USP Monograph Development Process and Compendial Updates

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Residual Solvents• Organic Volatile Impurities– USP XXII, 9 th supp. (1993)– Only 4 solvents are tested (Class 2)– Chapter referenced in specific monographs• Residual Solvents– Intent to align with ICH Q3C (1997)– 59 solvents• Subsequent revisions– PF 32(5) [Sept-Oct 2006]– IRA in PF 33(3) [May-June 2007]– Latest updates – PF 34(3) [May-June 2008]; target officialpublication is the First Supplement to USP32-NF27
Residual Solvents• Testing of drug substances, excipients, and drugproducts for residual solvents should be performedwhen production or purification processes areknown to result in the presence of such residualsolvents.• It is only necessary to test for residual solvents thatare used or produced in the manufacture orpurification processes.• Solvent used or produced in the final manufacturingstep and solvents that are used or produced inearlier manufacturing steps and not removedconsistently by a validated process.
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Quality Standards for Medicines, Su
Page 4 and 5: United States PharmacopeialConventi
Page 6 and 7: Legal Recognition1848 Drug Import A
Page 9 and 10: 2005-2010 Council of ExpertsFood Ad
Page 11 and 12: 2005-2010 Expert Committee Demograp
Page 13 and 14: Why a USP-NF Monograph?• Recogniz
Page 15 and 16: Submission Information on Web Site
Page 17: USP Standards Setting ProcessMonogr
Page 20 and 21: Role of USP Expert Committees• Ev
Page 22 and 23: Flexible Monographs: Examples• Et
Page 24 and 25: Flexible Monograph ExampleTheophyll
Page 26 and 27: USP PublicationsFood Chemicals Code
Page 28 and 29: USP Reference Standards
Page 30 and 31: USP RS Development Process1. Create
Page 32 and 33: Compendial Updates
Page 34 and 35: Monograph Redesign• Well defined
Page 36 and 37: Monograph Redesign
Page 38 and 39: General Notices Redesign• Ease of
Page 40 and 41: General Notices Revision• Timelin
Page 42 and 43: Major Issues for Phase II• Issues
Page 44 and 45: Pending Monographs• Sponsors- Who
Page 46 and 47: PF Redesign• Current situation- D
Page 48 and 49: PF Redesign• Remove official text
Page 50 and 51: PF Redesign• Redesign USP-NF Web
Page 52 and 53: PF Redesign• September 2008: ASM
Page 56 and 57: Residual Solvents• Classes of res
Page 58 and 59: Educational Activities• Residual
Page 60 and 61: Heavy Metals• USP is actively see
Page 62 and 63: Compendial Toolshttp://www.usp.org/
Page 64 and 65: Column Equivalency
Page 66: Quality Standards for Medicines, Su
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USP Monograph Development Process and Compendial Updates

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