Transcription of 467 RESIDUAL SOLVENTS - USP-NF
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467 RESIDUAL SOLVENTS - USP-NF
467 RESIDUAL SOLVENTS1. OF RESIDUAL SOLVENTS BY RISK ASSESSMENT3. CONTROL STRATEGY4. LIMITS OF RESIDUAL Class 1: SOLVENTS to Be Class 2: SOLVENTS to Be Class 3: SOLVENTS with Low Toxic Potential5. OPTIONS FOR DESCRIBING LIMITS OF CLASS 2 AND CLASS 3 RESIDUAL Option 1 Concentration Option 2 Summation of Components Content6. REPORTING LEVELS OF RESIDUAL SOLVENTS7. IDENTIFICATION, CONTROL, AND QUANTIFICATION OF RESIDUAL Class 1 and Class 2 RESIDUAL Class 3 RESIDUAL Solvents8. ANALYTICAL PROCEDURES FOR CLASS 1 AND CLASS 2 RESIDUAL Chromatographic Screening of Water-Soluble Screening of Water-Insoluble Limit Tests When SOLVENTS LTBP Are Quantitative Tests Procedure C9.
Sep 27, 2019 · produced in the manufacturing of drug substances, excipients, or dietary ingredients, or in the preparation of drug products or dietary supplement products. Appropriate selection of the solvent for the synthesis of a drug substance or an excipient may enhance the yield or determine characteristics such as crystal form, purity, and solubility.
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