YY/T 1695-2020 in English

VALID

Medical devices for human assisted reproductive technology—Determination of amino acids in human assisted reproductive media

Issued on:2020-03-31
Implemented on:2021-04-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $220.00
$214.00

Standard No:	YY/T 1695-2020
Document status:	VALID
Title in English:	Medical devices for human assisted reproductive technology—Determination of amino acids in human assisted reproductive media
Title in Chinese:	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
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2020-03-31
Implemented on:	2021-04-01
Professional Classification:	YY-Pharmaceutics
Related Keywords:	human assisted reproductive technology assisted reproductive technology reproductive technology determination amino acids key amino acids
Related Topics:	Amino detection Amino Acid Mass Spectrometry Amino Acid Detection Amino detection method Amino detection Amino detection method Amino detection method Amino Acid Detection Mass Spectrometry for Amino Acids Mass Spectrometry for Amino Acids Amino detection method Medical Testing Technology reproductive technology colonization in medicine human reproductive technology Human Assisted Reproductive Technology human amino acid Amino acid detection method Amino acid detection method Common detection methods and principles of amino acids Detection method of aldehyde amino acids Blood culture testing methods Method for detecting arginine in human blood Tryptophan detection method non-derivatization Detection methods for amino acids in pharmaceuticals Heavy metal detection of Class I medical devices Arginine liquid phase detection method Methods for detecting histidine in drugs Construction of Assisted Medicine Reproductive Center Several commonly used methods for detecting amino acids Valine detection method Methods for artificially synthesizing amino acids Biochemical testing methods for medical devices How to detect leucine in blood What method is used to detect amino acids? Detection methods and principles of amino acids Serine detection method Beta-amino acid purity detection method Valine national standard detection method How to detect amino acids What are the detection methods for amino acids? Liquid ammonia detection Histidine liquid phase detection method Histidine detection method Various amino acid detection methods Class II medical device technology Common methods for detecting amino acids Statistical technical methods of farmed fish biomass Method for detecting the number of amino groups Methods for detecting amino acids in cells Medical device eye fluid testing Liquid culture medium inoculation method Methods for detecting amino acids Intracellular amino acid detection method Zhongke New Life's method for measuring amino acids Serine liquid chromatography detection method Measuring amino acids without derivatization Specific methods for glycine detection Artificial amino acid synthesis method Commonly used detection methods and principles of amino acids Amino acid detection method and principle Methods for detecting microorganisms in culture medium of Chinese Pharmacopoeia Amino Acid Detection Method yy/t1695-2020 Preparation method of ampicillin culture medium

本标准规定了用氨基酸分析仪法、高效液相色谱串联三重四极杆质谱仪法、高效液相色谱柱前衍生法检测人类辅助生殖技术用培养用液中氨基酸成分。
本标准适用于人类辅助生殖技术用培养用液中所含甘氨酸（GLY）、亮氨酸（LEU）、蛋氨酸（MET）、酪氨酸（TYR）、组氨酸（HIS）、苏氨酸（THR）、丙氨酸（ALA）、异亮氨酸（ILE）、色氨酸（TRY）、胱氨酸（CYS）、赖氨酸（LYS）、天门冬氨酸（ASP）、缬氨酸（VAL）、苯丙氨酸（PHE）、脯氨酸（PRO）、丝氨酸（SER）、谷氨酸（GLU）、精氨酸（ARG）、牛磺酸（TAU）19种氨基酸的定量分析。

Introduction

Analysis of the core content of the standard

This standard specifies the quantitative analysis method for 19 key amino acids in the culture medium used in human assisted reproductive technology, including three detection technology paths: amino acid analyzer, high performance liquid chromatography tandem triple quadrupole mass spectrometer and high performance liquid chromatography pre-column derivatization.

Comparative analysis of detection methods

Method type	Sensitivity (μg/mL)	Applicable scenarios	Technical features
Amino acid analyzer method (arbitration method)	1-100	Conventional detection	Ion exchange chromatography + post-column derivatization, not applicable to samples containing dipeptides
HPLC-MS/MS method	0.05-1	Trace analysis	Mass spectrometry qualitative and quantitative, mass spectrometry parameters need to be optimized
Pre-column derivatization method	1-100	Laboratories with limited equipment	OPA/FMOC derivatization, reaction conditions need to be controlled

Key technical points

1. Sample pretreatment specifications

Note for all methods: Protein precipitation is treated with 4% sulfosalicylic acid or acetonitrile, and the centrifugation speed is 9500g; the amino acid concentration needs to be adjusted to the linear range of each method.

2. Key indicators of quality control

Correlation coefficient of standard curve ≥0.995
Relative deviation of parallel samples ≤15-20%
Blank value must be lower than the detection limit
Separation degree of amino acid analyzer method ≥85%

Implementation suggestions

Guide to laboratory method selection

1. Arbitration detection: amino acid analyzer method is preferred, and attention should be paid to avoiding dipeptide interference
2. Scientific research analysis: HPLC-MS/MS method is recommended, which can simultaneously obtain mass spectrometry qualitative information
3. Routine monitoring: pre-column derivatization method has lower cost, and derivatization reaction time needs to be strictly controlled

Standard application precautions

• Tryptophan requires special treatment: add NaOH to aid dissolution
• Pay attention to the differences between methods when testing cystine
• Mass spectrometry requires regular mass number calibration (deviation ≤ 0.5Da)

Background of standard evolution

With the development of assisted reproductive technology, the requirements for the control of culture medium components are constantly increasing. This standard systematically regulates the detection methods of 19 amino acids for the first time, including:
• HPLC-MS/MS method reflects the latest development of detection technology
• Pre-column derivatization method retains the applicability of traditional methods
• Clarifies the arbitration method to ensure the resolution of disputed results

More samples: YD/T 3934-2021 JC/T 2453-2018 NB/T 47013.2-2015

Sample only — not a preview of YY/T 1695-2020

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