YY/T 0962-2021 (YY/T0962-2021, YYT 0962-2021, YYT0962-2021) & related versions
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Cross-linked sodium hyaluronate gel for plastic surgery
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YY/T 0962-2021
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Cross-linked sodium hyaluronate gel for plastic surgery
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YY/T 0962-2021: PDF in English (YYT 0962-2021)
YY/T 0962-2021
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 45
Replacing YY/T 0962-2014
Cross-Linked Sodium Hyaluronate Gel for Plastic Surgery
ISSUED ON: SEPTEMBER 06, 2021
IMPLEMENTED ON: SEPTEMBER 01, 2022
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative References ... 5
3 Terms and Definitions ... 5
4 Requirements for Materials ... 6
5 Requirements ... 6
6 Inspection Methods ... 8
7 Packaging ... 10
8 Markings ... 10
Appendix A (Normative) Determination of Pushing Force ... 13
Appendix B (Normative) Determination of Swelling Degree ... 14
Appendix C (Normative) Determination of Sodium Hyaluronate Content ... 15
Appendix D (Normative) Determination of Protein Content ... 18
Appendix E (Normative) Determination of Residual Amount of Crosslinking Agent
1,4-Butanediol Diglycidyl Ether (BDDE) ... 20
Appendix F (Normative) Determination of Free Sodium Hyaluronate Content ... 24
Cross-Linked Sodium Hyaluronate Gel for Plastic Surgery
1 Scope
This Standard specifies the requirements, inspection methods, packaging and information
provided by the manufacturer of cross-linked sodium hyaluronate gel for plastic surgery
(hereinafter referred to as cross-linked sodium hyaluronate gel).
This Standard applies to cross-linked sodium hyaluronate gel.
NOTE: Cross-linked sodium hyaluronate gel is suitable for filling of skin and subcutaneous tissue.
2 Normative References
The following documents are essential to the application of this document. For the dated
documents, only the versions with the dates indicated are applicable to this document; for the
undated documents, only the latest version (including all the amendments) is applicable to this
document.
GB/T 16886.1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
within a Risk Management Process
YY/T 1571 Tissue Engineering Medical Device Products - Sodium Hyaluronate
Pharmacopoeia of the People's Republic of China (IV Volumes) 2020 Edition
3 Terms and Definitions
For the purposes of this Document, the following terms and definitions apply.
3.1 Hyaluronic acid
A linear polysaccharide that is composed of disaccharide repeating structural units formed by
connecting D-glucuronic acid and N-acetyl-D-glucosamine through β-(1-3) glycosidic bond.
Each disaccharide unit is linked to another disaccharide unit by a β-(1-4) glycosidic bond.
Hyaluronic acid generally exists in the form of sodium salt, namely sodium hyaluronate.
3.2 Cross-linking agent
Substance that is used for cross-linking of sodium hyaluronate.
3.3 Cross-linked sodium hyaluronate gel
The biological evaluation shall be carried out in accordance with the requirements of GB/T
16886.1.
5.19 Degradation properties
The degradation of cross-linked sodium hyaluronate refers to the degradation in vivo to the
disappearance of the material under the local microscope by histological observation, excluding
the further metabolic process of the material outside the implanted site. If the degradation time
of the product is too long, other suitable methods can be used for degradation test.
6 Inspection Methods
6.1 Appearance
The cross-linked sodium hyaluronate gel is placed under the illumination of 1000lx~1500lx for
random rotation observation, which shall comply with the provisions of 5.1.
6.2 Effective usage amount
Take out the cross-linked sodium hyaluronate gel in each single package as much as possible
according to the normal use method; weigh it and then divide it by the density of the cross-
linked sodium hyaluronate gel (ρ=1.01g/mL), which shall comply with the provisions of 5.2.
6.3 Particle size distribution
It shall be determined according to Determination Method of 0982 Particle Size and Particle
Size Distribution - The Third Method (Light Scattering Method) – Wet Method in
Pharmacopoeia of the People's Republic of China (VI Volumes) (2020 Edition), and shall
comply with the provisions of 5.3.
6.4 Pushing force
Determined according to the method in Appendix A, it shall comply with the provisions of 5.4.
6.5 Infrared identification
Dry an appropriate amount of cross-linked sodium hyaluronate gel by freeze-drying method,
ethanol precipitation and drying method or direct drying method (80°C and below); and then
use potassium bromide to press into tablets; and then it shall be determined according to the
0402 Infrared Spectrophotometry in Pharmacopoeia of the People's Republic of China (IV
Volumes) (2020 Edition), and shall comply with the provisions of 5.5.
6.6 Swelling degree
Determined according to the method in Appendix B, it shall comply with the provisions of 5.6.
6.7 Osmotic pressure
Direct sampling, it shall be determined according to the Determination Method of 0632 Molar
Concentration of Osmotic Pressure in Pharmacopoeia of the People's Republic of China (VI
Volumes) (2020 Edition), and shall comply with the provisions of 5.7.
6.8 pH value
The cross-linked sodium hyaluronate gel is diluted with purified water in an equal mass ratio;
and it is determined according to the Determination Method of 0631 pH Value in
Pharmacopoeia of the People's Republic of China (VI Volumes) (2020 Edition), and shall
comply with the provisions of 5.8.
6.9 Sodium hyaluronate content
Determined according to the method in Appendix C, it shall comply with the provisions of 5.9.
6.10 Protein
Determined according to the method in Appendix D, it shall comply with the provisions of 5.10.
6.11 Total amount of heavy metals
It shall be determined according to the Second Method of 0821 Heavy Metal Inspection Method
in Pharmacopoeia of the People's Republic of China (VI Volumes) (2020 Edition), and shall
comply with the provisions of 5.11.
6.12 Residual amount of cross-linking agent
Determined according to the method in Appendix E, it shall comply with the provisions of 5.12.
If other cross-linking agents are used, limit requirements and inspection methods shall be
provided.
The test methods for the residual amount of all cross-linking agents shall be able to detect the
residual amount of cross-linking agent in the cross-linked sodium hyaluronate particles together.
6.13 Free sodium hyaluronate content
Determined according to the method in Appendix F, it shall comply with the provisions of 5.13.
6.14 Other additives
If other additives are added in the production process, their limit requirements and inspection
methods shall be provided.
6.15 Sterile
It shall be inspected according to the 1101 Sterility Inspection Method in Pharmacopoeia of
Appendix A
(Normative)
Determination of Pushing Force
A.1 Principle
In this test, the injection core rod is pushed at a constant speed; and the injection needle is
installed during the test to simulate the actual use situation. Push the core rod at a constant
speed; the sample in the syringe is pushed out through the needle; and the push force curve is
obtained. From the pushing force curve, the change of the pushing force during the extrusion
process of the sample can be observed. If the pushing force is small, the sample is easily
extruded; if the pushing force is large, the sample is difficult extruded. In addition, if the high
and low drop of the pushing force is large, it shall indicate the sample has uneven dispersion or
aggregation and concentration, which shall also affect the chirality during injection.
A.2 Instrument
Universal material testing machine.
A.3 Test method
Remove the outer packaging of the product; install the matching core rod and injection needle
in the package; discharge a small amount of air at the front end of the syringe; and then install
it on the testing equipment; and set the testing parameters of the testing equipment (universal
material testing machine).
The test conditions are as follows:
a) test temperature: room temperature.
b) equilibration time at room temperature (for products stored in refrigerated conditions):
take out the product and equilibrate at room temperature for 1h before testing.
c) test distance: set the test distance to full scale.
d) pushing speed: set the pushing speed to 30mm/min.
Test the pushing force according to the prescribed method; and record the maximum pushing
force, the minimum pushing force and the average pushing force in the platform area of the
pushing force curve.
Appendix C
(Normative)
Determination of Sodium Hyaluronate Content
C.1 Principle
After the hydrolysis of sodium hyaluronate, glucuronic acid reacts with carbazole reagent to
produce reddish purple, the resulting color depth is proportional to the content of glucuronic
acid.
C.2 Instrument
Electronic balance (with accuracy of 0.1mg), UV-Vis spectrophotometer, vortex mixer or
equivalent equipment.
C.3 Preparation of solution
C.3.1 Carbazole ethanol solution with volume fraction of 0.125%
Weigh 0.125g of carbazole; add 100mL of absolute ethanol to dissolve. Transfer to a dark brown
bottle and store in a dark place; it is valid for 15 days.
C.3.2 Glucuronic acid (GA) standard solution
Accurately weigh about 0.1g of glucuronic acid reference substance; put it in a 100mL
volumetric flask; add water to dissolve and dilute to the mark; shake well; take as a stock
solution; and store at 2 ℃ ~ 8 ℃. Before use, accurately take 5.0mL of the stock solution; put
it in a 100mL volumetric flask; add water to make a solution containing 50μg per 1mL.
C.3.3 0.025mol/L sodium tetraborate sulfuric acid solution
Weigh 9.54 g of sodium tetraborate (Na2B4O7 • 10H2O); add it to 1L of concentrated sulfuric
acid; and cover it. Shake occasionally until the sodium tetraborate is completely dissolved.
Stored at room temperature; it is valid for 12 months.
C.3.4 0.5mol/L sulfuric acid solution
Take 5 mL of 98% sulfuric acid; add it to a beaker containing 179 mL of water; and mix well.
C.3.5 1mol/L sodium hydroxide solution
Take 10 g of sodium hydroxide; add 250 mL of water; and stir to dissolve.
C.3.6 Test solution
Appendix E
(Normative)
Determination of Residual Amount of Crosslinking Agent 1,4-Butanediol
Diglycidyl Ether (BDDE)
E.1 Enzyme-labelled method
E.1.1 Principle
This method is the one to detect the high sensitivity of the epoxy compounds. The epoxy
compound reacts with nicotine and produces fluorescence under the action of excitation light
of 370nm; and its fluorescence intensity is proportional to the amount of epoxy compound. The
fluorescence intensity can be detected by fluorescence spectrophotometer at the emission
wavelength of 430nm.
E.1.2 Instrument and reagent
Multifunctional microplate reader (or fluorescence spectrophotometer), electronic balance
(with accuracy of 0.1mg), constant temperature water bath, and micro sample injector.
Hyaluronidase, BDDE, nicotinamide, acetophenone, potassium hydroxide, formic acid, ethanol.
NOTE: The above reagents are at least analytically pure.
E.1.3 Preparation of solution
E.1.3.1 2.0mg/mL BDDE standard stock solution
Accurately weigh 0.1g of BDDE into a 50mL volumetric flask; add purified water; mix well
make constant volume; and set aside for later use.
E.1.3.2 125mmol/L nicotinamide solution
Accurately weigh 0.76g of nicotinamide into a 50mL volumetric flask; add purified water; make
constant volume; mix well; and set aside for later use.
E.1.3.3 15% acetophenone solution
Pipette 1.5mL of acetophenone solution into a 10mL volumetric flask; add absolute ethanol to
make the constant volume; and mix well for later use (due to the poor solubility of acetophenone
in water, anhydrous ethanol is used here).
E.1.3.4 1mol/L potassium hydroxide solution
E.2.1 Principle
The separation principle of gas chromatography is to use the difference in the distribution of
the components to be separated between the mobile phase and the stationary phase. When the
two phases move relative to each other, the distribution of these components between the two
phases is repeated. Even if the distribution coefficient of the components has only minor
differences, and there can be significant differences as the mobile phase moves; and finally,
these components are separated. Each component enters the detector successively; and the
chromatographic signal is recorded by the data processing system.
E.2.2 Instrument and reagent
Gas chromatograph (FID detector), electronic balance (with accuracy of 0.1mg), 1,4-butanediol
diglycidyl ether (BDDE), ethyl acetate (chromatographically pure), hyaluronidase (HAse).
E.2.3 Reference chromatographic conditions
Chromatographic column: DM-17 or DM-5 (30m×0.32mm×0.25μm) and other similar
chromatographic columns.
Column temperature: the initial temperature is 200 °C; maintains for 5 min; and then increase
to 280 °C at 20 °C/min; and maintain for 5 min.
Detector: FID.
Carrier gas: N2.
Injection port temperature: 240°C.
Detector temperature: 280°C.
Carrier gas flowrate: 1.5mL/min.
Sample-injecting volume: 2μL.
Split ratio: 1:1.
E.2.4 Preparation of solution
E.2.4.1 Preparation of HAse solution
A fresh HAse solution is prepared by dissolving 25 mg of hyaluronidase in 10 mL of water.
E.2.4.2 Standard stock solution
Accurately weigh about 100mg of BDDE standard substance; put it in a 100mL volumetric
flask; and dilute to the mark with water (stock solution A). Transfer 10mL of stock solution A
to a 100mL volumetric flask; and dilute with water to the mark (stock solution B). Transfer
Appendix F
(Normative)
Determination of Free Sodium Hyaluronate Content
F.1 Principle
After the hydrolysis of sodium hyaluronate, glucuronic acid reacts with carbazole reagent to
produce reddish purple; and the resulting color depth is proportional to the content of glucuronic
acid.
F.2 Instrument
Electronic balance (with accuracy of 0.1mg), UV-Vis spectrophotometer, vortex mixer or
equivalent equipment.
F.3 Preparation of solution
F.3.1 Carbazole ethanol solution with a volume fraction of 0.125%: Weigh 0.125 g of carbazole;
add 100 mL of absolute ethanol to dissolve. Transfer to a dark brown bottle and store in a dark
place; it is valid for 15 days.
F.3.2 Glucuronic acid (GA) standard solution: Precisely weigh about 0.1 g of glucuronic acid
reference substance; put it in a 100 mL volumetric flask; add water to dissolve and dilute to the
mark; shake well; take as a stock solution; store at 2 ℃ ~ 8 ℃. Before use, accurately pipette
5.0mL of the stock solution; put it in a 100mL volumetric flask; add water to make a solution
containing 50μg per 1mL.
F.3.3 0.025mol/L sodium tetraborate sulfuric acid solution: Weigh 9.54 g of sodium tetraborate
(Na2B4O7•10H2O); add it to 1L of concentrated sulfuric acid; and cover. Shake occasionally
until the sodium tetraborate is completely dissolved. Store at room temperature; it is valid for
12 months.
NOTE: The reagents used in the test are analytically pure; and the sulfuric acid should be of guaranteed
reagent.
F.4 Preparation of the test solution
Take an appropriate amount of cross-linked sodium hyaluronate gel and place it in an accurately
pre-weighed volumetric flask, accurately weigh it (accurate to 0.1 mg); and record the gel mass
as m1; add an appropriate amount of purified water to dilute to the mark, and accurately weigh
it (the mass of cross-linked sodium hyaluronate gel and water in the volumetric flask is recorded
as m2); so that the content of free sodium hyaluronate in the diluent is within the linear range
of the standard curve; and fully shake and mix well. Then filter with slow filter paper; take 1mL
of the filtrate and put it in a test tube as the test solution. Or centrifuge the diluent at 15000r/min
......
| Standard ID | YY/T 0962-2021 (YY/T0962-2021) | | Description (Translated English) | Cross-linked sodium hyaluronate gel for plastic surgery | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C45 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 22,244 | | Date of Issue | 2021-09-06 | | Date of Implementation | 2022-09-01 | | Summary | This standard specifies the requirements, inspection methods, packaging and information provided by the manufacturer of cross-linked sodium hyaluronate gel for plastic surgery (hereinafter referred to as cross-linked sodium hyaluronate gel). This standard applies to cross-linked sodium hyaluronate gel. |
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