YY/T 1695-2020Medical devices for human assisted reproductive technology—Determination of amino acids in human assisted reproductive media (English PDF)
人类辅助生殖技术用医疗器械 培养用液中氨基酸检测方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 31, 2020
Implementation date
April 1, 2021
Scope
YY/T 1695-2020 is the English-translated version of 人类辅助生殖技术用医疗器械 培养用液中氨基酸检测方法.
YY/T 1695-2020 is the Chinese pharmaceutical industry standard that gives the methods for determining the amino acid composition of the culture media used in human assisted reproduction: the amino acid analyser, liquid chromatography with triple quadrupole mass spectrometry, and liquid chromatography with pre-column derivatization.
It sets out the reagents, the preparation of the sample, the chromatographic and detection conditions and the calculation, for the amino acids the media contain, among them glycine, leucine and methionine, so that the composition declared for a medium can be verified. It was issued on 31 March 2020 and has applied since 1 April 2021.
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Document preview — YY/T 1695-2020
National Standard of the People's Republic of China
- ICS
- 11.040.30
- Classification
- C 30
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the amino acid analyzer method, high performance liquid chromatography tandem triple quadrupole mass spectrometry method, and high performance liquid chromatography pre-column derivatization Method to detect the amino acid composition in the culture solution for human assisted reproductive technology.
This standard applies to glycine (GLY), leucine (LEU), and methionine contained in culture fluids for human assisted reproductive technology (MET), Tyrosine (TYR), Histidine (HIS), Threonine (THR), Alanine (ALA), Isoleucine (ILE), Tryptophan (TRY), cystine (CYS), lysine (LYS), aspartic acid (ASP), valine (VAL), phenylalanine (PHE), proline (PRO), serine (SER), glutamic acid (GLU), arginine (ARG), taurine (TAU) quantitative analysis of 19 amino acids.
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 the cited documents without date, the latest version (including all amendments) applies to this document.
GB/T 6682 Analysis laboratory water specifications and test methods JJG 1064-2011 Verification Regulation of Amino Acid Analyzer
YY/T 0995 Terms and definitions of medical devices for human assisted reproductive technology
3 Terms and definitions
The terms and definitions defined in YY/T 0995 and the following apply to this document.
3.1 Aminoacidanalyzer
The ion exchange chromatography column in the amino acid analyzer separates the different amino acids in the sample, and derivatizes with ninhydrin as the column.
Measured at 570nm and 440nm wavelengths, quantified by external standard method.
3.2 High performance
liquid chromatography tandem triple quadrupole mass spectrometry high-performanceliquidchromatographycoupledtotan- demmassspectrometry High performance liquid chromatography preliminarily separates the components to be tested in the sample, and the triple quadrupole mass spectrometer passes the separated components The ion-mass-nucleus ratio obtains the ions to be measured, and the ions to be tested are broken into product ions after collision, and finally the quantification of the ions to be measured by the product ion ingredient.
3.3 High-performance liquid chromatography pre-column derivatization and high-performance liquid chromatography analysismethod
The component to be tested is first converted into a derivatized product through a derivatization reaction, and then separated from other components in the sample Quantification by external standard method.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.
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Related Standards
GB/T 6682-2008 — Water for analytical laboratory use - Specification and test methods
YY/T 0995-2015 — Medical devices for human assisted reproductive technology—Terminology and definitions
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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