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Add the following: ELEMENTAL IMPURITIES— …
www.usp.orgRevision Bulletin 2 〈232〉 Elemental Impurities—Limits Official February 1, 2013 DRUG SUBSTANCE AND EXCIPIENTS The values provided in Table 2 represent concentration limits for components (drug substances and excipients) of
á232ñ ELEMENTAL IMPURITIES—LIMITS - USP
www.usp.orgSPECIATION 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.