Question

state the requirement for water injection IP​

Answer 1

Specification for Water for Injection (WFI) as per USP

Sr.No. Test Acceptance criteria

1 Description Clear, colorless and odorless liquid.

2 Total Organic carbon Not more than 500 ppb

3 Conductivity (at 25°C) Less than 1.3 mS/cm

4 Bacterial Endotoxins Less than 0.25EU/ml

Answer 2

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Sterile Water for Injection, USP, is sterile, nonpyrogenic, distilled water in a single dose container for intravenous administration after addition of a suitable solute. It may also be used as a dispensing container for diluent use. No antimicrobial or other substance has been added. The pH is 5.5 (5.0 to 7.0).