Physicochemical Test Methods

Particulate contamination – sub-visible particles
Determination of chlorides

Particulate contamination – sub-visible particles

Article	Article No.
Particle count - light obscuration	7100025
Particle count - microscopic	7100026

Determination of sub-visible particles (measured particle sizes: 10μm and 25μm), which have been unintentionally introduced into liquids (e.g. solutions and containers) as a result of contamination with foreign, undissolved particles (exceptions: gas bubbles).

Limit values according to Ph. Eur.

Normative references

European Pharmacopoeia (Ph. Eur.): 2.9.19 Particulate contamination – sub-visible particles

United States Pharmacopeia (USP):

<788> Particulate Matter in Injections
<789> Particulate Matter in Ophthalmic Solutions

Japanese Pharmacopoeia (JP):

24 Insoluble Particulate Matter Test for Injections
25 Insoluble Particulate Matter Test for Ophthalmic Solutions

Determination of chlorides

The following determinations are carried out by ACILA:

1. Limit test:

Article	Article No.
Determination of chlorides (limit test)	7210012

Determination of the content of chloride ions in water by photometric measurement of the turbidity occurring during precipitation with silver nitrate in the presence of diluted nitric acid. Due to the high sensitivity, this test is preferably carried out as a limit test for purity testing.

Normative references:

European Pharmacopoeia (Ph. Eur.)

2.4.4 Chlorides
0169: Water for injection (aqua ad iniectabilia)

United States Pharmacopeia (USP)

<1231> Water for pharmaceutical purposes

2. Content determination:

Article	Article No.
Determination of chloride (content determination) in water or aqueous solutions	7210010

The chloride content is determined by means of potentiometric titration. A metal combination electrode for halogenide titrations AgCl 65 Glass shaft, platinum junction is used as the electrode, which is immersed in the analytical solution. The content is determined by adding silver nitrate solution in nitric acid.

At the equivalence point, the potential increases significantly and can therefore be evaluated using the usual methods.