chromatography method
Annex C (Informative) High performance liquid chromatograms of sodium hyaluronate