Page 15 - 2_Pharmaceutical industry

Sum parameter – Total Organic Carbon

TOC – Determination according to USP 661.1
Testing of Plastic Packaging Systems and their
Materials of Construction
SCA-130-207

Plastic packaging systems for pharmaceutical For the TOC determination a purified water
products must be suitable for their intended extraction is prepared. For example 25g
use. The US Pharmacopeia revised the plastic material is placed in a glass flask,
related chapter. It is published in USP 39- 500ml purified water added and boil under
NF34, which will be valid from May 2016. reflux condition for 5h. After cooling, the
solution is pass through a sintered-glass filter.
Besides to the change of the title “Plastic The parameter of the sample weight, purified
Packaging Systems and their materials of water volume and heating temperature and
Construction”, two new chapters are time depends of the used plastic sample.
established. The TOC of the ultra-pure water is subtracted

This application note is related to the first for the measured value of the extraction
chapter 661.1. solution. The resultant TOC value must not
exceed 5mg/l.

■ TOC determination in pharmaceutical
application
The TOC determination is performed
according to the USP<643>. This regulation
describes the TOC determination for pure
water, purified water and water for injection. It
does not prescribe any particular oxidation
technique for TOC determination.
The TOC systems, however, must be able to
differentiate between inorganic and organic
■ 661.1 Plastic Materials of Construction carbon. This can be carried out either via
The purpose of this chapter is to provide test removal of the inorganic carbon (NPOC
methods and standards for plastic materials method), or via a separate determination
(e.g polyethylene, polyolefins, polypropylene) (difference method). The limit of detection for
of construction used in packaging systems for TOC should be at least 0.05 mg /L. The
therapeutic products. The characterization is applicability of the method must be determined
done by identity, biocompatibility (biological via a system suitability test.
reactivity), General physicochemical However, material extracts may have TOC
properties and Additives and extractable values that are higher than those of purified
metals. water because of extracted organic
substances.
The TOC parameter as an indicator for Thus the TOC analyses performed should
extractable material is part of the have a limit of detection of 0,2mg/L and should
physiochemical properties that must be have a demonstrated linear dynamic range
determined. from 0,2 – 20mg/L.