{"id":291283,"date":"2024-10-19T19:46:40","date_gmt":"2024-10-19T19:46:40","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-iso-20688-12020\/"},"modified":"2024-10-25T16:48:18","modified_gmt":"2024-10-25T16:48:18","slug":"bs-iso-20688-12020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-iso-20688-12020\/","title":{"rendered":"BS ISO 20688-1:2020"},"content":{"rendered":"
This document specifies minimum requirements for the production and quality control of synthesized oligonucleotides (nominally up to 250 bases).<\/p>\n
This document also describes general quality attributes for synthesized oligonucleotides as well as common methods for evaluating quality attributes.<\/p>\n
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
---|---|---|---|---|---|---|---|
2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
6<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
7<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
9<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
10<\/td>\n | 4 Design and selection of suitable oligonucleotides that are fit for purpose 5 General quality management requirements 5.1 General requirements <\/td>\n<\/tr>\n | ||||||
11<\/td>\n | 5.2 Oligonucleotide grading 5.3 Control of documents 5.4 Quality management system 5.5 Personnel and training 5.6 Safety control 6 \u200bResource management <\/td>\n<\/tr>\n | ||||||
12<\/td>\n | 7 Requirements for production process 7.1 General 7.2 Oligonucleotide synthesis 7.3 Purification 7.4 Quality control inspection <\/td>\n<\/tr>\n | ||||||
13<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
14<\/td>\n | 8.3.3 Impurity 8.4 Quantity 8.4.1 General 8.4.2 Concentration <\/td>\n<\/tr>\n | ||||||
15<\/td>\n | 8.4.3 Mass 8.5 Molar mass and\/or base length <\/td>\n<\/tr>\n | ||||||
16<\/td>\n | 8.6 Melting temperature (Tm) 8.7 Report <\/td>\n<\/tr>\n | ||||||
17<\/td>\n | 8.8 \u200bVerification of corrective action and improvements 9 Additional requirements for synthetic oligoribonucleotides (RNA) <\/td>\n<\/tr>\n | ||||||
18<\/td>\n | Annex A (informative) Process checklist <\/td>\n<\/tr>\n | ||||||
20<\/td>\n | Annex B (informative) List of equipment and devices and their control standards <\/td>\n<\/tr>\n | ||||||
22<\/td>\n | Annex C (informative) Calculation of molar mass and molar numbers <\/td>\n<\/tr>\n | ||||||
25<\/td>\n | Annex D (informative) Verification of oligonucleotide sequences using mass analysis <\/td>\n<\/tr>\n | ||||||
31<\/td>\n | Annex E (informative) Accuracy control of measurement instrument with certified reference materials \u2014 Examples <\/td>\n<\/tr>\n | ||||||
34<\/td>\n | Annex F (informative) Calculation method of Tm values <\/td>\n<\/tr>\n | ||||||
36<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Biotechnology. Nucleic acid synthesis – Requirements for the production and quality control of synthesized oligonucleotides<\/b><\/p>\n |