QB/T 4576-2023 English PDF (QBT4576-2023)

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QB/T 4576-2023: Sodium hyaluronate
QB/T 4576-2023
QB
LIGHT INDUSTRY STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 67.180
CCS X 69
Replacing QB/T 4576-2013
Sodium hyaluronate
透明质酸钠
ISSUED ON. DECEMBER 20, 2023
IMPLEMENTED ON. JULY 01, 2024
Issued by. Ministry of Industry and Information Technology of the PRC
Table of Contents
Foreword... 3
1 Scope... 5
2 Normative references... 5
3 Terms and definitions... 6
4 Molecular formula, relative molecular mass, structural formula... 6
5 Requirements... 7
6 Test method... 8
7 Inspection rules... 10
8 Marking, packaging, transportation, storage... 11
Appendix A (Normative) Sodium hyaluronate content - Spectrophotometer method 13
Appendix B (Normative) High-performance liquid chromatography method for sodium
hyaluronate content... 16
Appendix C (Informative) High-performance liquid chromatogram of sodium
hyaluronate... 19
Sodium hyaluronate
1 Scope
This document specifies the identification, sensory, physical and chemical, safety and
other requirements of sodium hyaluronate; describes the corresponding test methods;
specifies the inspection rules, marking, packaging, transportation, storage content;
gives the information of molecular formula, relative molecular mass, structural formula.
This document applies to the production, inspection, and sale of sodium hyaluronate
produced by fermentation of Streptococcus equi subspecies zooepidemicus with
glucose, yeast powder, peptone, etc. as raw materials.
2 Normative references
The contents of the following documents constitute essential clauses of the text through
normative references in the text. Among them, for dated references, only the version
corresponding to that date applies to this document; for undated references, the latest
version (including all amendments) applies to this document.
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 - Microbiological examination of food.
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 food
GB 5009.4 National food safety standard - Determination of ash in foods
GB 5009.11 National food safety standards - Determination of total arsenic and
Determine according to Appendix A or Appendix B, using Appendix A as the arbitration
method.
6.5 Moisture
Make measurement according to the method 1 "Direct drying method" of GB 5009.3,
where the drying time is 4 h.
6.6 Ash
Make measurement according to the method 1 "total ash" of GB 5009.4.
6.7 pH
6.7.1 Water
Distilled water without carbon dioxide. It is prepared according to 5.1.1.7 of GB/T 603-
2023.
6.7.2 Instruments and equipment
pH meter. Accuracy of 0.01.
Magnetic stirrer.
Thermostatic water bath. Accuracy of ±0.5 °C.
6.7.3 Determination steps
Weigh 0.1 g of sodium hyaluronate sample (accurate to 0.01 g). Add 100 mL of distilled
water without carbon dioxide. Dissolve by magnetic stirring or heating in a 40 °C water
bath. Measure the pH of the solution with a pH meter. The result is rounded to one
decimal place.
6.8 Lead (measured as Pb)
It is determined according to the method of GB 5009.12.
6.9 Arsenic (measured as As)
It is determined according to the method of GB 5009.11.
6.10 Mold and yeast
It is determined according to the method of GB 4789.15.If the sample cannot be
dissolved, add an appropriate amount of sterile hyaluronidase to help the sample
dissolve.
6.11 Total colony count
7.4 Exit-factory inspection
The exit-factory inspection items are sensory requirements, sodium hyaluronate content
(on a dry basis), pH, moisture, total colony count, mold and yeast, and coliform group.
7.5 Type inspection
The type inspection items are all the items specified in the requirements of this
document. Generally, type inspection is carried out every six months. Type inspection
shall also be carried out in any of the following situations.
a) Where there are major changes in raw and auxiliary materials;
b) Where key processes or equipment are changed;
c) When the new trial products is produced or when the production is restored after
production suspension of 3 months;
d) Where there is a big difference between the exit-factory inspection and the last
type inspection results;
e) Where the national market supervision agency needs to conduct random
inspections according to relevant requirements.
7.6 Judgment rules
If the inspection results show that one item of the product does not meet the
requirements of this document, samples shall be taken from twice the amount of
packaging for re-inspection; the re-inspection results shall prevail. If there is still one
unqualified item, the batch of products shall be judged as unqualified products. If the
inspection results show that two or more items of the product do not meet the
requirements of this document, the batch of products shall be judged as unqualified
products.
8 Marking, packaging, transportation, storage
8.1 Marking
The outer packaging marking shall comply with the provisions of GB/T 191.Pre-
packaged product labels shall comply with the provisions of GB 7718.For signs with
special requirements, they shall be marked as required by the purchaser.
8.2 Packaging
The packaging materials that meet the packaging requirements of the corresponding
industry products shall be used and can only be used after passing the inspection.
Strictly seal to prevent the product from absorbing moisture and leaking. For packaging
Appendix A
(Normative)
Sodium hyaluronate content - Spectrophotometer method
A.1 Principle
Hyaluronic acid contains N-acetylglucosamine and glucuronic acid in equal molar
ratios. Using borax as a catalyst to hydrolyze sodium hyaluronate with sulfuric acid can
separate glucuronic acid. Glucuronic acid reacts with carbazole to form an organic
complex, which shows a unique purple color; its absorbance is proportional to the mass
concentration of glucuronic acid. The content of sodium hyaluronate can be determined
by the content of glucuronic acid.
A.2 Reagents and solutions
A.2.1 Standard. D-glucuronic acid, CAS No.6556-12-3, purity not less than 98%.
A.2.2 Concentrated sulfuric acid. High purity.
A.2.3 Carbazole.
A.2.4 Borax.
A.2.5 Anhydrous ethanol.
A.2.6 Carbazole ethanol solution (1.25 g/L). Weigh 0.125 g of carbazole (accurate to
0.001 g); dissolve it in 100 mL of anhydrous ethanol; place it in a brown bottle. Store
in an explosion-proof refrigerator at 4 °C ~ 8 °C, which has a shelf life of 2 months; or
store in the dark at room temperature, which has a shelf life of 15 days.
A.2.7 D-glucuronic acid standard solution (0.2 mg/mL). Accurately weigh 20 mg of D-
glucuronic acid standard (accurate to 0.0001 g according to actual purity); place it in a
100 mL volumetric flask; add water to dissolve and dilute to the mark; shake well for
later use.
A.2.8 Borax-sulfuric acid solution (0.025 mol/L). Weigh 4.77 g of borax (accurate to
0.001 g); dissol...