Pharmaceutical Grade Purified Water

Purified water must not contain any gram negative bacteria.

Pharmaceutical grade purified water.

Purified water supplied by hawkins inc. 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. 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. Thermophilic bacteria can be found in pharmaceutical grade waters.

Dear fresh water systems regarding pharmaceutical grades of water purified water can be made using any suitable method. 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. Fda letter to the pharmaceutical industry re.

Is a purified water supplier. It contains no added substance and meets all the requirements of the tests for purified. However it must pass the usp shelf life standards which are detailed in the folowing tables. Fda inspection technical guide number 36 reverse.

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