Table 6.

Specifications for Printex-U- suspension in saline

Test item	Method	Acceptance criteria
Description	Visual observation	Grey suspension
Primary particle size	Transmission Electron Microscopy (TEM)	< 100 nm
Ratio agglomerates <100 nm vs >100 nm	Nanoparticle Tracking Analysis (NTA)	> 50 % agglomerates/particles <100 nm
Purity	TEM/EDX	99 % carbon particles, description of the other 1 %
Arrangement	TEM	Onion-like
Contamination	TEM	No heavy metals
Microbiologic contamination	LAL-test (according to Annex 10)	< 0.1 Eu/ml