Add the following:
Asparagine
;)
L-Asparagine
L-a-Aminosuccinamic acid,monohydrate [5794-13-8].
Anhydrous 132.12 [70-47-3].
»Asparagine is anhydrous,or contains one molecule of water of hydration.It contains not less than 98.0percent and not more than 101.5percent of C4H8N2O3,as L-asparagine,calculated on the dried basis.
Labeling—
Label it to indicate whether it is anhydrous or the monohydrate.
USP Reference standards á11ñ—
USP Asparagine RS.
Identification:
Infrared Absorption á197Kñ.
Specific rotation á781Sñ:
between +33.0
and +36.5,measured at 20.
and +36.5,measured at 20.
Test solution:
10mg per mLin 6Nhydrochloric acid.
Microbial limits á61ñ—
The total aerobic microbial count does not exceed 1000cfu per g,and the total combined molds and yeasts count does not exceed 100cfu per g.
Loss on drying á731ñ—
Dry it at 130for 3hours:the anhydrous form loses not more than 1.0%of its weight,and the monohydrate loses between 11.5%and 12.5%of its weight.
for 3hours:the anhydrous form loses not more than 1.0%of its weight,and the monohydrate loses between 11.5%and 12.5%of its weight.
Residue on ignition á281ñ:
not more than 0.1%,determined on 1.0g.
Lead á251ñ—
Prepare a Test Preparationusing a 1-g portion of Asparagine,and use 5mLof Diluted Standard Lead Solution(5µg of Pb)for the test:the limit is 5µg per g.
Chromatographic purity—
Adsorbent:
0.25-mm layer of chromatographic silica gel mixture.
Test solution:
10mg per mL.
Standard solution—
Prepare a solution of USP Asparagine RSin water having a known concentration of about 0.05mg per mL.
Application volume:
5µL.
Developing solvent system:
a mixture of butyl alcohol,water,and glacial acetic acid (3:1:1).
Spray reagent—
Dissolve 0.2g of ninhydrin in 100mLof a mixture of butyl alcohol and glacial acetic acid (95:5).
Procedure—
Proceed as directed for Thin-Layer Chromatographyunder Chromatography á621ñ,and then dry the plate at 80for 30minutes.Spray the plate with the Spray reagent,heat at 80for 10minutes,and examine under white light:no secondary spot in the chromatogram obtained from the Test solution is larger or more intense than the principal spot in the chromatogram obtained from the Standard solution(0.5%);and not more than 1.0%of total impurities is found.
for 30minutes.Spray the plate with the Spray reagent,heat at 80for 10minutes,and examine under white light:no secondary spot in the chromatogram obtained from the Test solution is larger or more intense than the principal spot in the chromatogram obtained from the Standard solution(0.5%);and not more than 1.0%of total impurities is found.
Assay—
Dissolve about 130mg of Asparagine,accurately weighed,in 3mLof formic acid and 50mLof glacial acetic acid,and titrate with 0.1Nperchloric acid VS(see Titrimetry á541ñ),determining the endpoint potentiometrically.Perform a blank determination,and make any necessary corrections.Each mLof 0.1Nperchloric acid is equivalent to 13.21mg of C4H8N2O3,calculated on the dried basis.NF23
NF23
Auxiliary Information—
Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 2959
Pharmacopeial Forum:Volume No.30(1)Page 205
Phone Number:1-301-816-8251