Phenmetrazine Hydrochloride
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C11H15NO·HCl 213.70

Morpholine, 3-methyl-2-phenyl-, hydrochloride.
3-Methyl-2-phenylmorpholine hydrochloride [1707-14-8].
» Phenmetrazine Hydrochloride, dried at 105 for 2 hours, contains not less than 98.0 percent and not more than 102.0 percent of C11H15NO·HCl.
Packaging and storage— Preserve in tight containers.
A: Infrared Absorption 197S
Solution: 1 in 20.
Medium: chloroform.
B: Ultraviolet Absorption 197U
Solution: 500 µg per mL.
Medium: 0.5 N hydrochloric acid.
Melting range, Class Ia 741: between 172 and 182, but the range between beginning and end of melting does not exceed 3.
pH 791: between 4.5 and 5.5, in a solution (1 in 40).
Loss on drying 731 Dry it at 105 for 2 hours: it loses not more than 0.5% of its weight.
Residue on ignition 281: not more than 0.1%.
Sulfate 221 A 2.0-g portion shows no more sulfate than corresponds to 0.20 mL of 0.020 N sulfuric acid (0.01%).
Chloride content— Transfer about 350 mg, previously dried and accurately weighed, to a 250-mL beaker. Add about 125 mL of water and 10 drops of sulfuric acid, and stir for 15 minutes with a magnetic stirrer. Titrate the solution potentiometrically with 0.1 N silver nitrate VS, using a silver-mercurous sulfate electrode system with a saturated salt bridge of potassium sulfate. Each mL of 0.1 N silver nitrate is equivalent to 3.545 mg of Cl: the content is between 16.3% and 17.0%.
Ordinary impurities 466
Test solution: methanol.
Standard solution: methanol.
Eluant: a mixture of chloroform, absolute alcohol, and ammonium hydroxide (80:20:1).
Visualization: 1.
Assay— Transfer to a 200-mL volumetric flask about 100 mg of Phenmetrazine Hydrochloride, previously dried and accurately weighed. Dissolve in 0.5 N hydrochloric acid, dilute with 0.5 N hydrochloric acid to volume, and mix to obtain the Assay preparation. Concomitantly determine the absorbances of the Assay preparation and of a Standard solution of USP Phenmetrazine Hydrochloride RS, in the same medium having a known concentration of about 500 µg per mL, in 1-cm cells, at the wavelength of maximum absorbance at about 256 nm, with a suitable spectrophotometer, using 0.5 N hydrochloric acid as the blank. Calculate the quantity, in mg, of C11H15NO·HCl in the Phenmetrazine Hydrochloride taken by the formula:
0.2C(AU / AS)
in which C is the concentration, in µg per mL, of USP Phenmetrazine Hydrochloride RS in the Standard solution, and AU and AS are the absorbances from the Assay preparation and the Standard solution, respectively.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Clydewyn M. Anthony, Ph.D.
(MDCCA05) Monograph Development-Cough Cold and Analgesics
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 3269
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.