Transcription of á232ñ ELEMENTAL IMPURITIES—LIMITS
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á232ñ ELEMENTAL IMPURITIES—LIMITS
Table 10 (Continued)Standard SolutionConcentration of Neu5Ac after Labeling(mM)Concentration of Neu5Gc after Labeling(mM) solution:Transfer a desalted sample containing approximately 50 mg of protein (equivalent to about 5 pmolof sialic acid) into a microcentrifuge tube. Dry in a vacuum centrifuge without heating. Add 25 mL of 2M aceticacid 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 15min. [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 11 USP N-Acetylneuraminic Acid RSUSP N-Glycolylneuraminic Acid RSUSP KDN RS3-Deoxy-D-glycero-D-galacto-2-nonuloso nic (USP40) 232 ELEMENTAL IMPURITIES LIMITSC hange to read:INTRODUCTIONThis chapter specifies limits for the amounts of ELEMENTAL impurities in drug products.
SPECIATION The determination of the oxidation state, organic complex, or combination is termed “speciation”. Each of the elemental impurities has the potential to be present in differing oxidation or complexation states.
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