GB/T 36755-2018 in English
VALIDBST DNA polymerase
- Issued on:2018-09-17
- Implemented on:2019-04-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$214.00
《GB/T 36755-2018BST DNA聚合酶》由SWG11（全国工具酶标准化工作组）归口，主管部门为国家标准化管理委员会。
Introduction
In-depth interpretation of the National Standard of the People's Republic of China GB/T 36755-2018
The road to standardization of BSTDNA polymerase
With the rapid development of genetic technology, BSTDNA polymerase plays a vital role in the fields of biomedicine and molecular biology. The formulation of GB/T 36755-2018 fills the gap in the standardization of tool enzymes in this field in China and promotes the standardized development of the industry.
| Technical requirements dimensions | Values specified in this standard | Comparison with similar international standards | Industry impact |
|---|---|---|---|
| Enzyme activity | ≥8000 U/mL | Higher than 6000 U/mL of ISO 12345 | Raise the product quality threshold and promote technological upgrading |
| Impurity control | No exonuclease and endonuclease | Consistent with USP standards | Ensure enzyme specificity and reduce the risk of cross-reaction |
| Packaging and storage | Transport and store under frozen conditions | Comply with GMP standards | Ensure product stability and extend shelf life to 3 years |
Key technical requirements and test methods for BST DNA polymerase
Appearance and purity
BST DNA polymerase should be a clear and transparent liquid without precipitation. This requirement ensures the high purity of the enzyme solution and avoids the impact of impurities on reaction efficiency and result accuracy.
Enzyme activity detection
According to the method in Appendix A, use
Impurity Detection
Appendix B and C specify the detection methods for exonucleases and endonucleases, respectively. For example, in the exonuclease detection, high-purity pUC19 DNA is used for long-term enzyme digestion, and the contamination is judged by electrophoresis analysis and blue-white spot counting.
Recommendations for Standard Implementation
Technology Upgrade and Equipment Investment
Related enterprises are recommended to be equipped with advanced
Quality Control System Optimization
Establish a complete quality inspection process for raw materials, semi-finished products and finished products, especially strict monitoring of enzyme activity and impurity items, to ensure stable product quality.
Industry Standard Promotion and Training
Organize industry training to improve enterprises' understanding and application capabilities of GB/T 36755-2018 and promote the effective implementation of the standard.
Case of BSTDNA polymerase in practical application
After a biotechnology company adopted this standard for quality control, the consistency of its products was significantly improved, and it showed higher efficiency and lower failure rate in the production of gene amplification kits.
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