YY/T 1639-2018Determination of residual of diphenylmethane diisocyanate(MDI)from thermoplastic polyurethane infusion equipments for single use (English PDF)
一次性使用聚氨酯输注器具二苯甲烷二异氰酸酯（MDI）残留量测定方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 20, 2018
Implementation date
January 1, 2020
Scope
YY/T 1639-2018 is the English-translated version of 一次性使用聚氨酯输注器具二苯甲烷二异氰酸酯（MDI）残留量测定方法.
YY/T 1639-2018 is the Chinese pharmaceutical industry standard that gives the high performance liquid chromatography method with fluorescence detection for determining residual diphenylmethane diisocyanate in single-use polyurethane infusion devices.
It sets out the reagents, the derivatization, the extraction of the device, the chromatographic conditions and the calculation of the residue, so that the limit set in the product standards can be checked. Issued on 20 December 2018, it has applied since 1 January 2020.
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Document preview — YY/T 1639-2018
National Standard of the People's Republic of China
- ICS
- 11.040.30
- 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 General
- 4 Determination method
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Introduction
Polyurethanes are generally prepared from polyether/polyester polyols, isocyanates, chain extenders, crosslinkers and minor amounts of auxiliaries. In disposable polyurethane Among the infusion devices, diphenylmethane diisocyanate (MDI) is the most common synthetic monomer. In production, MDI is first combined with polyol to form The soft segment prepolymer is polymerized to form polyurethane under the action of chain extender and other auxiliaries, and there may be free MDI residue in the process.
YY/T 1557-2017 "Special Materials for Thermoplastic Polyurethane for Medical Infusion, Blood Transfusion and Syringes" specifies medical infusion, blood transfusion, injection Technical requirements for thermoplastic polyurethane special materials (TPU) for appliances and components. Single use infusion device during clinical use The diversity and complexity of the medium being contacted may result in the migration of residual MDI, which poses a safety risk.
The standard uses high performance liquid chromatography-fluorescence method to determine the residual amount of MDI for disposable polyurethane infusion devices. High efficiency fluid can also be used Phase-mass spectrometry, high-performance liquid-ultraviolet and other suitable methods, but need to be verified by the necessary methodologies.
1 Scope
This standard gives high performance liquid chromatography-fluorescence method for the determination of diphenylmethane diisocyanate (MDI) residues in disposable polyurethane infusion devices. The amount of test method.
This standard applies to the determination of MDI residual content in disposable infusion devices using polyurethane as a material.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 6682 Analytical laboratory water specifications and test methods
3 General
3.1 The room temperature in this standard, if not specified, should be 10 ° C ~ 30 ° C.
3.2 The test water in this standard shall meet the requirements of GB/T 6682.
3.3 Containers used in this standard shall be borosilicate glass containers unless otherwise specified.
3.4 The measurement referred to in this standard shall be taken with a pipette that meets the accuracy requirements of the corresponding national standards.
4 Determination method
4.1 Principle
The sample was extracted with MDI from dichloromethane, and the MDI was derivatized with the derivatized reagent 9-N-methylaminomethyl hydrazine. The derivative was highly efficient.
The liquid chromatograph was used for the determination, and the retention time was used as a qualitative indicator, and the external standard method was used for quantification.
4.2 High Performance Liquid Chromatography
4.2.1 Instruments and reagents
4.2.1.1 Instruments
a) High performance liquid chromatography. equipped with a fluorescence detector;
b) Ultrasonic cleaner. operating frequency. 40kHz;
c) nitrogen blowing instrument;
d) pH meter;
e) Analyze the balance.
4.2.1.2 Reagents
a) dichloromethane, analytically pure;
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.
Referenced standards
Normative references
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