Product Description
News:
1 monograph on General Methods of Analysis
6 monographs of critical Systems
1 monographs of Additives
14 Drug monographs
40 Pharmaceutical preparations monographs
4 Medical gases monographs
3 Biological products monographs
1 Monographs biotechnological products
Updates in relation to the previous edition and its Supplements 2015 and 2016:
Generalities; Impurities and Volumetric material
19 monographs on General Methods of Analysis
4 Solutions and reagents
4 Monographs of Critical systems
30 Monographs of Additives
24 Drug monographs
9 monographs medical gases
49 monographs Pharmaceutical Preparations
1 methods of Biological products
9 monographs on Biologics
16 monograph Biotechnological Products
Appendix II. Regulation related to the pharmaceutical industry
Appendix IV. Estimation of the uncertainty of pharmacopoeial analytical methods
Appendix V. General Principles of Good Laboratory Practices
Appendix VI. Conservation, maintenance and management of microbial cultures: seed lot system
Appendix VII. Microbiological analysis of non-sterile pharmaceutical products
Also in this edition the following exclusions were made:
2 General Methods of Analysis
1 Drug Monograph
2 Monographs of Pharmaceutical Preparations
2 Monographs of Biological Products
The chapter Radiopharmaceuticals is relocated to the Supplement for Medical Devices, fourth edition