PENTOSTATIN

NSC - 218321

SMILES: OCC1OC(CC1O)n2cnc3[C@H](O)CNC=Nc23

Chemical Name: 3-(2-Deoxy-(3-D-erythro-pentofuranosyl)-3,6,7,8-tetrahydroimidazo[4,5-d][1,3]diazepin-8-o1,(R)-

Other Names: 2'-Deoxycoformycin, Co-Vidarabine, Nipent, Pentostatin (USAN)

CAS Registry Number: 53910-25-1

Molecular Formula: C11H16N4O4    M.W.: 268.3

How Supplied: For injection, 10 mg, vial: supplied as a
lyophilized powder with 50 mg mannitol, USP, and sodium
hydroxide to adjust the pH in 5 mL flint vials.

Solution Preparation: 10 mg/vial: When constituted with 5 mL
of 0.9% Sodium Chloride Injection, USP, each milliliter contains
2 mg of pentostatin and 10 mg of mannitol, USP, at pH 6.7 to
8.7.

Storage: Refrigerate the intact vials (2-8 °C).

Stability: Shelf-life surveillance of the intact vials is ongoing.
Intact vials are stable for 5 years under refrigeration but have gone
below 90% of labeled amount by 3 years storage at room
temperature (22-25 °C). Intact vials are unstable when stored at
elevated temperature (50 °C) for one year. The intact vials bear
a "do not use after" date.

Constitution with 0.9% Sodium Chloride Injection, USP, results
in a solution which is chemically stable at room temperature
(22-25 °C) for at least 72 hours, exhibiting about 2 to 4%
decomposition.

When diluted to a concentration of 10 mg per 500 mL in 0.9%
Sodium Chloride Injection, USP, or Lactated Ringer's Injection,
USP, pentostatin is chemically stable for at least 48 hours at room
temperature (22-25 °C), exhibiting approximately 0 to 4%
decomposition.

At a concentration of 10 mg per 500 mL in 5% Dextrose Injection,
USP, approximately 2% decomposition occurs in 24 hours at room
temperature. As much as 8 to 10% loss has been reported to
occur in 48 hours.

No potency loss was detected in the constituted solution or in
admixtures in 5 % Dextrose Injection, USP, or 0.9% Sodium
Chloride Injection, USP, when refrigerated at 5 °C over 96 hours.

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

Route of Administration: Intravenous