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New Capabilities: Coulometric KF, Osmolality, More TOC Capacity, Visible Particulates for Injections

By September 20, 2021February 21st, 2022No Comments

Coulometric Karl Fischer allows for trace water determination, and complements the traditional Karl Fischer which is used for higher concentrations of water.
Coulometric Karl Fischer is similar to traditional Karl Fischer where iodine reacts with water in the presence of sulphur dioxide. The difference is that the iodine is generated electrochemically and quantitatively by an electric current. Water content is determined by counting electrons, hence the term “coulometric”.
The system is currently in use with installation and qualification according to GAMP5 protocols. The technique is used in many pharmacopoeial monographs particularly for material of low water content, such as oils.

Osmolality was traditionally used during the development phase of parenteral formulations. This has changed in recent years, reflecting the increased caution of developers of these products, and it is now not unusual to measure osmolality progressively through a stability study.
In response to this requirement by industry and research, Chemika has received delivery of a freezing point osmometer. The apparatus is currently being installed and qualified according to GAMP5 principles.

More TOC Capacity: TOC is used for critical testing of manufacturing water, and any interruption to testing can directly lead to an interruption of manufacturing schedules. We now have a second TOC to provide redundancy and allow for the most robust service standards possible.

USP Visible Particulates for Injections testing has been improved with the delivery of an inspection cabinet manufactured to comply with the requirements of USP.