Packaging and storage—
Preserve in well-closed containers.
Identification—
B: Ultraviolet Absorption 
197U
—
Solution:
15 µg per mL.
Medium:
methanol.
Absorptivities at 290 nm, calculated on the dried basis, do not differ by more than 3.0%.
C:
A solution (1 in 50) responds to the tests for
Chloride 191.
Melting range 741:
between 215
and 219
, but the range between beginning and end of melting does not exceed 2
.
Loss on drying 731—
Dry it at 105
to constant weight: it loses not more than 1.0% of its weight.
Heavy metals, Method II 231:
0.001%.
Chromatographic purity—
Dissolve 100 mg in methanol, and dilute with methanol to 5.0 mL to obtain the
Test solution. Dissolve a suitable quantity of
USP Cyclobenzaprine Hydrochloride RS in methanol to obtain a
Standard solution having a known concentration of about 20 mg per mL. Dilute a portion of this solution quantitatively and stepwise with methanol to obtain a
Diluted standard solution having a concentration of about 100 µg per mL. Apply separate 5-µL portions of the three solutions to the starting line of a suitable thin-layer chromatographic plate (see
Chromatography 621) coated with a 0.25-mm layer of chromatographic silica gel mixture and previously washed with methanol. Develop the chromatogram in a suitable chamber with a freshly prepared solvent system consisting of a mixture of acetone, toluene, and ammonium hydroxide (75:25:1) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, air-dry, and view under short-wavelength UV light: the
RF value of the principal spot from the
Test solution corresponds to that of the
Standard solution; and any other spot obtained from the
Test solution does not exceed, in size or intensity, the principal spot obtained from the
Diluted standard solution (0.5%).
Organic volatile impurities, Method I 467:
meets the requirements.
Test solution:
200 mg per mL.
Standard solution—
Proceed as directed except to use 100.0 µg of methylene chloride, 12.0 µg of chloroform, 76.0 µg of 1,4-dioxane, and 16.0 µg of trichloroethylene.
Assay—
Dissolve about 400 mg of Cyclobenzaprine Hydrochloride, accurately weighed, in about 80 mL of glacial acetic acid, add 15 mL of
mercuric acetate TS, and titrate with 0.1 N perchloric acid VS, determining the endpoint potentiometrically, using a platinum ring electrode and a sleeve-type calomel electrode containing 0.1 N lithium perchlorate in glacial acetic acid (see
Titrimetry 541). Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 31.19 mg of C
20H
21N·HCl.
Auxiliary Information—
Staff Liaison :
Ravi Ravichandran, Ph.D., Senior Scientist
Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives
USP29–NF24 Page 606
Pharmacopeial Forum : Volume No. 29(4) Page 1024
Phone Number : 1-301-816-8330
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-propylamine hydrochloride