NSC 361456

Chemical Data

How Supplied

Sterile, 500 mg, vial: supplied as a yellow lyophilized powder in 20 mL amber vials. The pH has been adjusted with hydrochloric acid.

Solution Preparation

500 mg/vial: When constituted with 9.8 mL of Sterile Water for Injection, USP, each milliliter contains 50 mg of pyrazine diazohydroxide at a pH of 9.0 to 10.5.

Storage

Store the intact vials in the freezer (-10 to -20 °).

Stability

Shelf-life surveillance of the intact vials is ongoing. The current stability data supports stability for at least 5 years at refrigeration temperature.

The constituted solution is chemically and physically stable for 24 hours at room temperature.

When the constituted solution is diluted in 0.9% Sodium Chloride, USP, or 5 % Dextrose in Water, USP, to a concentration of 1 mg/mL in glass bottles the solution is stable for 24 hours at refrigerated temperature (4 °) and 4 hours at room temperature. The stability in PVC plastic bags was reduced to 8 hours at refrigerated temperatures (4 °) and 4 hours at room temperature.

CAUTION: The single-use freeze dried dosage form contains no antibacterial preservatives. Therefore, the constituted solution should be discarded within 8 hours of initial entry.

Route of Administration

Intravenous