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Materi Cleaning Validation - Hisfarin
Materi Cleaning Validation - Hisfarin
Applications
USP & Cleaning Validation
By Debora Polinengtyas
PT. Ditek Jaya
Applications of TOC Analyzers in
Pharma Industries
Approach II
This approach first purges the IC from the
sample before any Carbon measurement is
performed. However, this IC purging step also
purges some of the organic molecules.
Remaining organic matter in the sample is also
oxidized to CO2 and quantified as Non Purgeable
Organic carbon (NPOC).
TOC = POC + NPOC
In Pharmaceutical water, amount of POC is negligible
and can be discounted. Therefore for the purpose of
this methodology, NPOC is equivalent to TOC.
Apparatus Required
Standards Required
i) USP 1,4 Benzoquinone RS.
ii) USP Sucrose RS.
iii) Reagent Water: Water having TOC level of not
more than 0.10 mg (100 ppb or 0.10 ppm) of
carbon/liter as per USP XXIII and not more
than 0.10 mg (100 ppb or 0.10 ppm) of
Carbon/ liter as per EP.
Glassware Preparation: Use glassware & sample
containers that have been cleaned of organic
residues. Use reagent water for final rinse.
Sample Collection and Handling
2”x2” (US)
4”x4” (Jpn)