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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 ForewordThis 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 quality1 ScopeThis 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 referencesThe 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 spectrophotometry3 Terms and definitionsThe 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 requirements4.1 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 5ForewordThis 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 quality1 ScopeThis 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 referencesThe 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 spectrophotometry3 Terms and definitionsThe 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 requirements4.1 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. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. |