Page 18 - Application Handbook - TOC

2. Pharmaceutical industry

Pharmaceutics is an ancient science that European Pharmacopoeia = EP). The drug batch, the TOC parameter is used dance with EP 2.2.44’). In addition to
has supported people with remedies to sum parameter serves as a measure of for the evaluation of the cleaning pro- pharmaceutical applications, there are
help alleviate pain and heal illnesses. contamination by organic compounds. cess. The TOC not only mirrors the pres- also application notes and information
After medication, certain substances are Not only the method itself is described, ence of drugs, but also reveals other on ‘Environmental analysis’, ‘Chemical
expected to unfold their beneficial ef- but also a test to verify the suitability contaminants such as those from clean- industry’, ‘TOC special applications’,
fects – while side effects from interfer- of a TOC analyzer for the analysis. ing agents. ‘TOC in daily practice’ and ‘TOC process
ing substances and contaminations are analysis.’
undesirable. This is why it is important In addition to ultrapure water required With its TOC analyzers, Shimadzu offers
to use the purest possible substances for the manufacture of drugs, water for systems that are suitable for many dif-
and purified equipment and materials in injections – water that is directly inject- ferent TOC analysis issues in the phar-
the production of drugs. ed into the bloodstream of the human maceutical industry. In addition to the
or animal body – is also tested for its lowest detection sensitivity, the robust
To meet this standard, legislators have TOC content. The Pharmacopoeia actual- analyzers offer the highest precision and
published Pharmacopoeias. These in- ly specifies a maximum TOC limit value accuracy. Just like the analyzers them-
clude methods and rules for the manu- for such specific waters. selves, the operation and evaluation
facture, storage, quality and testing of software complies with all requirements
drugs. For drug manufacturers, comply- Many drugs are manufactured in batch of the FDA and the Pharmacopoeia.
ing with the rules and methods of the mode operation. Prior to the production
Pharmacopoeia is mandatory. of the next batch, materials and work- Further information can be found in the
ing equipment must be extensively individual application notes (for in-
TOC determination is also described in cleaned. In order to verify that the stance ‘TOC determination in ultrapure
the Pharmacopoeia (for instance the equipment is free from the ‘previous’ water, cleaning validation or in accor-