GB/T 41907-2022 English PDF (GBT41907-2022)

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GB/T 41907-2022: Assay method of enterokinase activity
GB/T 41907-2022
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 07.080
CCS C 27
Assay method of enterokinase activity
ISSUED ON: OCTOBER 12, 2022
IMPLEMENTED ON: OCTOBER 12, 2022
Issued by: State Administration for Market Regulation;
Standardization Administration of the PRC.
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 5
4 Reagents or materials ... 5
5 Apparatus ... 6
6 Test procedure ... 6
7 Result calculation ... 7
8 Quality control ... 7
Foreword
This document is drafted in accordance with GB/T 1.1-2020 "Directives for
standardization - Part 1: Rules for the structure and drafting of standardizing
documents".
Attention is drawn to the possibility that some of the elements of this document may be
the subject of patent rights. The issuing authority of this document shall not be held
responsible for identifying any or all such patent rights.
This document was proposed by and shall be under the jurisdiction of National Tool
Enzyme Standardization Working Group (SAC/SWG 11).
Drafting organizations of this document: Leigu (Xiamen) Biomedicine Co., Ltd.;
General Biosystems (Anhui) Co., Ltd.; Suzhou Kunqi Biotechnology Co., Ltd.; Xiahe
(Shenzhen) Biotechnology Co., Ltd.; Xiamen Yinxiang Group Co., Ltd.; Xiamen Zhong
Ji Xin Testing Technology Co., Ltd.; Langfang Biotecnovo Medical Laboratory Co.,
Ltd.; Fujian Nansheng Technology Co., Ltd.; Shanghai Yingzi Life Technology Co.,
Ltd.; Suzhou Beaver Biomedical Engineering Co., Ltd.; Angel Yeast Co., Ltd.;
Shandong University; Fujian Agriculture and Forestry University; Fudan University;
Shanghai Chuyu Biotechnology Co., Ltd.; Division of Chemical Metrology and
Analytical Science, National Institute of Metrology, China; Shenzhen BGI Life Science
Research Institute.
Main drafters of this document: Huang Facan, Zheng Dengzhong, Yong Jingui, Zhao
Yi, Zhang Zhigang, Jiang Feng, Pang Tieliang, Zhu Li, Zhong Jiang, Yao Juan, Liu Bin,
Chen Xiulan, Ren Hui, Xing Zhigang, Zhao Chao, Quan Can, Zeng Feng, Zhang
Wenwei, Dong Yuliang, Xi Feng, Cheng Lei.
Assay method of enterokinase activity
1 Scope
This document describes the reagents or materials, apparatus, test procedure, result
calculation, and quality control for the assay method of enterokinase activity.
This document applies to the assay of enterokinase activity.
2 Normative references
The contents of the following documents, through normative references in this text,
constitute indispensable provisions of this document. Among them, for dated references,
only the edition corresponding to that date applies to this document. For undated
references, the latest edition (including all amendments) applies to this document.
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
Enterokinase
A proteolytic enzyme secreted by duodenal cells, which can cleave the lysine carboxy-
terminal peptide bond containing 4 aspartic acids (aspartic acid-aspartic acid-aspartic
acid-aspartic acid-lysine).
3.2
Activity unit of enterokinase (U)
The amount of enzyme - required to degrade 95% of 0.5 mg of Thioredoxin-NP-27 to
NP-27 within 16 h at 37 °C - is 1 activity unit of enterokinase (U).
4 Reagents or materials
Unless otherwise specified, the reagents used in this method shall be of analytical grade.
All reagent solutions should be prepared in large volumes; subpackaged in small
volumes and sterilized by autoclaving before use. Reagents that are not suitable for