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General assessment of quality evaluation for synthesized genes
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Basic data
| Standard ID | GB/T 37873-2019 (GB/T37873-2019) |
| Description (Translated English) | General assessment of quality evaluation for synthesized genes |
| Sector / Industry | National Standard (Recommended) |
| Classification of Chinese Standard | G30 |
| Classification of International Standard | 03.120 |
| Word Count Estimation | 10,168 |
| Date of Issue | 2019-08-30 |
| Date of Implementation | 2019-08-30 |
| Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration |
GB/T 37873-2019: General assessment of quality evaluation for synthesized genes
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT37873-2019
(General rules for the evaluation of synthetic gene quality)
ICS 03.120
G30
National Standards of People's Republic of China
General rules for the evaluation of synthetic gene quality
Generalassessmentofqualityevaluationforsynthesizedgenes
Published on.2019-08-30
2019-08-30 implementation
State market supervision and administration
China National Standardization Administration issued
Content
Foreword III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Quality requirements 1
4.1 General 1
4.2 Purity 1
4.3 Total 1
4.4 Integrity 2
4.5 Sequence Consistency 2
5 Evaluation method 2
5.1 Samples and Reagents 2
5.2 Purity detection 2
5.3 Total amount detection 2
5.4 Integrity Detection 3
5.5 Sequence Consistency Detection 3
Appendix A (informative) Synthetic gene electrophoresis Figure 4
Appendix B (informative) Agarose gel electrophoresis detection method 5
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard is proposed and managed by the National Standards Research Center.
This standard was drafted. Shenzhen Huada Life Science Research Institute (formerly Shenzhen Huada Gene Research Institute), China Institute of Metrology, Shenzhen
Huada Gene Technology Co., Ltd., Qingdao Huada Gene Research Institute.
The main drafters of this standard. Wang Yun, Wang Jing, Shen Yi, Fu Boqiang, Zhao Hongcui, Gong Jianhui, Chen Tai, Liu Xin, Du Jiating, Xie Qiang, Niu Chunyan.
General rules for the evaluation of synthetic gene quality
1 Scope
This standard specifies the terms and definitions of synthetic genes, quality requirements, and evaluation methods.
This standard applies to the quality evaluation of synthetic genes (100bp ~ 20kb) based on biochemical synthesis.
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 34796-2017 Determination of the concentration and purity of nucleic acids in aqueous solutions - UV spectrophotometry
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Synthetic gene
A double-stranded DNA artificially synthesized according to a defined nucleotide sequence by a biochemical method.
3.2
DNA sequencing DNAsequencing
The determination of the nucleotide arrangement order of the DNA molecules, that is, the order of arrangement of A, T, G, and C constituting the DNA molecules. often
The methods used are the Sanger-Cousson method and the Marksam-Gilbert method.
[JJF1265-2010, definition 5.17]
3.3
Sequence alignment sequence alignment
The process of comparing the similarities between two or more nucleotide or amino acid sequences.
[GB/T 29859-2013, definition 2.2.1]
4 Quality requirements
4.1 General
The DNA sequence of the synthetic gene, in accordance with the requirements of the International Gene Synthesis Alliance (IGSC) biosafety requirements, including its quality requirements, including
DNA purity, total, integrity and sequence identity.
4.2 Purity
Under the condition of pH 7.0~8.5, the ratio of OD260/OD280 is between 1.8 and 2.0, and OD260/OD230≥2.0, in line with
Requirements of 8.3.2 of GB/T 34796-2017.
4.3 Total
The total quality of synthetic DNA is not lower than the customer's needs. Generally not less than 1 μg.
GB/T 37873-2019
(General rules for the evaluation of synthetic gene quality)
ICS 03.120
G30
National Standards of People's Republic of China
General rules for the evaluation of synthetic gene quality
Generalassessmentofqualityevaluationforsynthesizedgenes
Published on.2019-08-30
2019-08-30 implementation
State market supervision and administration
China National Standardization Administration issued
Content
Foreword III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Quality requirements 1
4.1 General 1
4.2 Purity 1
4.3 Total 1
4.4 Integrity 2
4.5 Sequence Consistency 2
5 Evaluation method 2
5.1 Samples and Reagents 2
5.2 Purity detection 2
5.3 Total amount detection 2
5.4 Integrity Detection 3
5.5 Sequence Consistency Detection 3
Appendix A (informative) Synthetic gene electrophoresis Figure 4
Appendix B (informative) Agarose gel electrophoresis detection method 5
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard is proposed and managed by the National Standards Research Center.
This standard was drafted. Shenzhen Huada Life Science Research Institute (formerly Shenzhen Huada Gene Research Institute), China Institute of Metrology, Shenzhen
Huada Gene Technology Co., Ltd., Qingdao Huada Gene Research Institute.
The main drafters of this standard. Wang Yun, Wang Jing, Shen Yi, Fu Boqiang, Zhao Hongcui, Gong Jianhui, Chen Tai, Liu Xin, Du Jiating, Xie Qiang, Niu Chunyan.
General rules for the evaluation of synthetic gene quality
1 Scope
This standard specifies the terms and definitions of synthetic genes, quality requirements, and evaluation methods.
This standard applies to the quality evaluation of synthetic genes (100bp ~ 20kb) based on biochemical synthesis.
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 34796-2017 Determination of the concentration and purity of nucleic acids in aqueous solutions - UV spectrophotometry
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Synthetic gene
A double-stranded DNA artificially synthesized according to a defined nucleotide sequence by a biochemical method.
3.2
DNA sequencing DNAsequencing
The determination of the nucleotide arrangement order of the DNA molecules, that is, the order of arrangement of A, T, G, and C constituting the DNA molecules. often
The methods used are the Sanger-Cousson method and the Marksam-Gilbert method.
[JJF1265-2010, definition 5.17]
3.3
Sequence alignment sequence alignment
The process of comparing the similarities between two or more nucleotide or amino acid sequences.
[GB/T 29859-2013, definition 2.2.1]
4 Quality requirements
4.1 General
The DNA sequence of the synthetic gene, in accordance with the requirements of the International Gene Synthesis Alliance (IGSC) biosafety requirements, including its quality requirements, including
DNA purity, total, integrity and sequence identity.
4.2 Purity
Under the condition of pH 7.0~8.5, the ratio of OD260/OD280 is between 1.8 and 2.0, and OD260/OD230≥2.0, in line with
Requirements of 8.3.2 of GB/T 34796-2017.
4.3 Total
The total quality of synthetic DNA is not lower than the customer's needs. Generally not less than 1 μg.
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