BS ISO 20688-1:2020
$167.15
Biotechnology. Nucleic acid synthesis – Requirements for the production and quality control of synthesized oligonucleotides
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 38 |
This document specifies minimum requirements for the production and quality control of synthesized oligonucleotides (nominally up to 250 bases).
This document also describes general quality attributes for synthesized oligonucleotides as well as common methods for evaluating quality attributes.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 6 | Foreword |
| 7 | Introduction |
| 9 | 1 Scope 2 Normative references 3 Terms and definitions |
| 10 | 4 Design and selection of suitable oligonucleotides that are fit for purpose 5 General quality management requirements 5.1 General requirements |
| 11 | 5.2 Oligonucleotide grading 5.3 Control of documents 5.4 Quality management system 5.5 Personnel and training 5.6 Safety control 6 Resource management |
| 12 | 7 Requirements for production process 7.1 General 7.2 Oligonucleotide synthesis 7.3 Purification 7.4 Quality control inspection |
| 13 | 7.5 Drying 7.6 Formulation 8 Requirements for quality control process 8.1 General 8.2 Validation and verification of analytical methods 8.3 Identity and purity 8.3.1 Identity of the base sequence 8.3.2 Purity |
| 14 | 8.3.3 Impurity 8.4 Quantity 8.4.1 General 8.4.2 Concentration |
| 15 | 8.4.3 Mass 8.5 Molar mass and/or base length |
| 16 | 8.6 Melting temperature (Tm) 8.7 Report |
| 17 | 8.8 Verification of corrective action and improvements 9 Additional requirements for synthetic oligoribonucleotides (RNA) |
| 18 | Annex A (informative) Process checklist |
| 20 | Annex B (informative) List of equipment and devices and their control standards |
| 22 | Annex C (informative) Calculation of molar mass and molar numbers |
| 25 | Annex D (informative) Verification of oligonucleotide sequences using mass analysis |
| 31 | Annex E (informative) Accuracy control of measurement instrument with certified reference materials — Examples |
| 34 | Annex F (informative) Calculation method of Tm values |
| 36 | Bibliography |
