Add the following:
Packaging and storage
Preserve in well-closed, light-resistant containers. Store at room temperature.NF24
Label it to indicate whether it is anhydrous or the monohydrate.
Specific rotation 781S:
, measured at 20
10 mg per mL in 6 N hydrochloric acid.
Microbial limits 61
The total aerobic microbial count does not exceed 1000 cfu per g, and the total combined molds and yeasts count does not exceed 100 cfu per g.
Loss on drying 731
Dry it at 130
for 3 hours: 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.
Prepare a Test Preparation
using a 1-g portion of Asparagine, and use 5 mL of Diluted Standard Lead Solution
(5 µg of Pb) for the test: the limit is 5 µg per g.
Change to read:
0.25-mm layer of chromatographic silica gel mixture.
10 mg per mL.
Prepare a solution of
USP Asparagine Anhydrous RS or USP Asparagine Monohydrate RSNF24
in water having a known concentration of about 0.05 mg per mL. [Note
Use USP Asparagine Anhydrous RS and USP Asparagine Monohydrate RS for the evaluation of the anhydrous and monohydrate forms of Asparagine, respectively.]NF24
Developing solvent system:
a mixture of butyl alcohol, water, and glacial acetic acid (3:1:1).
Dissolve 0.2 g of ninhydrin in 100 mL of a mixture of butyl alcohol and glacial acetic acid (95:5).
Proceed as directed for Thin-Layer Chromatography
under Chromatography 621
, and then dry the plate at 80
for 30 minutes. Spray the plate with the Spray reagent,
heat at 80
for 10 minutes, 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.
Dissolve about 130 mg of Asparagine, accurately weighed, in 3 mL of formic acid and 50 mL of glacial acetic acid, and titrate with 0.1 N perchloric acid VS (see Titrimetry 541
), determining the endpoint potentiometrically. Perform a blank determination, and make any necessary corrections. Each mL of 0.1 N perchloric acid is equivalent to 13.21 mg of C4
, calculated on the dried basis.
: Catherine Sheehan, B.Sc., Scientist
Expert Committee : (EM105) Excipient Monographs 1
USP29NF24 Page 3276
: Volume No. 31(1) Page 87
Phone Number : 1-301-816-8262