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QB/T 4576-2023Sodium hyaluronate (English PDF)

透明质酸钠

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Issued by

MIIT

Level / Type

Industry · Recommended

Issue date

December 29, 2023

Implementation date

July 1, 2024

Scope

QB/T 4576-2023 is the English-translated version of 透明质酸钠.

QB/T 4576-2023 is the Chinese light-industry product standard for sodium hyaluronate made by fermentation, the hyaluronic acid traded as a raw material. It applies to material produced by fermenting Streptococcus equi subsp. zooepidemicus on glucose, yeast extract, peptone and similar nutrients, and gives producer and buyer common requirements for identification, sensory properties, physicochemical properties and safety, with the test methods, inspection rules, and marking, packaging, transportation and storage. It states the molecular formula, relative molecular mass and structural formula of the product, and gives two normative methods for the sodium hyaluronate content: spectrophotometry in Annex A and high performance liquid chromatography in Annex B, with reference chromatograms in Annex C. Microbiological counts, moisture, ash, lead and arsenic are determined with the GB 4789 and GB 5009 food-safety methods. Issued by MIIT on 29 December 2023 and applicable since 1 July 2024, it replaces QB/T 4576-2013.

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Document preview — QB/T 4576-2023

National Standard of the People's Republic of China

Replacing
QB/T 4576-2013

Issued by: Ministry of Industry and Information Technology of the People's Republic of China

Contents

  • Foreword
  • 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

Foreword

This document was issued on 29 December 2023 by the Ministry of Industry and Information Technology of the People's Republic of China, and has applied since 1 July 2024.

It replaces QB/T 4576-2013.

It is a QB/T standard: a recommended industry standard of China's light industry.

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 beta-D-N-acetylglucosamine and beta-D-glucuronic acid linked via beta-1,3-glycosidic bonds, which are further linked via beta-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.

Remaining clauses in the full document

  • 5 Requirements
  • 6 Test methods
  • 7 Inspection rules
  • 8 Marking, packaging, transportation and storage
  • A Annex A (normative) Sodium hyaluronate content - Spectrophotometric method
  • B Annex B (normative) Sodium hyaluronate content - High performance liquid chromatography method
  • C Annex C (informative) High performance liquid chromatograms of sodium hyaluronate

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 12 pages — is available in the English PDF.

Referenced standards

Normative references

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

Similar standards

Editions of QB/T 4576

EditionTitleRevisionStatus
QB/T 4576-2023Sodium hyaluronatecurrent editionCurrent
QB/T 4576-2013Sodium hyaluronateprevious editionSuperseded

This page sells the current edition, QB/T 4576-2023. Earlier editions are listed for reference only.

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