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YY/T 1550.1-2017 PDF in English

YY/T 1550.1-2017 (YY/T1550.1-2017, YYT 1550.1-2017, YYT1550.1-2017)
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Standards related to: YY/T 1550.1-2017

YY/T 1550.1-2017: PDF in English (YYT 1550.1-2017)

YY/T 1550.1-2017
ICS 11.040.30
C 31
Guidance of study on the compatibility of
infusion equipment and pharmaceutical products -
Part 1. Drug sorption
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 
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
3 Terms and definitions
The following terms and definitions apply to this document.
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.
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. 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. 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. 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. Linearity
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.