Pharmaceutical Grade Purified Water

The microbial counts recommended in usp 1231 for purified water and water for injection are scientifically justified.

Pharmaceutical grade purified water.

Purified water is used in the pharmaceutical industry. Thermophilic bacteria can be found in pharmaceutical grade waters. Fda inspection technical guide number 36 reverse. Water for injection is a solvent used in the production of parenteral and other preparations where product endotoxin content must be controlled and in other pharmaceutical applications water for injection wfi is sterile non pyrogenic distilled water for the preparation of products for parenteral use.

Purified water must not contain any gram negative bacteria. Fda letter to the pharmaceutical industry re. However it must pass the usp shelf life standards which are detailed in the folowing tables. Michels bureau of drugs aug.

As a purified water distributor hawkins distributes purified water to various companies for a variety of applications and uses. Validation and control of deionized water systems daniel l. Pharmaceutical group meets the standards of united states pharmacopeia usp. Water of this grade is widely used as a raw material ingredient and solvent in the processing formulation and manufacture of pharmaceutical products active pharmaceutical ingredients apis and intermediates compendial articles and analytical reagents.

It is the maintainence of the water production system that is of concern to those in water treatment. Purified water supplied by hawkins inc. Points of use must be sanitized with alcohol prior to sampling.