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YY/T 1550.1-2017 English PDF (YYT1550.1-2017)

YY/T 1550.1-2017 English PDF (YYT1550.1-2017)

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YY/T 1550.1-2017: Guidance of study on the compatibility of infusion equipments and pharmaceutical products—Part 1: Drug sorption
This part of YY/T 1550 gives the study method of drug sorption during the process of contacting the single-use infusion device with drugs under the conditions of simulated clinical infusion or clinical actual infusion conditions. This part applies to the study of drug sorption in the compatibility study between a specific infusion device and the drug to be infused or the typical drug selected after demonstration.
YY/T 1550.1-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.30
C 31
Guidance of study on the compatibility of
infusion equipment and pharmaceutical products -
Part 1. Drug sorption
ISSUED ON. FEBRUARY 28, 2017
IMPLEMENTED ON. JANUARY 01, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword . 3
Introduction .. 4
1 Scope .. 5
2 Normative references . 5
3 Terms and definitions . 5
4 Test methods .. 6
5 Study report content . 8
Introduction
The compatibility study of infusion equipment and pharmaceutical products includes the study of drug sorption by equipment in the infusion process, and the study of leachable substances in the migration from equipment to drugs. This part only deals with drug sorption studies for infusion equipment. Guidelines for the study of leachable substance migrated from the equipment to the drugs will be given elsewhere in this series of standards.
Intravenous infusion is a unique method of drug provision that directly enters the body's blood circulatory system without passing through any biological barrier. The sorption of drugs on infusion equipment during clinical use will directly affect the therapeutic effect of drugs, i.e., effectiveness, especially for low-dose drugs. In addition, some treatments that require precise drug delivery, such as insulin or some highly toxic drugs, if sorption and desorption action occur in the infusion process, can cause doses at some time points to exceed the expected dose. Therefore, it is of great significance to establish and formulate guidelines for the study of the compatibility of drugs and devices, and to scientifically and standardly evaluate the compatibility of devices and drugs in drug delivery process.
Due to the wide variety of infusion drugs and the great differences in the clinical application of different infusion equipment, it is not possible to present a test method that is applicable to the compatibility study of all drugs and infusion equipment. When conducting drug compatibility studies of specific drugs and infusion devices, reference may be made to the method given in YY/T 1550, and other test methods with sufficient precision, accuracy, linearity, and sensitivity may also be selected.
Guidance of study on the compatibility of
infusion equipment and pharmaceutical products -
Part 1. Drug sorption
1 Scope
This part of YY/T 1550 gives the study method of drug sorption during the process of contacting the single-use infusion device with drugs under the conditions of simulated clinical infusion or clinical actual infusion conditions. This part applies to the study of drug sorption in the compatibility study between a specific infusion device and the drug to be infused or the typical drug selected after demonstration.
2 Normative references
The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this standard.
GB/T 6682 Water for analytical laboratory use - Specification and test
methods
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Drug compatibility
The evidence of no serious interactions between the infusion set and the drug that leads to changes in efficacy and stability or to toxicological risk. 3.2
Sorption
Sorption studies typically characterize changes in drug efficacy by measuring changes in drug concentration in infusion solution. For some treatment
processes that require precise drug delivery, such as insulin or certain highly toxic drugs, it is advisable to consider determining the appropriate sampling time point to examine the sorption and desorption of the drug by infusion devices at different time points.
4.2.1 Methodology study item
It should use the confirmed test methods to determine drug concentration changes in drug components in infusion solution. Generally, priority is given to the determination method of the drug content in the drug preparations to be studied. The commonly used drug content analysis methods include high
performance liquid chromatography (HPLC), gas chromatography (GC or
GC/MS), visible UV spectrophotometry (Vis-UV), and the like. The proposed method for concentration determination shall consider at least the following relevant methodological study items.
4.2.1.1 Specific properties
The auxiliary ingredient, related substances in the pharmaceutical preparations, infusion carriers during the preparation of the extracts, and potential leachable substances in the infusion instruments shall not interfere with the determination of the drug content. It should use appropriate methods to verify the specificity of the method to be used for determination of the content. For example, when the HPLC method is used to determine the drug content, the separation study of the system suitability test, the comparation of solution chromatogram of infusion carrier passing through the infusion device before and after adding the drug preparations.
4.2.1.2 Precision
It should use appropriate methods to examine the precision of the method to be used for determination of the content, for example, the same test solution is determined continuously for not less than 6 times, and the relative standard deviation (RSD) is calculated.
4.2.1.3 Stability
The change in drug concentration of the drug control solution is determined at least before and at the end of the experiment, to confirm the stability of the drug control solution itself that has not been in contact with the infusion set throughout the entire test period.
4.2.1.4 Linearity
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