USP美国药典 233元素杂质-检查法.pdfVIP

Accessed from 10.6.1.1 by yezk3ntgp on Tue May 23 21:21:37 EDT 2017 298 á233ñ Elemental Impurities—Procedures / Chemical Tests USP 40 á233ñ ELEMENTAL IMPURITIES—PROCEDURES INTRODUCTION This chapter describes two analytical procedures (Procedures 1 and 2) for the evaluation of the levels of the elemental impuri- ties. The chapter also describes criteria for acceptable alternative procedures. By means of validation studies, analysts will confirm that the analytical procedures described herein are suitable for use on specified material. Use of Alternative Procedures The chapter also describes criteria for acceptable alternative procedures. Alternative procedures that meet the validation re- quirements herein may be used in accordance with General Notices and Requirements 6.30, Alternative and Harmonized Meth- ods and Procedures. Information on the Requirements for Alternate Procedure Validation is provided later in this chapter. Speciation The determination of the oxidation state, organic complex, or combination is termed speciation. Analytical procedures for spe- ciation are not included in this chapter, but examples may be found elsewhere in USP–NF and in the literature. PROCEDURES • COMPENDIAL PROCEDURES 1 AND 2 System standardization and suitability evaluation using applicable reference materials should be performed on the day of analysis. s Procedure and detection technique: Procedure 1 can be used for elemental impurities generally amenable to detection by r e inductively coupled plasma–atomic (optical) emission spectroscopy (ICP–AES or ICP–OES). Procedure 2 can be used for ele- t p mental impurities generally amenable to detection by ICP–MS. Before