Water For Injection Usp Conductivity

1927 1929 and 1231 water for pharmaceutical purposes p.

Water for injection usp conductivity.

Not more than 500 ppb. Action levels in usp 1231 100cfu ml for purified water and 10cfu 100ml for water for injection are generally considered to represent a level above which the water is unfit for use. Ankur choudhary print question. Conductivity at 25 c less than 1 3 ms cm.

Some gases notably co 2 readily dissolve in water and interact to form ions which predictably affect conductivity. Usp 645 this standard applies to electrical conductivity one of four critical water quality attributes defined by the united states pharmacopeial convention usp for purified water pw and water for injection wfi. Usp24 contains complete versions of all pharmaceutical water monographs p. That is why an oos investigation must be undertaken if those action levels are exceeded.

The usp united states pharmacopeia defines this as highly purified waters containing less than 10 cfu 100 ml of aerobic bacteria. Usp bacteriostatic water for injection usp sterile water for irrigation the usp designation means that the water is the subject of an official monograph in the current us pharmacopeia with various. 1752 1754 and the general chapters 643 toc 645 water conductivity p. You may purchase usp24 by calling customer service at 800 877 6733.

Water for injection packaged in bulk for commercial use elsewhere meets the requirement of the test for bacterial endotoxins as indicated below and the requirements of all the tests under sterile purified water. Clear colorless and odorless liquid. A balancing quantity of cations such as sodium ion is. For water packaged in bulk but manufactured elsewhere or for sterile purified water sterile water for injection sterile.

The tests for total organic carbon and water conductivity apply to water for injection produced on site for use in manufacturing. Water for injection by definition is water that is intended for use in the manufacture of parenteral i e. The conductivity of the ubiquitous chloride ion at the theoretical endpoint concentration of 0 47 ppm when it was a required attribute test in usp xxii and earlier revisions and the ammonium ion at the limit of 0 3 ppm represents a major portion of the allowed water impurity level. These waters should also have fewer than 500 ppb of total organic.

Water conductivity is also affected by the presence of. The usp is also available at pharmacy colleges. Know the specification of water for injection wfi as per united states. Injectable drugs whose solvent is water.

Know the specification of water for injection wfi as per united states pharmacopoeia.