How does the QbD1200 ensure that the System Suitability Test passes?

Человек в перчатках открывает коробку

Analyzers that have poor TOC analysis reproducibility can struggle to pass the System Suitability Test defined in the USP and EP. Both the USP and the EP require the TOC analyzer to report the analysis of two separate 500ppb TOC solutions within +/-15% of each other, e.g. if the TOC analyzer reports the 500ppb TOC sucrose solution results as 500ppb, then it must report the 500ppb TOC benzoquinone analysis results to within +/-15% of the sucrose results, i.e. between 425ppb and 575ppb. Analyzers that have poor reproducibility of measurement will struggle to get the results from the two 500ppb TOC standards within 15% and so will fail the System Suitability Test. This is a very common problem with general purpose, wide-ranging TOC analyzers not designed specifically for pharmaceutical use (some TOC analyzers can analyze up to 4,000,000ppb TOC (the QbD1200 only works up to 100,000ppb) and are just not designed to give consistent accuracy and reproducibility in the low ppb range).

Accurate reproducibility of the QbD1200 ensures consistent System Suitability Test pass

Accurate reproducibility of the QbD1200 ensures consistent System Suitability Test pass