Pharmaceutical Grade Purified Water

Validation and control of deionized water systems daniel l.

Pharmaceutical grade purified water.

The microbial counts recommended in usp 1231 for purified water and water for injection are scientifically justified. Thermophilic bacteria can be found in pharmaceutical grade waters. Purified water must not contain any gram negative bacteria. As a purified water distributor hawkins distributes purified water to various companies for a variety of applications and uses.

Michels bureau of drugs aug. Fda inspection technical guide number 36 reverse. Pharmaceutical group meets the standards of united states pharmacopeia usp. Purified water is used in the pharmaceutical industry.

Points of use must be sanitized with alcohol prior to sampling. Dear fresh water systems regarding pharmaceutical grades of water purified water can be made using any suitable method. 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 supplied by hawkins inc.

Fda letter to the pharmaceutical industry re. Is a purified water supplier. 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.