IPOMEANOL

NSC - 349438

SMILES: c1occc1C(CC[CH](O)C)=O

Chemical Name: 1-(3-Furanyl)-4-hydroxy-l-pentanone

CAS Registry Number: 55659-41-1

Molecular Formula: C9H12O3     M.W.: 168.2

How Supplied: Injection, 20 mg, vial: supplied as a clear,
colorless liquid containing 10 mg /mL of ipomeanol in 0.9%
sodium chloride, USP, and sodium hydroxide to adjust pH to 4 to
7, in a 3 mL flint vial.

Injection, 500 mg, vial: supplied as a clear, colorless liquid
containing 10 mg/mL of ipomeanol in 0.9% sodium chloride ,
USP, and sodium hydroxide to adjust pH to 4 to 7, in a 60 mL
flint vial.

Storage: Store the intact vials stored under refrigeration(2-8 °C).

Stability: Shelf-life surveillance of the intact vials is ongoing.
Three lots have maintained stability for 5 years under refrigeration
(2 -8 °C). The intact vials were unstable at elevated temperature (50 °C).

Aqueous solutions of ipomeanol are very stable over a pH range
of 3 to 8.

Dilution of the ipomeanol to a concentration of 0.1 mg/mL in
0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection,
USP, in glass bottles and PVC plastic bags yielded the following
results:

Percentage of Initial Ipomeanol Remaining in Solution

						Days
-------------------------------------------------------------
Diluent 	Temp 	Container 	1 	2 	3
		(°C)

D5W b 		 37 	glass 		100 	100 	100
			PVC 		99 	98 	97

		 25 	glass 		100 	100 	100
			PVC 		99 	99 	98

		 4 	glass 		100 	100 	100
			PVC 		100 	100 	100

NS c 		 37 	glass 		99 	99 	100
			PVC 		99 	97 	95

		 25 	glass 		99 	100 	100
			PVC 		98 	98 	98

		 4 	glass 		100 	100 	100
			PVC 		99 	99 	100

    (a) Initial ipomeanol concentration 0.1 mg/mL
    (b) 5% Dextrose Injection, USP
    (c) 0.9% Sodium Chloride Injection, USP


    CAUTION: Ipomeanol is a potent lung toxin
    (1,2,3). (Refer to toxicology information in the
    clinical brochure.) Great care should be taken by
    those preparing and handling ipomeanol to avoid
    contact with the product or its dilutions, including
    avoiding the formation of aerosols during
    preparation. The use of a suitable biological safety
    cabinet and protective gloves, gowns, masks, eye
    protection, etc., is strongly recommended.


Route of Administration: Intravenous

References:

1. Wilson BJ, Yang DTC, and Boyd MR, Nature 227:521-522, 1970.

2. Boyd MR and Wilson BJ, J Agric Food Chem 20:428-430,1972.

3. Elhawari M, et al: Proc AACR 28:440, 1987.