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YY/T 0719.8-2019 (YYT0719.8-2019)

YY/T 0719.8-2019_English: PDF (YYT 0719.8-2019, YYT0719.8-2019)
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BASIC DATA
Standard ID YY/T 0719.8-2019 (YY/T0719.8-2019)
Description (Translated English) Ophthalmic optics -- Contact lens care products -- Prat 8: Test method for detergent
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C40
Classification of International Standard 11.040.70
Word Count Estimation 7,796
Date of Issue 2019
Date of Implementation 2020-10-01
Summary This standard specifies the test method for the determination of the active ingredient cleaning agent in contact lens care products (referred to as care products) as poloxamer or ethylene oxide hydrogenated castor oil. This standard applies to care products containing poloxamer or ethylene oxide hydrogenated castor oil as the active ingredient of the cleaning agent.

Standards related to: YY/T 0719.8-2019

YY/T 0719.8-2019
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.70
C 40
Ophthalmic optics - Contact lens care products -
Part 8: Test method for detergent
ISSUED ON: OCTOBER 23, 2019
IMPLEMENTED ON: OCTOBER 01, 2020
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative references ... 4 
3 General rule ... 4 
4 Test method ... 4 
5 Test report ... 8 
Annex A (informative) Typical liquid chromatogram of poloxamer ... 10 
Ophthalmic optics - Contact lens care products -
Part 8: Test method for detergent
1 Scope
This Part of YY/T 0719 specifies the test method to determine the content of
Poloxamer or epoxy ethylene hydrogenated castor oil as active ingredient in
contact lens care products (hereinafter referred to as care products).
This Part is applicable to care products that the active ingredient of the
detergent is poloxamer or epoxy ethylene hydrogenated castor oil.
2 Normative references
The following referenced documents are indispensable for the application 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 6682, Water for analytical laboratory use - Specification and test
methods
3 General rule
The test method specified in this Part shall be carried out at room temperature,
that is, 10°C~30°C. Unless otherwise specified, all reagents used are analytical
reagents. The experimental water shall meet the requirements for grade two
water specified in GB/T 6682.
4 Test method
4.1 Poloxamer
4.1.1 Gel chromatography
4.1.1.1 Test principle
Poloxamer is a polyoxyethylene polyoxypropylene ether block copolymer. It is
a class of polymer nonionic surfactants. The commonly used models in care
products are poloxamer 188 and poloxamer 407. This method uses a
b) Column temperature: 30°C;
c) Refractive index detector, temperature is 30°C;
d) Mobile phase: sodium dihydrogen phosphate solution (0.02mol/L):
acetonitrile=7:3;
e) Flow rate: 0.7mL/min;
f) Injection volume: 50μL.
4.1.1.7 Determination and result analysis
Respectively conduct analysis determination to standard solution and sample.
Establish standard working curve and regression equation. Calculate the
content of poloxamer in the sample. See Annex A for typical chromatograms.
4.1.2 Ultraviolet-visible spectrophotometry
4.1.2.1 Test principle
According to the characteristic that hydroxypropyl methylcellulose has the
ability to form a gel after heating in an aqueous solution, and then dissolve after
cooling, pre-process the care solution to remove HPMC. Use ultraviolet-visible
spectrophotometry that takes iodine-potassium iodide solution as the developer
to determine the poloxamer content in nursing solution in the care solution.
4.1.2.2 Instruments and reagents
4.1.2.2.1 Reagents: iodine, potassium iodide.
4.1.2.2.2 Reference substance: poloxamer.
4.1.2.2.3 Instruments: UV-visible spectrophotometer, 1cm quartz cuvette;
analytical balance with accuracy of 0.1mg.
4.1.2.3 Solution preparation
Poloxamer standard stock solution (0.1mg/mL): Accurately weigh 0.5g of
poloxamer for reference that has been dried to constant weight, to the nearest
of 0.1mg. Use pure water to conduct ultrasonic dissolution and set volume into
a 50mL volumetric flask. Shake well. Then accurately pipette 1mLof the above
solution to a 100mL volumetric flask. Use pure water to set volume to the scale.
Shake well to obtain the solution.
Iodine-potassium iodide color developing solution: Weigh 2.0g of potassium
iodide. Add an appropriate amount of water to make it dissolved. Then
accurately add 1.0g of iodine to make it dissolved. Transfer to a 100mL
analytical balance with accuracy of 0.1mg.
4.2.3 Solution preparation
Epoxyethylene hydrogenated castor oil standard stock solution (0.2mg/mL):
Weigh 0.1g of RH40 reference substance, to the nearest of 0.1mg. Use pure
water to dissolve. Set volume to a 50mL volumetric flask. Shake well. Then
accurately pipette 1mLof the above solution to a 10mL volumetric flask. Use
pure water to set volume to the scale. Shake well to obtain 0.2mg/mL standard
stock solution.
Iodine-potassium iodide color developing solution: Weigh 2.0g of potassium
iodide. Add an appropriate amount of water to make it dissolved. Then
accurately add 1.0g of iodine to make it dissolved. Transfer to a 100mL
volumetric flask. Add water to dilute to the scale. Shake well to obtain the
solution (this product shall be kept away from light).
4.2.4 Preparation of standard solution
Respectively pipette 1.0mL~3.0mL of epoxy ethylene hydrogenated castor oil
standard stock solution to 10mL volumetric flasks. Set volume and shake well.
Add 0.25mL of mixed color developing solution. Shake well to obtain a series
of standard solutions with a concentration of 20×10-6~60×10-6. At least 5
concentration points shall be selected. Use the same method and take pure
water for blank.
4.2.5 Sample processing
Precisely pipette the right amount of sample. Dilute to a concentration about
40×10-6. Then accurately add 0.25mL of iodine-potassium iodide color
developing solution. Shake well.
4.2.6 Determination and result analysis
After standard and sample are placed for 2h, at 500nm, determine the
absorbance. Perform parallel determination of 3 sets of data. Establish working
standard curve and regression equation. Calculate the content of epoxy
ethylene hydrogenated castor oil in the sample according to the standard curve.
5 Test report
The test report shall at least contain the following information:
a) Information about test sample;
b) Reference number to this Part;
...