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OF PHARMA
WATERS
Sheesh Gulati
Monitoring Total Organic
Carbon in Pharmaceutical
High-Purity Water Systems
How to Meet USP <643> and EP 2.2.44
TOC and USP <645> and EP 2.2.38
Conductivity Requirements
TOC -- HISTORY
TOC analysis techniques were
developed back in the 1960s as a
means of better understanding the
contents of potable water and also
f a c t o r y w a s t e w a t e r .
As these waters typically contained high
levels of TOC (up to 1,000PPM), the
analysis techniques were not suitable
f o r U l t r a P u r e Wa t e r.
With advances in technology , newer,
more sophisticated methods of
measuring TOC were developed .
EVOLUTION OF TOC LIMITS
PHARMACEUTICAL GRADE WATER
USP Standard Water for Injection