YY/T 1416.5-2021Test method for additive in single-use containers for human venous blood specimen collection - Part 5: Glycine (English PDF)
一次性使用人体静脉血样采集容器中添加剂量的测定方法 第5部分：甘氨酸
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 9, 2021
Implementation date
April 1, 2022
Scope
YY/T 1416.5-2021 is the English-translated version of 一次性使用人体静脉血样采集容器中添加剂量的测定方法 第5部分：甘氨酸.
YY/T 1416.5-2021 is the Chinese pharmaceutical industry standard that gives the method for determining the amount of glycine in a single-use venous blood collection container whose additive contains it.
It is the fifth part of the YY/T 1416 series on the testing of additives in such containers and sets out the reagents, the extraction of the additive from the container, the determination itself and the calculation of the dose per container, so that the amount actually present can be checked against what the label declares. Issued on 9 March 2021, it has applied since 1 April 2022.
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Document preview — YY/T 1416.5-2021
National Standard of the People's Republic of China
- Classification
- C 31
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Ninhydrin colorimetry
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.
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.
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 document. 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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 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 1416.6-2021 — Test method for additive in single-use containers for human venous blood specimen collection - Part 6: Imidazolidinyl urea
YY/T 1416.4-2016 — Test method for additive in single-use containers for human venous blood specimen collection - Part 4: Fluoride
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