Water, purified

• BPPurified Water
• JPPurified Water
• Ph. Eur.Water, Purified
• USP–NFPurified Water

Aqua purificata; demineralised water; deionised water; distilled water; PW; purified water in bulk

Water · [7732-18-5]

UNII 059QF0KO0R · PubChem CID 962

H2O · 18.02

Solvent, humectant

Typical concentrations: — · Dosage forms: Liquid, Semi-solid

The most widely used pharmaceutical solvent and vehicle, used in the manufacture of non-parenteral products such as oral liquids and topical preparations, in wet granulation and coating, for cleaning equipment and as feed water for water for injections. It is not suitable for parenteral products unless further treated.

A clear, colourless, odourless and tasteless liquid. It is water purified to pharmacopoeial chemical and microbiological standards and contains no added substances.

Conductivity

not more than 1.3 µS/cm at 25 °C (USP stage 1); Ph. Eur. bulk limit 5.1 µS/cm at 25 °C

Total organic carbon

not more than 0.5 mg/L (500 ppb)

Microbial count

action level 100 CFU/mL

Density

0.997 g/cm³ at 25 °C

Boiling point

100 °C

Chemically stable, but readily supports microbial growth and biofilm formation in storage and distribution systems. Systems should be kept circulating, sanitised regularly (by heat, ozone or chemicals) and monitored; water should not be stored for long periods.

Reacts with drugs and excipients susceptible to hydrolysis and with water-reactive materials. Dissolved carbon dioxide lowers the pH slightly.

Prepared from drinking water by distillation, ion exchange, reverse osmosis, electrodeionisation or a combination of these, usually after pretreatment such as softening, carbon filtration and microfiltration.

Non-toxic. The main risk to product quality and patients is microbial contamination, including with Pseudomonas and other water-borne organisms, in poorly controlled systems.

Water systems must be designed, validated and routinely monitored for conductivity, TOC and microbial quality. Hot-sanitised systems present a burn hazard.

Included in the FDA Inactive Ingredient Database (oral, topical, ophthalmic, inhalation and other non-parenteral preparations) and in non-parenteral medicines licensed worldwide.

Water for injection; sterile purified water; highly purified water (former Ph. Eur. grade).

Products made with purified water and packaged in multidose containers usually need an antimicrobial preservative. Where a monograph or process requires microbial control, sterile purified water or water for injections may be specified instead.