Overview of the Requirements on WFI in the EU, USA and Japan

Again and again, the question arises about the limits laid down in the different GMP regulations and Pharmacopoeias and what procedures are applicable to the manufacture of water for injection (WFI). The table below gives you an overview of the current requirements on the production as well as on certain testing elements. It is remarkable to notice that only EU authorities are against the inclusion of membrane procedures for the production of WFI.  

 

USP

EP

JP

Production of WFI

Distillation or purification process proven to be equivalent or superior to distillation

Distillation only

Distillation or RO/UF

Conductivity

[µS/cm at 25 °C or equivalent at other temperatures]

1.3

1.3

1.3

TOC [ppb]

≤ 500

≤500

≤ 500

Endotoxin

0.25 EU/mL

0.25 EU/mL

0.25 EU/mL

Bacteria [cfu/100 mL]

10

10

10

Nitrates [ppm]

N/A

0.2

N/A

Ammonium [mg/L]

N/A

N/A

N/A

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GMP Conferences by Topics

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