YY/T 0719.9-2021Ophthalmic optics - Contact lens care products - Part 9: Test method for chelator (English PDF)
眼科光学 接触镜护理产品 第9部分：螯合剂测定方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
September 6, 2021
Implementation date
September 1, 2022
Scope
YY/T 0719.9-2021 is the English-translated version of 眼科光学 接触镜护理产品 第9部分：螯合剂测定方法.
YY/T 0719.9-2021 is the Chinese pharmaceutical industry standard that gives the method for determining disodium EDTA, the chelating agent, in contact lens care products.
It is the ninth part of the YY/T 0719 series and sets out the reagents and the apparatus, the preparation of the sample and of the standards, the chromatographic determination and the calculation of the content, so that the declared amount of the active chelating ingredient can be checked.
It applies to care products that contain disodium EDTA. Issued on 6 September 2021, it has applied since 1 September 2022.
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Document preview — YY/T 0719.9-2021
National Standard of the People's Republic of China
- Classification
- C 40
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 General
- 4 Test methods
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.
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);
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 16 pages — is available in the English PDF.
Referenced standards
Normative references
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Related Standards
GB/T 6682-2008 — Water for analytical laboratory use - Specification and test methods
YY/T 0719.10-2022 — Ophthalmic optics - Contact lens care products - Part 10: Test method for lubricant
YY/T 0719.8-2019 — Ophthalmic optics - Contact lens care products - Part 8: Test method for detergent
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