Sterile water for injection (revision 3)
Old revision·14:27, 26 Aug 2024·CDMO_Caradoc
| Sterile water for injection | |
|---|---|
| Composition | Water only; no preservative, no buffer, no tonicity agent |
| Container | Single-entry |
| Contrast with | Bacteriostatic water, preserved |
| Topic infobox · conventions | |
Sterile water for injection is water that has been sterilised and meets compendial requirements for particulates, endotoxin and conductivity, supplied without preservative, buffer or tonicity agent. It is intended for single use in preparing an injection.[1]
Because it contains no preservative, a container that has been entered offers no barrier to growth of organisms introduced at entry, and it is therefore packaged and used as single-entry. This is the operative difference from bacteriostatic water.[2]
Compendial requirements
[edit]The relevant monograph specifies sterility, freedom from pyrogens, limits on conductivity and total organic carbon, and particulate matter limits. It is prepared by distillation or by a purification process of equivalent capability, and it is not simply purified water in a sealed container.[1]
Sterility of the water is not the same as sterility of the preparation made from it. A non-sterile powder reconstituted in sterile water yields a non-sterile solution, and the water's compendial status does not transfer. See Sterility testing.