Butanamide, 2,4-dihydroxy-
N-(3-hydroxypropyl)-3,3-dimethyl-, (
R)-.
D-(+)-2,4-Dihydroxy-
N-(3-hydroxypropyl)-3,3-dimethylbutyramide
[
81-13-0].
Packaging and storage
Preserve in tight containers.
Identification
B:
To 1 mL of a 1 in 10 solution add 5 mL of 1 N sodium hydroxide and 1 drop of
cupric sulfate TS, and shake vigorously: a deep blue color develops.
C:
To 1 mL of a solution (1 in 100) add 1 mL of 1 N hydrochloric acid, and heat on a steam bath for about 30 minutes. Cool, add 100 mg of hydroxylamine hydrochloride, mix, and add 5 mL of 1 N sodium hydroxide. Allow to stand for 5 minutes, then adjust with 1 N hydrochloric acid to a pH of between 2.5 and 3.0, and add 1 drop of
ferric chloride TS: a purplish red color develops.
Specific rotation 781S:
between +29.0
and +31.5
.
Test solution:
50 mg per mL, in water.
Limit of aminopropanol
Transfer about 5 g, accurately weighed, to a 50-mL flask, and dissolve in 10 mL of water. Add bromothymol blue TS, and titrate with 0.1 N sulfuric acid VS to a yellow endpoint. Each mL of 0.1 N sulfuric acid is equivalent to 7.5 mg of aminopropanol. Not more than 1.0% is found.
Organic volatile impurities, Method IV 467:
meets the requirements.
Assay
Potassium biphthalate solution
Dissolve 20.42 g of potassium biphthalate in glacial acetic acid contained in a 1000-mL volumetric flask. If necessary, warm the mixture on a steam bath to achieve complete solution, observing precautions against absorption of moisture. Cool to room temperature, dilute with glacial acetic acid to volume, and mix.
Procedure
Transfer about 400 mg of Dexpanthenol, accurately weighed, to a 300-mL flask fitted to a reflux condenser by means of a standard-taper glass joint, add 50.0 mL of 0.1 N perchloric acid VS, and reflux for 5 hours. Cool, observing precautions to prevent atmospheric moisture from entering the condenser, and rinse the condenser with glacial acetic acid, collecting the rinsings in the flask. Add 5 drops of
crystal violet TS, and titrate with
Potassium biphthalate solution to a blue-green endpoint. Perform a blank determination, and note the differences in volumes required. Each mL of the difference in volumes of 0.1 N perchloric acid consumed is equivalent to 20.53 mg of C
9H
19NO
4.