IODODEOXYURIDINE

The following information applies to the investigational dosage
form of iododeoxyuridine. For information on the commercially
available dosage form, consult the package insert supplied by the
manufacturer.

NSC - 39661

SMILES: OCC1OC(CC1O)N2C=C(I)C(=O)NC2=O

Chemical Name: 5-Iodo-2'-deoxyuridine

Other Names: IDU, IUdR, IdUrd, Idoxuridine (USAN)

CAS Registry Number: 54-42-2

Molecular Formula: C9H11IN2O5    M.W.: 354.1

How Supplied: Sterile, 200 mg, vial: supplied as a white
lyophilized powder with sodium hydroxide to adjust pH in 30 mL
amber vials.

Solution Preparation: 200 mg/vial: When constituted with 10
mL of Sterile Water for Injection, USP, each milliliter contains
iododeoxyuridine 20 mg with sodium hydroxide to adjust to pH 9
to 10.

Storage: Store the intact vials at room temperature.

Stability: Intact vials are stable for five years when stored at room
temperature and are stable for at least one year when stored at
elevated temperatures (50 °C).

At a concentration of 20 mg/mL in distilled water, iododeoxy-
uridine is stable exhibiting less than 2% decomposition in 2 days
at room temperature (22-25 °C). Particulate matter was observed
in the solution after 2 days.

Diluted to a concentration of 0.5 mg/mL in 5 % Dextrose Injection,
USP, or 0.9% Sodium Chloride Injection, USP, iododeoxyuridine
is also stable, exhibiting less than 4% decomposition in 14 days at
room temperature (22-25 °C).

CAUTION: The single-use lyophilized dosage
form contains no antibacterial preservatives.
Therefore, it is advised that the constituted product
be discarded within 8 hours of initial entry.

Route of Administration: Intravenous