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YY/T 0719.9-2021 English PDF

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YY/T 0719.9-2021: (Ophthalmic optics-Contact lens care products - Part 9: Chelating agent determination method)
Status: Valid
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YY/T 0719.9-2021English139 Add to Cart 3 days [Need to translate] (Ophthalmic optics-Contact lens care products - Part 9: Chelating agent determination method) Valid YY/T 0719.9-2021

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Basic data

Standard ID YY/T 0719.9-2021 (YY/T0719.9-2021)
Description (Translated English) (Ophthalmic optics-Contact lens care products - Part 9: Chelating agent determination method)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C40
Word Count Estimation 6,664
Issuing agency(ies) State Drug Administration

YY/T 0719.9-2021: (Ophthalmic optics-Contact lens care products - Part 9: Chelating agent determination method)


---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
(Ophthalmic optics-Contact lens care products-Part 9.Chelating agent determination method) ICS 11.040.70 C40 People's Republic of China Pharmaceutical Industry Standard Ophthalmic Contact Lens Care Products Part 9.Methods for the determination of chelating agents Published on 2021-09-06 2022-09-01 Implementation Released by the State Drug Administration

foreword

YY/T 0719 "Ophthalmic Optical Contact Lens Care Products" is divided into 11 parts. --- Part 1.Terminology; --- Part 2.Basic requirements; --- Part 3.Microbiological requirements and test methods and contact lens care systems; --- Part 4.Guidelines for testing the effectiveness of antimicrobial preservatives and determining the date of disposal; --- Part 5.Determination of physical compatibility of contact lenses and contact lens care products; --- Part 6.Guidelines for Determination of Validity Period; --- Part 7.Guidelines for Biological Evaluation; --- Part 8.Determination of cleaning agents; --- Part 9.Determination of chelating agents; --- Part 10.Determination of disinfectants; --- Part 11.Determination of moisturizing lubricants. This part is part 9 of YY/T 0719. This section is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents. This part is proposed by the State Drug Administration. This part is under the jurisdiction of the National Medical Optical and Instrument Standardization Subcommittee (SAC/TC103/SC1). This section is drafted by. Zhejiang Institute of Medical Device Inspection. The main drafters of this section. Han Yin, Zhang Li, Qian Wenwen, Bao Jiaohui, Xu Pinghua, Chen Jingyun, Zhou Jun. Ophthalmic Contact Lens Care Products Part 9.Methods for the determination of chelating agents

1 Scope

This part of YY/T 0719 specifies that the active ingredient chelating agent in contact lens care products (referred to as care products) is ethylenediaminetetraacetic acid. Test method for the determination of disodium content. This section applies to contact lens care products containing disodium EDTA as the active ingredient of chelating agent.

2 Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document. GB/T 6682 Analysis Laboratory Water Specifications and Test Methods

3 General

The test methods specified in this section shall be carried out at room temperature of 10°C to 30°C. Unless otherwise specified, the reagents used should be of analytical grade. The water used shall meet the requirements of secondary water specified in GB/T 6682.

4 Test methods

4.1 Liquid chromatography 4.1.1 Test principle Liquid chromatography can exclude the interference of other functional components, and is used to determine the concentration of disodium EDTA in nursing products as a contact lens. Methods for quality control of active ingredients of chelating agents in care products. This method can be used as an arbitration method. Any liquid chromatography analysis conditions not recommended in this section can be used as long as the analysis is proven reliable. 4.1.2 Instruments and Reagents The experimental water should meet the requirements of first-class water specified in GB/T 6682. 4.1.2.1 Reagents Sodium nitrate, ferric nitrate nonahydrate, acetic acid (chromatographic grade). 4.1.2.2 Reference substance Disodium EDTA standard substance or standard solution. 4.1.2.3 Instrumentation High performance liquid chromatograph (including pump module, online vacuum degasser, UV detector, column oven, automatic sampler, chromatography workstation);

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