Water by Karl Fischer titration (volumetric)

Quantitative determination of water content of bulk material, of lyophilisates and of other test material delivered in vials (analysis of the unopened vial). Method can also be performed as micro technique with significantly reduced amount of test substance.

Therapeutic Modalities:

Biologics, Small Molecules

Development Phases:

Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial

Quality Standard:

GMP and non-GMP (ISO 9001:2015)

Pharmacopoeia:

Ph. Eur. general method 2.5.12, USP-NF general method <921>