MISONIDAZOLE

NSC - 261037

SMILES: COCC(O)Cn1ccnc1[N+](=O)[O-]

Chemical Name: a-(Methoxymethyl)-2-nitro-1H-imidazole-1-ethanol

Other Names: Ro-7-0582, 1-(2-nitroimidazolyl)-3-methoxy-2-propanol

CAS Registry Number: 13551-87-6

Molecular Formula: C7H11N3O4   M.W.: 201.2

How Supplied: For injection, 500 mg, vial: supplied as a light
yellow lyophilized powder with 300 mg of mannitol, USP, in 30
mL amber vials.

Solution Preparation: 500 mg/vial: When constituted with 19.6
mL of 0.9% Sodium Chloride Injection, USP, or Sterile Water for
Injection, USP, each milliliter contains 25 mg of misonidazole and
15 mg of mannitol, USP, pH 5.0 to 7.0.

CAUTION: Some vials contain undissolved
misonidazole after constitution. Complete
reconstitution can be achieved by warming the
mixture at 40 °C or constituting with 25 mL of
diluent initially for a misonidazole concentration of
20 mg/mL.

Storage: Store the vials at room temperature (22-25 °C).

Stability: Shelf-life surveillance studies are continuing. The intact
vials are stable for at least 3 years at room temperature (22-25
°C). The intact vials are stable for at least one year when stored
at elevated temperature (50 °C).

Constitution of the vials as directed results in a solution which is
chemically stable for at least 14 days at room temperature,
exhibiting less than 2% decomposition.

Further dilution of the freshly constituted solution to a
concentration of 1 gm/L in 5% Dextrose Injection, USP, resulted
in less than 1% decomposition in 14 days at room temperature.
The stability of solutions of misonidazole is unaffected by exposure
to light.

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