Pharmaceutical analytics
The Pharmaceutical analysis is a branch of pharmaceutical chemistry and is concerned with the study (analysis) of pharmaceuticals and drugs . In addition to purely chemical analysis methods, it also includes physico-chemical and biochemical processes.
Pharmaceutical analysis methods are used to check the identity and purity of starting materials for drug production (drugs, auxiliary materials , primary packaging ), to examine the structure of substances used in pharmaceuticals, and to test drugs for active ingredient content and impurities (e.g. breakdown products, reaction products, residues from the manufacturing process ). Pharmaceutical analysis is important in the context of pharmaceutical development , quality control of raw materials, semi-finished goods and finished drugs and medical products , as well as for stability testing of drugs . The spectrum of methods ranges from those with low equipment requirements (e.g. for the pharmacy laboratory) to complex equipment methods . Most methods of pharmaceutical analysis in pharmacopoeia described.
The method validation regulated by guidelines plays a special role, especially in pharmaceutical analysis , since the approval of finished medicinal products requires validated analysis methods.
Pharmaceutical analysis is a subject in pharmacy studies, the "Basics of pharmaceutical analysis" are the subject of the examination in the first section of the pharmaceutical examination .
Pharmaceutical analysis is also an area of specialization in the context of professional training for pharmacists ( “specialist pharmacists for pharmaceutical analysis” ).
literature
- Hermann J. Roth : Pharmaceutical Analysis , 3rd Edition, Georg Thieme Verlag, Stuttgart • New York 1989, ISBN 3-13-548003-8
Individual evidence
- ↑ for example in the European Pharmacopoeia, see Ph. Eur. 7th edition, 4th supplement, general register (PDF document; 385 kB) .
- ^ ICH Q2: Validation of Analytical Procedures - Text and Methodology .
- ↑ VICH : GL1 validation of analytical procedures - Definition and Terminology; GL2 Validation of analytical procedures - Methodology ( Memento from February 26, 2014 in the Internet Archive ).
- ↑ Appendix 1 to Section 2 (2), Licensing Regulations for Pharmacists (AAppO).
- ↑ Appendix 13 to Section 17 (3), Licensing Regulations for Pharmacists (AAppO).
- ^ ABDA - Federal Association of German Pharmacists' Associations: Further training: areas of specialization .