Pharmaceutical Grade Purified Water

Dear fresh water systems regarding pharmaceutical grades of water purified water can be made using any suitable method.

Pharmaceutical grade purified water.

Points of use must be sanitized with alcohol prior to sampling. The microbial counts recommended in usp 1231 for purified water and water for injection are scientifically justified. Fda inspection technical guide number 36 reverse. It is the maintainence of the water production system that is of concern to those in water treatment.

Purified water must not contain any gram negative bacteria. 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. Fda letter to the pharmaceutical industry re. Michels bureau of drugs aug.

However it must pass the usp shelf life standards which are detailed in the folowing tables. Validation and control of deionized water systems daniel l. Thermophilic bacteria can be found in pharmaceutical grade waters. 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. Purified water is used in the pharmaceutical industry. As a purified water distributor hawkins distributes purified water to various companies for a variety of applications and uses.