Page 13 - 2_Pharmaceutical industry

Sum parameter – Total Organic Carbon

TOC – Determination according to USP 643
(USP 36-NF 31)

SCA-130-206

In 1996, the US Pharmacopeia has The chapter ‘Sterile Water’ is new. It includes
introduced the TOC parameter for the sterile purified water, sterile water for
determination of impurities in purified water injections, sterile water for irrigation and
and water for injections. For other waters sterile water for inhalation. Sterile water can
used in the pharmaceutical industry, the wet- be stored in various packaging
chemical potassium permanganate test configurations. In comparison to bulk water,
continued to be used. Meanwhile however, however, other conditions for TOC
TOC determination has proven to be so determination apply:
effective that it now replaces the wet-
chemical test. Limit of detection: < 0.05 mg/L C
Blank water, r w: max. 0.1 mg/L C
Standard (sucrose), r s: 8 mg/L C
SST (benzoquinone), r ss: 8 mg/L C
Permitted response: 85 – 115%
Limit response (waters) r u: < (r s-r w)

■ Impact of the new determination
The present requirements of the UPS <643>
(bulk water) are consistent with the
requirements of the European Pharmacopeia
(limit of detection, concentration of the
standard solution (sucrose) and system
suitability solution (benzoquinone and
response). Validation of the TOC system for
In the current version of the UPS <643> (USP
36-NF 31) a distinction is made between ‘bulk both determinations is therefore sufficient.
water’ and ‘sterile water’. The chapter ‘Bulk
Water’ includes purified waters that are to be In accordance with the new USP <643>, the
used right away as purified water, water for implementation of a system suitability test
injection, water for hemodialysis and as using higher concentrations is required.
condensate of pure steam. The following
known conditions apply to TOC For users of Shimadzu’s TOC systems, this
determinations: just means the creation of an additional
calibration curve (sucrose, 8 mg/L, see figure
Limit of detection: < 0.05 mg/L C 1) and control sample (benzoquinone, 8
Blank water, r w: max. 0.1 mg/L C mg/L, see figure 2) as well as extension of
Standard (sucrose), r s: 0.5 mg/L C the current validation process with these
SST (benzoquinone), r ss: 0.5 mg/L C data.
Permitted response: 85 – 115%
Limit response (waters) r u: < (r s-r w)