Phenylalanine
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L-Phenylalanine.
L-Phenylalanine [63-91-2].
»Phenylalanine contains not less than 98.5percent and not more than 101.5percent of C9H11NO2,as L-phenylalanine,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed containers.
Identification,
Infrared Absorption á197Kñ.
pHá791ñ:
between 5.4and 6.0,in a solution (1in 100).
Loss on drying á731ñ—
Dry it at 105
for 3hours:it loses not more than 0.3%of its weight.
for 3hours:it loses not more than 0.3%of its weight.
Residue on ignition á281ñ:
not more than 0.4%.
Chloride á221ñ—
A0.73-g portion shows no more chloride than corresponds to 0.50mLof 0.020Nhydrochloric acid (0.05%).
Sulfate á221ñ—
A0.33-g portion shows no more sulfate than corresponds to 0.10mLof 0.020Nsulfuric acid (0.03%).
Iron á241ñ:
0.003%.
Heavy metals,Method IIá231ñ:
0.0015%.
Chromatographic purity—
Adsorbent:
0.25-mm layer of chromatographic silica gel mixture.
Diluent—
Prepare a mixture of glacial acetic acid and water (50:50).
Test solution—
Dissolve an accurately weighed quantity of Phenylalanine in Diluentto obtain a solution having a concentration of 10mg per mL.Apply 5µL.
Standard solution—
Dissolve an accurately weighed quantity of USPL-Phenylalanine RSin Diluentto obtain a solution having a known concentration of about 0.05mg per mL.Apply 5µL.[NOTE—This solution has a concentration equivalent to about 0.5%of that of the Test solution.]
System suitability solution—
Prepare a solution in Diluentcontaining 0.4mg each of USPL-Phenylalanine RSand USPL-Tyrosine RSper mL.Apply 5µL.
Spray reagent—
Dissolve 0.2g of ninhydrin in 100mLof a mixture of butyl alcohol and 2Nacetic acid (95:5).
Developing solvent system—
Prepare a mixture of butyl alcohol,glacial acetic acid,and water (60:20:20).
Procedure—
Proceed as directed for Thin-Layer Chromatographyunder Chromatography á621ñ.After air-drying the plate,spray with Spray reagent,and heat between 100and 105for about 15minutes.Examine the plate under white light.The chromatogram obtained from the System suitability solutionexhibits two clearly separated spots.Any secondary spot in the chromatogram obtained from the Test solutionis not larger or more intense than the principal spot in the chromatogram obtained from the Standard solution:not more than 0.5%of any individual impurity is found;and not more than 2.0%of total impurities is found.
and 105for about 15minutes.Examine the plate under white light.The chromatogram obtained from the System suitability solutionexhibits two clearly separated spots.Any secondary spot in the chromatogram obtained from the Test solutionis not larger or more intense than the principal spot in the chromatogram obtained from the Standard solution:not more than 0.5%of any individual impurity is found;and not more than 2.0%of total impurities is found.
Organic volatile impurities,Method Iá467ñ:
meets the requirements.
Assay—
Transfer about 160mg of Phenylalanine,accurately weighed,to a 125-mLflask,dissolve in a mixture of 3mLof formic acid and 50mLof glacial acetic acid,and titrate with 0.1Nperchloric acid VS,determining the endpoint potentiometrically.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 16.52mg of C9H11NO2.
Auxiliary Information—
Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 1538
Phone Number:1-301-816-8389