DOLASTATIN-10
(NSC 376128)
HOW SUPPLIED:
Dolastatin-10 is supplied as a 200 mcg vial. Each sterile vial contains one mL of a solution of 200 mcg/mL (0.2
mg/mL) of Dolastatin-10 in 0.1 molar pH seven phosphate buffer.
STORAGE:
Store the intact vials in the refrigerator (2-8oC).
STABILITY:
Dolastatin-10 solutions of the above composition were stable for at least six months when stored at
40oC. The clinical supplies are currently stored in the refrigerator, and long term stability
studies are ongoing to define storage conditions and shelf-live for future batches.
Due to the lack of a strong UV chromophore in the molecule, reliability of the HPLC measurements for
concentration and impurities is poor below 100 mcg/mL of Dolastatin-10. For this reason, studies were not
performed to determine the stability and compatibility of Dolastatin-10 when further diluted with IV fluids
from the 200 mcg/mL solution.
However, a stability/compatibility study of dolastatin-10 solutions (200mcg/mL) was performed in 1 mL
Monoject® tuberculin syringes equipped with 1" 22 gauge needles. The syringes were filled with either 100
microliters (mcL) or 400 mcL of the drug solution and held at room temperature for four hours. The recovered
solutions indicated no loss in potency or a change in impurity levels.
For administration of volumes less than one mL of Dolastatin-10 solution, we recommend the use of tuberculin
syringes and injection of the drug solution into the Y-site of a running IV line of NS or D5W.
CAUTION: The single-use vial contains no antibacterial preservatives. Therefore, it is advised
that the product be discarded 8 hours after initial entry.
ROUTE OF ADMINISTRATION:
Intravenous