YY 0793.3-2023 in English

VALID

Preparation and quality control of fluids for hemodialysis and related treatments - Part 3: Concentrates for hemodialysis and related treatments

Issued on:2023-06-20
Implemented on:2025-07-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $250.00
$243.00

Standard No:	YY 0793.3-2023
Document status:	VALID
Title in English:	Preparation and quality control of fluids for hemodialysis and related treatments - Part 3: Concentrates for hemodialysis and related treatments
Title in Chinese:	血液透析和相关治疗用液体的制备和质量管理第3部分：血液透析和相关治疗用浓缩物
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2023-06-20
Implemented on:	2025-07-01
Superseding:	YY 0598-2015 Concentrates for haemodialysis and related therapies
Professional Classification:	YY-Pharmaceutics
Related Keywords:	solute concentration control quality control infection endotoxin control detection quality control chemical raw particle control
Related Topics:	blood hemodialysis treat standard of care Mass Spectrometry and Liquid Chromatography Preparative liquid phase Liquid phase preparation instrument Naphthalene liquid phase analysis Liquid phase preparation instrument HPLC Dialysis Preparative Liquid Analysis Liquid phase analysis salt liquid serum serum liquid phase Liquid phase semi-preparation Preparative liquid phase Preparative liquid phase analysis Preparation of liquid phase peaks solute concentration Liquid analysis content Liquid phase analyzer Liquid phase semi-preparation blood analysis c6 Preparative liquid phase Liquid Phase Analysis Liquid analysis peak Preparative liquid phase Semi-preparative liquid phase Analytical liquid phase Liquid Peak Concentration Analytical Liquid Phase Preparation blood substance blood flow analysis Animal blood analysis bulk of matter Liquid phase preparation c1 treatment and t treatment in english blood flow analysis Liquid analysis equipment Liquid analysis equipment blood analysis sheet Preparative liquid phase x2 Dialysis+ Liquid phase analyte blood coagulation phase liquid phase product peak liquid-liquid phase separation Preparative liquid phase semi-preparative semi-analytical liquid-phase preparative and semi-preparative analysis of liquid substances Relevant theoretical analysis How much is the correlation analysis Peptide Liquid Analysis liquid phase preparative liquid phase Quality analysis related Correlation coefficient liquid-liquid phase separation Liquid normal phase Preparative and analytical liquid phase Therapeutic Biological Products Class II Semi-analytical and semi-preparative liquid phase preparative liquid phase semi-preparative liquid phase High quality phase analysis liquid phase separator Guanidine liquid phase analysis liquid vapor tube Correlation coefficient analysis Liquid Phase Naphthalene Analysis preparative liquid second-hand Analytical liquid phase system gas tube liquid portable hemodialysis Preparative and semi-preparative liquid phase Hemodialysis machine multiple correlation analysis Correlation coefficient analysis blood part multiple correlation analysis Serial Autocorrelation Analysis Blood analysis 18 items Semi-preparative and preparative liquid phase flow cytometry blood Principle of Vapor-Liquid Phase Preparation and quality control of fluids for hemodialysis and related treatments The efficacy and role of Xuesaitong and its main treatments The difference between liquid phase and gas phase Liquid phase detection analysis sample loading Liquid phase internal standard Liquid phase related substances LQD and LOQ Liquid pipeline The difference between liquid phase and liquid quality Preparative liquid phase and semi-preparative liquid phase HPLC related substance integration Internal standard liquid phase analysis Medium pressure preparation of liquid mobile phases Technical testing and analysis related Blood analysis quality control industry Infusion line related Centralized concentrate supply system group for hemodialysis Principles and methods of preparing liquid phase Liquefied hydrocarbon management related Experimental methods for dialysis using snakeskin dialysis tubes Blood transfusion related industries Hemodialysis machine registration Liquid phase analysis method sample concentration Low and medium frequency treatment equipment related Blood bag related Liquid nitrogen related Hemodialysis tests Texture analysis related Reversed-phase liquid phase analytical method development

本文件规定了血液透析和相关治疗用浓缩物的技术要求。
本文件适用于血液透析和相关治疗用浓缩物。
本文件不适用于在透析液使用机构利用预包装的盐和水配制成的浓缩物以及透析液的再生系统。

Introduction

Core changes in the standard update

Technical indicators	YY 0598-2015	YY 0793.3-2023	Clinical significance
Microbial limits	Ungraded requirements	Aerobic bacteria ≤100CFU/mL Mold ≤10CFU/mL	Reduce the risk of infection
Endotoxin control	Detection method not specified	Endotoxin in dialysate <0.5EU/mL	Prevent pyrogenic reaction
Online B dry powder control	No special requirements	Added pH value and solute concentration detection	Ensure online preparation stability

Analysis of key technical requirements

Solute concentration control

The standard stipulates that the allowable deviation of sodium ion concentration is 97.5%-102.5% of the labeled amount, and other ions are controlled in the range of 95%-105%. The detection method shall give priority to the method of "Chinese Pharmacopoeia", among which:

Ion chromatography (arbitration method) is recommended for calcium/magnesium ions
Bicarbonate containing sodium acetate shall adopt the back titration method in Appendix E
Added liquid chromatography detection method for citrate

Implementation suggestions

Key points of quality control

Chemical raw and auxiliary materials must comply with the pharmacopoeia standards in Appendix D, with special attention to the special grade requirements of calcium chloride·2H₂O and sodium bicarbonate
Filters below 1μm shall be used for particle control, and the filter membrane material shall be recorded
Online B dry powder shall be verified by time gradient sampling (at least 4 time points)

Analysis of differences in international standards

Compared with ISO 23500-4:2019, the main adjustments include: deleting the additive clause, strengthening the pharmacopoeia test method, and adding special requirements for online B dry powder. These modifications are more in line with China's actual clinical application scenarios, such as:

Change the production water standard to reference YY 0572
Clarify that dialysis concentrate does not include a regeneration system
Add pH value as a mandatory test item

More samples: JGJ 94-2008 NB/T 47013.2-2015 JJG 21-2008

Sample only — not a preview of YY 0793.3-2023

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