FORANE Liquid for inhalation Ref.[10816] Active ingredients: Isoflurane

Source: FDA, National Drug Code (US)  Revision Year: 2017 

Product description

FORANE (isoflurane, USP), a nonflammable liquid administered by vaporizing, is a general inhalation anesthetic drug. It is 1-chloro-2,2,2-trifluoroethyl difluoromethyl ether, and its structural formula is:

Some physical constants are:

Molecular weight: 184.5
Boiling point at 760 mm Hg: 48.5°C
Refractive index n20D: 1.2990-1.3005
Specific gravity 25°/25°C: 1.496

Vapor pressure in mm Hg**:

20°C – 238
25°C – 295
30°C – 367
35°C – 450

** Equation for vapor pressure calculation:

log10Pvap = A + B/T where:

A = 8.056
B = -1664.58
T = °C + 273.16 (Kelvin)

Partition coefficients at 37°C:

Water/gas 0.61
Blood/gas 1.43
Oil/gas 90.8

Partition coefficients at 25°C – rubber and plastic:

Conductive rubber/gas 62.0
Butyl rubber/gas 75.0
Polyvinyl chloride/gas 110.0
Polyethylene/gas~2.0
Polyurethane/gas~1.4
Polyolefin/gas ~1.1
Butyl acetate/gas ~2.5
Purity by gas chromatography >99.9%
Lower limit of flammability in
oxygen or nitrous oxide at 9
joules/sec. and 23°C
None
Lower limit of flammability in oxygen
or nitrous oxide at 900 joules/sec. and 23°C
Greater than useful concentration in anesthesia.

Isoflurane is a clear, colorless, stable liquid containing no additives or chemical stabilizers. Isoflurane has a mildly pungent, musty, ethereal odor. Samples stored in indirect sunlight in clear, colorless glass for five years, as well as samples directly exposed for 30 hours to a 2 amp, 115 volt, 60 cycle long wave U.V. light were unchanged in composition as determined by gas chromatography. Isoflurane in one normal sodium methoxide-methanol solution, a strong base, for over six months consumed essentially no alkali, indicative of strong base stability. Isoflurane does not decompose in the presence of soda lime (at normal operating temperatures), and does not attack aluminum, tin, brass, iron or copper.

How Supplied

FORANE (isoflurane, USP) is packaged in 100 mL and 250 mL amber-colored bottles.

100 mL NDC 10019-360-40
250 mL NDC 10019-360-60

FORANE (isoflurane, USP) is also supplied in the following aluminum bottles.

250 mL NDC 10019-360-64

Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015 USA

Drugs

Drug Countries
FORANE Canada, Estonia, Lithuania, Nigeria, New Zealand, Poland, Turkey, United States, South Africa

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