YY/T 1416.5-2021 English PDF

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YY/T 1416.5-2021: Test method for additive in single-use containers for human venous blood specimen collection - Part 5: Glycine
Status: Valid

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YY/T 1416.5-2021	99	Add to Cart	3 days	Test method for additive in single-use containers for human venous blood specimen collection - Part 5: Glycine	Valid

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YY/T 1416.1   YY/T 1469   YY/T 1416.2   YY 1001   YY/T 1416.6   YY/T 1416.4   

Basic data

Standard ID: YY/T 1416.5-2021 (YY/T1416.5-2021)
Description (Translated English): Test method for additive in single-use containers for human venous blood specimen collection - Part 5: Glycine
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C31
Word Count Estimation: 5,549
Issuing agency(ies): State Drug Administration

YY/T 1416.5-2021: Test method for additive in single-use containers for human venous blood specimen collection - Part 5: Glycine

---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.
Test method for additive in single-use containers for human venous blood specimen collection - Part 5.Glycine ICS 11.040.30 C31 People's Republic of China Pharmaceutical Industry Standards Disposable human venous blood sample collection container Determination method of additive dose Part 5.Glycine Released on 2021-03-09 2022-04-01 implementation Issued by the National Medical Products Administration

Foreword

YY/T 1416 "Method for Determination of Additive Dose in Disposable Human Venous Blood Sample Collection Containers", which consists of the following parts. ---Part 1.Ethylenediaminetetraacetic acid (EDTA) salt; ---Part 2.Sodium Citrate; ---Part 3.Heparin; ---Part 4.Fluoride; ---Part 5.Glycine; ---Part 6.Imidazolidinyl urea; This part is part 5 of YY/T 1416. This section was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents. This part was proposed by the State Drug Administration. This part is under the jurisdiction of the National Standardization Technical Committee for Medical Infusion Devices (SAC/TC106). Drafting organizations of this section. China Institute for Food and Drug Control, Jiangsu Kangwei Century Biotechnology Co., Ltd., Shandong Medical Device Manufacturing Co., Ltd. Quality Inspection Center, Guangzhou Yangpu Medical Technology Co., Ltd. The main drafters of this section. Wang Yumei, Su Lihong, Yin Jianfeng, Du Fuying, Wang Chunren, Sun Bangfu.

Introduction

Disposable human venous blood sample collection container (collection container), also known as. blood collection container or blood collection tube, and disposable venous blood sample The collection needle is used as a set for collecting venous blood samples for clinical examination. The use of collection containers with different additives or additions is different At the same time, the free deoxyribonucleic acid (DNA) preservation tube is a special-purpose collection container for non-invasive prenatal screening, early tumor screening, etc. Collection and storage of clinical test samples. Glycine has a protective effect on cell adenine nucleoside triphosphate (ATP) depletion damage, often used It is a blood cell protective agent used in free DNA storage tubes to prevent blood cells from rupturing and releasing the genome and polluting circulating blood. From DNA. This section gives the ninhydrin method for the determination of glycine dosage in a single collection container. Other measurement methods can also be used, However, methodological confirmation is required. Disposable human venous blood sample collection container Determination method of additive dose Part 5.Glycine

1 Scope

This part of YY/T 1416 gives a single-use human venous blood sample collection container (collection container) containing glycine in the additive The test method for the dosage of glycine. This section applies to collection containers containing glycine additives.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document. GB/T 6682 Analytical laboratory water specifications and test methods

3 Ninhydrin colorimetry

3.1 Test principle Glycine can interact with ninhydrin in acidic solution to produce a blue-violet compound, which can be determined by absorbance photometry. The blue-violet compound The depth is proportional to the glycine content, and its maximum absorption wavelength is 570nm, so the glycine content in the sample can be determined based on this. 3.2 Apparatus and reagents 3.2.1 Apparatus The instruments used in the test are as follows. a) Electronic balance with an accuracy of 0.1mg; b) Spectrophotometer (or microplate reader with 570nm band). 3.2.2 Reagents Unless otherwise specified, the reagents used should be analytically pure, and the test water should meet the requirements of secondary water specified in GB/T 6682.among them. a) Glycine standard stock solution (10mmol/L). Weigh 75mg of glycine standard product in a 100mL volumetric flask, add water to dissolve and Volume; b) Ninhydrin solution. Weigh 4g of ninhydrin (or an equivalent amount of ninhydrin) and dissolve in 95mL of propylene glycol methyl ether. After dissolving, add 8.1mg sodium borohydride (addition according to storage time), stir to dissolve and filter, add propylene glycol methyl ether to make the volume to 100mL, stir evenly spare; Note. Adding reducing agents such as sodium borohydride, ascorbic acid or stannous chloride is to prevent the oxidation of the ninhydrin solution. If the prepared solution is ready-to-use, it is not necessary to add In; it needs to be added if stored overnight. c) Buffer solution. 401 mL of propylene glycol methyl ether, 123 mL of glacial acetic acid, 338.4 g of sodium acetate trihydrate, and dilute to 1000 mL with water. ......

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