USP美国药典 232 元素杂质-限度.pdfVIP

Accessed from 10.6.1.1 by yezk3ntgp on Tue May 23 21:15:04 EDT 2017 First Supplement to USP 40–NF 35 Chemical Tests / á232ñ Elemental Impurities—Limits 8065 Table 10 (Continued) Concentration of Neu5Ac after Labeling Concentration of Neu5Gc after Labeling Standard Solution (mM) (mM) 4 0.2 0.01 5 0.4 0.02 Sample solution: Transfer a desalted sample containing approximately 0.5–50 mg of protein (equivalent to about 5 pmol of sialic acid) into a 0.5-mL microcentrifuge tube. Dry in a vacuum centrifuge without heating. Add 25 mL of 2 M acetic acid into the tube and briefly centrifuge to ensure all of the sample is in the well of the tube. Incubate at 80° for 2 h ± 15 min. [NOTE—Or use validated sample preparation and time/temperature ranges.] Allow the tube to cool to room temper- ature for approximately 10 min. Then vortex and centrifuge. Label the solution as directed in Labeling before analysis. • USP REFERENCE STANDARDS á11ñ USP N-Acetylneuraminic Acid RS USP N-Glycolylneuraminic Acid RS USP KDN RS 3-Deoxy-D-glycero-D-galacto-2-nonulosonic acid. 1S (USP40) á232ñ ELEMENTAL IMPURITIES—LIMITS Change to read: INTRODUCTION This chapter specifies limits for the amounts of elemental impu