YY/T 1416.6-2021Test method for additive in single-use containers for human venous blood specimen collection - Part 6: Imidazolidinyl urea (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6部分:咪唑烷基脲
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 9, 2021
Implementation date
April 1, 2022
Scope
YY/T 1416.6-2021 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6部分:咪唑烷基脲.
YY/T 1416.6-2021 is the Chinese pharmaceutical industry standard that gives the method for determining imidazolidinyl urea in the additive of a single-use venous blood collection container.
It is the sixth part of the YY/T 1416 series on the testing of such additives and sets out the reagents, the extraction of the additive from the container, the determination and the calculation of the amount per container, so that what the label declares can be verified.
It applies to collection containers whose additive contains imidazolidinyl urea, and the same method may be used for diazolidinyl urea, whose determination rests on the same principle. Issued on 9 March 2021, it has applied since 1 April 2022.
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Document preview — YY/T 1416.6-2021
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 Acetylacetone 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 6 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, also known as. blood collection container or blood collection tube, matched with disposable venous blood sample collection needle Used to collect venous blood samples for clinical testing. Collection containers containing different additives or add-ons have different uses, free deoxygenation The ribonucleic acid (DNA) preservation tube is a special-purpose collection container for non-invasive prenatal screening, early tumor screening and other clinical test samples Collection and storage of books. The storage quality of free DNA plays an important role in the test results. In the process of transportation and storage, it is necessary to prevent plasma The nuclease in the nuclease degrades free DNA, but also avoids the release of genomic DNA in blood nucleated cells. Therefore, save the tube by adding Nuclease inhibitors and nucleated cell protective agents are necessary. As a preservative, imidazolidinyl urea is mainly used to inhibit the growth of microorganisms.
Propagation and stabilization of nucleated blood cells, thereby preventing the release of cellular genomic DNA, inhibiting the nuclease-mediated degradation of cell-free DNA, and helping to prevent cell-free DNA from nuclease-mediated degradation. The overall stability of cell DNA.
This section gives the spectrophotometric method for the determination of the amount of imidazolidinyl urea in a single collection container. Other measurements can also be used. The method is determined, but methodological confirmation is required.
1 Scope
This part of YY/T 1416 provides a single-use human venous blood sample collection container (collection) for the determination of imidazolidinyl urea in additives.
The test method of the imidazolidinyl urea additive in the container). This section applies to collection containers containing imidazolidinyl urea additives.
Note. For diazoalkyl urea additives, because the detection principle is the same, you can refer to the method given in this section.
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 Acetylacetone colorimetry
3.1 Test principle
Condensed fragments of allantoin and formaldehyde exist in the aqueous solution of imidazolidinyl urea, which will decompose to release formaldehyde in Nash's reagent. formaldehyde In the near neutral mixture of acetylacetone and ammonium salt, a yellow product [3,5-diacetyl-1,4-dihydrolutidine (DDL)] is generated, The absorbance of the product at a wavelength of 412nm is directly proportional to the formaldehyde content. According to the absorbance of the test product, the free formaldehyde content of the test product is calculated This method uses the Hantzsch Reaction principle to determine the content of formaldehyde to calculate the content of imidazolidinyl urea.
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 412nm 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) Imidazolidinyl urea (purity >95%) standard stock solution. weigh a certain mass of imidazolidinyl urea (calculate the actual mass according to the purity), add Dissolve in water and dilute to a certain volume, and prepare 16mg/mL (or an appropriate concentration that meets the requirements of the standard curve) imidazolidinyl urea Standard stock solution;
b) Acetylacetone color developing solution. Weigh 15g of ammonium acetate, add an appropriate amount of water to dissolve, then add 0.3mL of acetic acid and 0.2mL of acetylacetone, shake Evenly, dilute to 100mL with water. Store at room temperature and avoid light, and use within 12h~24h after preparation (see ``People's Republic of China The second method of the 3207 free formaldehyde determination method "The preparation method of the acetylacetone colorimetric method").
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 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 1416.5-2021 — Test method for additive in single-use containers for human venous blood specimen collection - Part 5: Glycine
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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