GB/T 38172-2019 English PDF

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GB/T 38172-2019: Protein A affinity chromatographic medium
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 38172-2019	199	Add to Cart	3 days	Protein A affinity chromatographic medium	Valid

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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: 10,145
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 ......

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