USP Monograph Development Process and Compendial Updates

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Flexible <strong>Monograph</strong>s: Examples• Ethinyl Estradiol Drug Substance• Loratadine Drug Substance• Meloxicam Drug Substance• Paroxetine Drug Substance• Potassium Chloride Extended-Release Tablets• Theophylline Extended-Release Capsules
Flexible <strong>Monograph</strong> ExampleLoratadine drug substanceLabeling—If a test for Related compounds other than Test 1 is used,then the labeling states with which Related compoundstest the article complies.Related compounds—NOTE—On the basis of the synthetic route, perform eitherTest 1 or Test 2. Test 2 is recommended if 4,8-dichloro-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-one is a potential related compound.TEST 1—…TEST 2—…
Page 1 and 2: 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 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 54 and 55: Residual Solvents• Organic Volat
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

USP Monograph Development Process and Compendial Updates

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