Phenmetrazine Hydrochloride
;)
Morpholine,3-methyl-2-phenyl-,hydrochloride.
3-Methyl-2-phenylmorpholine hydrochloride [1707-14-8].
»Phenmetrazine Hydrochloride,dried at 105
for 2hours,contains not less than 98.0percent and not more than 102.0percent of C11H15NO·HCl.
for 2hours,contains not less than 98.0percent and not more than 102.0percent of C11H15NO·HCl.
Packaging and storage—
Preserve in tight containers.
Identification—
A:
Infrared Absorption á197Sñ—
Solution:
1in 20.
Medium:
chloroform.
Melting range,Class Ia á741ñ:
between 172and 182,but the range between beginning and end of melting does not exceed 3.
and 182,but the range between beginning and end of melting does not exceed 3.
pHá791ñ:
between 4.5and 5.5,in a solution (1in 40).
Loss on drying á731ñ—
Dry it at 105for 2hours:it loses not more than 0.5%of its weight.
for 2hours:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Sulfate á221ñ—
A2.0-g portion shows no more sulfate than corresponds to 0.20mLof 0.020Nsulfuric acid (0.01%).
Chloride content—
Transfer about 350mg,previously dried and accurately weighed,to a 250-mLbeaker.Add about 125mLof water and 10drops of sulfuric acid,and stir for 15minutes with a magnetic stirrer.Titrate the solution potentiometrically with 0.1Nsilver nitrate VS,using a silver-mercurous sulfate electrode system with a saturated salt bridge of potassium sulfate.Each mLof 0.1Nsilver nitrate is equivalent to 3.545mg of Cl:the content is between 16.3%and 17.0%.
Heavy metals,Method IIá231ñ:
0.001%.
Ordinary impurities á466ñ—
Test solution:
methanol.
Standard solution:
methanol.
Eluant:
a mixture of chloroform,absolute alcohol,and ammonium hydroxide (80:20:1).
Visualization:
1.
Organic volatile impurities,Method Iá467ñ:
meets the requirements.
Assay—
Transfer to a 200-mLvolumetric flask about 100mg of Phenmetrazine Hydrochloride,previously dried and accurately weighed.Dissolve in 0.5Nhydrochloric acid,dilute with 0.5Nhydrochloric acid to volume,and mix to obtain the Assay preparation.Concomitantly determine the absorbances of the Assay preparationand of a Standard solution of USP Phenmetrazine Hydrochloride RS,in the same medium having a known concentration of about 500µg per mL,in 1-cm cells,at the wavelength of maximum absorbance at about 256nm,with a suitable spectrophotometer,using 0.5Nhydrochloric 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 Cis the concentration,in µg per mL,of USP Phenmetrazine Hydrochloride RSin the Standard solution,and AUand ASare the absorbances from the Assay preparationand the Standard solution,respectively.
Auxiliary Information—
Staff Liaison:Daniel K.Bempong,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
USP28–NF23Page 1529
Phone Number:1-301-816-8143