Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute

Importancia y uso:

5.1 Pharmaceutical water is the most common component or ingredient used in pharmaceutical and biopharmaceutical manufacturing. Acceptable purity of the water is important to the quality of the final pharmaceutical product. TOC concentration is a key indicator and attribute of the purity of this water and also an important monitor of the overall performance of the water purification system. TOC analysis is the measurement of all the covalently bound carbon present in the water, not including carbon in the form of carbon dioxide (CO₂), bicarbonate ion (HCO₃ ^–), or carbonate ion (CO₃ ^2–), and is reported as the mass of organic carbon per volume.

5.2 Application of this practice provides pertinent information to make informed decisions on the release of water meeting pharmaceutical TOC concentration specifications.

Subcomité:

E55.12

Referida por:

E2898-20A

Volúmen:

14.01

Número ICS:

11.120.10 (Medicaments), 13.060.50 (Examination of water for chemical substances)