What is USP water for injection?

What is USP water for injection?

Sterile Water for Injection, USP, is sterile, nonpyrogenic, distilled water in a single dose container for intravenous administration after addition of a suitable solute. It may also be used as a dispensing container for diluent use. No antimicrobial or other substance has been added.

What is the limit of WFI?

For WFI, the USP guidelines require a conductivity limit of 0.6–4.7 µS/cm, a TOC limit of 500 ppb (µg/L), an endotoxin limit of 0.25 endotoxin units/mL and a bacteria-count limit of 10 cfu/100 mL.

What does USP stand for in sterile water?

The USP designation means that the water is the subject of an official monograph in the current US PHARMACOPEIA with various specifications for each type.

Is UltraPure water sterile?

UltraPure Sterile Water consists of highly polished pharmaceutical grade deionized water processed using sterile conditions This product was aseptically filtered through a Millipore 0.22 micron filter into clean, pre-sterilized containers.

Is sterile water for injection potable?

It is intended for use as an irrigation fluid and not for intravenous administration or administration by other, parenteral routes (e.g., subcutaneous or intramuscular) [see WARNINGS AND PRECAUTIONS]. Sterile Water for Irrigation is not potable water and is not intended for oral administration.

What is the difference between sterile water for injection and water for injection?

Water for injection is water of extra high quality without significant contamination. A sterile version is used for making solutions that will be given by injection. Water for injection is generally made by distillation or reverse osmosis.

What is the limit of TOC in purified water?

6. What is the total organic carbon (TOC) limit for Purified Water and Water for Injection? There is a “target limit response” of 500 µg of Carbon/L. The true limit is the response of the TOC measurement system to a 500 µg Carbon/L (prepared from sucrose) solution, Rs, corrected for the response to reagent water, Rw.

What are USP guidelines?

USP is a scientific nonprofit organization that sets public standards for identity, strength, quality and purity of medicines. USP standards are recognized in various provisions of the federal Food, Drug and Cosmetic Act (FDCA) and in laws, regulations and policies promulgated by states.

What is the difference between BP and USP?

The USP is an independent scientific organisation that develops quality standards for medicines, dietary supplements and food ingredients. The BP is a book of published and publicly available standards for pharmaceutical ingredients and finished medicinal products.