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Protein A affinity chromatographic medium
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Basic data
| Standard ID | GB/T 38172-2019 (GB/T38172-2019) |
| Description (Translated English) | Protein A affinity chromatographic medium |
| Sector / Industry | National Standard (Recommended) |
| Classification of Chinese Standard | A21 |
| Classification of International Standard | 07.080 |
| Word Count Estimation | 10,174 |
| Date of Issue | 2019-10-18 |
| Date of Implementation | 2019-10-18 |
| Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration |
GB/T 38172-2019: Protein A affinity chromatographic medium
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Protein A affinity chromatographic medium
ICS 07.080
A21
National Standards of People's Republic of China
Protein A affinity chromatography medium
Published on.2019-10-18
2019-10-18 implementation
State market supervision and administration
China National Standardization Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard was proposed and managed by the China National Institute of Standardization.
This standard was drafted. Institute of Process Engineering, Chinese Academy of Sciences, China National Institute of Standardization, Zhongke Senhui Microsphere Technology (Suzhou) Limited
the company.
The main drafters of this standard. Huang Yongdong, Zhao Wei, Zhu Kai, Wu Xuexing, Ma Guanghui, Su Zhiguo, Gong Fangling, Ma Aijin, Yang Weixing, Wang Shaoyun,
Qin Jia.
Protein A affinity chromatography medium
1 Scope
This standard specifies the technical requirements, testing methods, inspection rules, labels, signs, packaging, transportation and
Storage.
This standard applies to the production and detection of protein A affinity chromatography media.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 packaging storage and transportation icon
GB/T 5475 ion exchange resin sampling method
GB/T 6682 Analytical laboratory water specifications and test methods
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Recombinant Protein A was coupled to a type of chromatographic medium prepared on an agarose separation medium.
4 Technical requirements
4.1 Appearance requirements
Protein A affinity chromatography media should be spherically full and smooth, and should be transparent under an optical microscope.
4.2 Performance requirements
Should meet the requirements in Table 1.
Table 1 Main performance requirements of protein A affinity chromatography media
Project indicator
Particle size
Range particle size ratio (W particle size) /% ≥90a
Average particle size (d)/μm 90.0 ± 13.5
The highest flow rate b/(cm/h) ≥ 300
Ligand density (ρ)/(mg/mL) 4 ~ 8
Dynamic load (Q10%) c/(mg/mL) > 40
...
