| Monograph Title
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Monograph Section
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Scientific Liaison
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| <401> FATS AND FIXED OILS PF 32(5) Pg. 1492
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ACID VALUE (FREE FATTY ACIDS)
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| <466> ORDINARY IMPURITIES PF 32(5) Pg. 1493
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Introduction
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| <466> ORDINARY IMPURITIES PF 32(5) Pg. 1493
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REPORTING AND SPECIFICATIONS
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| <466> ORDINARY IMPURITIES PF 32(5) Pg. 1493
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METHODOLOGY
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| <466> ORDINARY IMPURITIES PF 32(5) Pg. 1493
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PROCEDURE
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| <467> ORGANIC VOLATILE IMPURITIES PF 32(5) Pg. 1494
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Title
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| <467> ORGANIC VOLATILE IMPURITIES PF 32(5) Pg. 1494
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INTRODUCTION
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| <467> ORGANIC VOLATILE IMPURITIES PF 32(5) Pg. 1494
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CLASSIFICATION OF RESIDUAL SOLVENTS BY RISK ASSESSMENT
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| <467> ORGANIC VOLATILE IMPURITIES PF 32(5) Pg. 1494
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METHODS FOR ESTABLISHING EXPOSURE LIMITS
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| <467> ORGANIC VOLATILE IMPURITIES PF 32(5) Pg. 1494
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OPTIONS FOR DESCRIBING LIMITS OF CLASS 2 RESIDUAL SOLVENTS
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| <467> ORGANIC VOLATILE IMPURITIES PF 32(5) Pg. 1494
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ANALYTICAL PROCEDURES
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| <467> ORGANIC VOLATILE IMPURITIES PF 32(5) Pg. 1494
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REPORTING LEVELS OF RESIDUAL SOLVENTS
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| <467> ORGANIC VOLATILE IMPURITIES PF 32(5) Pg. 1494
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LIMITS OF RESIDUAL SOLVENTS
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| <467> ORGANIC VOLATILE IMPURITIES PF 32(5) Pg. 1494
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IDENTIFICATION, CONTROL, AND QUANTIFICATION OF RESIDUAL SOLVENTS
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| <467> ORGANIC VOLATILE IMPURITIES PF 32(5) Pg. 1494
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GLOSSARY
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| <467> ORGANIC VOLATILE IMPURITIES PF 32(5) Pg. 1494
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Methods for establishing exposure limits
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| <467> ORGANIC VOLATILE IMPURITIES PF 32(5) Pg. 1494
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Analytical procedures
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| <621> CHROMATOGRAPHY PF 30(5) Pg. 1687
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System suitability
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| <621> CHROMATOGRAPHY PF 31(3) Pg. 825
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System Suitability (All revisions after the first two paragraphs, through the end up to Glossary)
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| <621> CHROMATOGRAPHY PF 32(4) Pg. 1163
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INTRODUCTION
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| <621> CHROMATOGRAPHY PF 32(4) Pg. 1163
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THIN-LAYER CHROMATOGRAPHY
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| <621> CHROMATOGRAPHY PF 32(4) Pg. 1163
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INTERPRETATION OF CHROMATOGRAMS
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| <621> CHROMATOGRAPHY PF 32(4) Pg. 1163
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SYSTEM SUITABILITY
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| <621> CHROMATOGRAPHY PF 32(4) Pg. 1163
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SYSTEM SUITABILITY
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| <621> CHROMATOGRAPHY PF 32(4) Pg. 1163
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CHROMATOGRAPHIC REAGENTS
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| <660> CONTAINERS -- GLASS PF 32(4) Pg. 1171
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Title
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| <660> CONTAINERS -- GLASS PF 32(4) Pg. 1171
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Introduction
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| <660> CONTAINERS -- GLASS PF 32(4) Pg. 1171
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CHEMICAL RESISTANCE
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| <661> CONTAINERS -- PLASTICS PF 32(4) Pg. 1176
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Title
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| <661> CONTAINERS -- PLASTICS PF 32(4) Pg. 1176
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Introduction
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| <661> CONTAINERS -- PLASTICS PF 32(4) Pg. 1176
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LIGHT TRANSMISSION
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| <661> CONTAINERS -- PLASTICS PF 32(4) Pg. 1176
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CHEMICAL RESISTANCE-GLASS CONTAINERS
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| <661> CONTAINERS -- PLASTICS PF 32(4) Pg. 1176
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BIOLOGICAL TESTS-PLASTICS AND OTHER POLYMERS
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| <661> CONTAINERS -- PLASTICS PF 32(4) Pg. 1176
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PHSYSICOCHEMICAL TESTS-PLASTIC
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| <661> CONTAINERS -- PLASTICS PF 32(4) Pg. 1176
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CONTAINERS FOR OPHTHALMICS-PLASTICS
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| <661> CONTAINERS -- PLASTICS PF 32(4) Pg. 1176
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POLYETHYLENE CONTAINERS
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| <661> CONTAINERS -- PLASTICS PF 32(4) Pg. 1176
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POLYETHYLENE TEREPHTHALATE BOTTLES AND POLYETHYLENE TEREPHTHALATE G BOTTLES
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| <661> CONTAINERS -- PLASTICS PF 32(4) Pg. 1176
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POLYPROPYLENE CONTAINERS
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| <661> CONTAINERS -- PLASTICS PF 32(4) Pg. 1176
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REPACKAGING INTO SINGLE-UNIT CONTAINERS AND UNIT-DOSE CONTAINERS FOR NONSTERILE SOLID AND LIQUID DOSAGE FORMS
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| <661> CONTAINERS -- PLASTICS PF 32(4) Pg. 1176
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CUSTOMIZED PATIENT MEDICATION PACKAGES
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| <661> CONTAINERS -- PLASTICS PF 32(4) Pg. 1176
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INTRODUCTION
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| <661> CONTAINERS -- PLASTICS PF 32(4) Pg. 1176
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POLYETHYLENE CONTAINERS
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| <661> CONTAINERS -- PLASTICS PF 32(4) Pg. 1176
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POLYPROPYLENE CONTAINERS
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| <661> CONTAINERS -- PLASTICS PF 32(4) Pg. 1176
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POLYETHYLENE TEREPHTHALATE BOTTLES AND POLYETHYLENE TEREPHTHALATE G CONTAINERS
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| <661> CONTAINERS -- PLASTICS PF 32(4) Pg. 1176
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TEST METHODS
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| <671> CONTAINERS--PERMEATION PF 32(4) Pg. 1193
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Title
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| <671> CONTAINERS--PERMEATION PF 32(4) Pg. 1193
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Introduction
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| <671> CONTAINERS--PERMEATION PF 32(4) Pg. 1193
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MULTIPLE-UNIT CONTAINERS FOR CAPSULES AND TABLETS
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| <671> CONTAINERS--PERMEATION PF 32(4) Pg. 1193
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MULTIPLE-UNIT CONTAINERS FOR CAPSULES AND TABLETS (WITHOUT CLOSURE)
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| <671> CONTAINERS--PERMEATION PF 32(4) Pg. 1193
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MULTIPLE-UNIT CONTAINERS AND UNIT-DOSE CONTAINERS FOR LIQUIDS
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| <671> CONTAINERS--PERMEATION PF 32(4) Pg. 1193
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LIGHT TRANSMISSION TEST
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| <681> REPACKAGING INTO SINGLE-UNIT CONTAINERS AND UNIT-DOSE CONTAINERS FOR NONSTERILE SOLID AND LIQUID DOSAGE FORMS PF 32(4) Pg. 1197
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Title
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| <681> REPACKAGING INTO SINGLE-UNIT CONTAINERS AND UNIT-DOSE CONTAINERS FOR NONSTERILE SOLID AND LIQUID DOSAGE FORMS PF 32(4) Pg. 1197
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Introduction
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| <681> REPACKAGING INTO SINGLE-UNIT CONTAINERS AND UNIT-DOSE CONTAINERS FOR NONSTERILE SOLID AND LIQUID DOSAGE FORMS PF 32(4) Pg. 1197
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CUSTOMIZED PATIENT MEDICATION PACKAGES
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| <721> DISTILLING RANGE PF 32(4) Pg. 1200
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METHOD II
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| <729> GLOBULE SIZE DISTRIBUTION IN LIPID INJECTABLE EMULSIONS PF 31(5) Pg. 1448
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Title
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| <729> GLOBULE SIZE DISTRIBUTION IN LIPID INJECTABLE EMULSIONS PF 31(5) Pg. 1448
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Introduction
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| <729> GLOBULE SIZE DISTRIBUTION IN LIPID INJECTABLE EMULSIONS PF 31(5) Pg. 1448
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Method I--Light-Scattering Method
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| <729> GLOBULE SIZE DISTRIBUTION IN LIPID INJECTABLE EMULSIONS PF 31(5) Pg. 1448
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Method II--Measurement of Large Globule Content by Light Obscuration or Extinction Method
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|
| <1086> IMPURITIES IN OFFICIAL ARTICLES PF 32(5) Pg. 1509
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INTRODUCTION
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| <1086> IMPURITIES IN OFFICIAL ARTICLES PF 32(5) Pg. 1509
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DEFINITIONS
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| <1086> IMPURITIES IN OFFICIAL ARTICLES PF 32(5) Pg. 1509
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INDUSTRIAL CONCEPTS
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| <1086> IMPURITIES IN OFFICIAL ARTICLES PF 32(5) Pg. 1509
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INITIAL IND FILING
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| <1086> IMPURITIES IN OFFICIAL ARTICLES PF 32(5) Pg. 1509
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NDA FILING
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| <1086> IMPURITIES IN OFFICIAL ARTICLES PF 32(5) Pg. 1509
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POST NDA APPROVAL
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| <1086> IMPURITIES IN OFFICIAL ARTICLES PF 32(5) Pg. 1509
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ANDA FILING
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| <1086> IMPURITIES IN OFFICIAL ARTICLES PF 32(5) Pg. 1509
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INITIAL IND FILING
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| <1086> IMPURITIES IN OFFICIAL ARTICLES PF 32(5) Pg. 1509
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NDA FILING
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| <1086> IMPURITIES IN OFFICIAL ARTICLES PF 32(5) Pg. 1509
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POST NDA APPROVAL
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| <1086> IMPURITIES IN OFFICIAL ARTICLES PF 32(5) Pg. 1509
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ANDA FILING
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| <1086> IMPURITIES IN OFFICIAL ARTICLES PF 32(5) Pg. 1509
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DEFINITIONS
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|
| <1120> RAMAN SPECTROPHOTOMETRY PF 32(4) Pg. 1211
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Title
|
|
| <1120> RAMAN SPECTROPHOTOMETRY PF 32(4) Pg. 1211
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INTRODUCTION
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| <1120> RAMAN SPECTROPHOTOMETRY PF 32(4) Pg. 1211
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QUALITATIVE AND QUANTITATIVE RAMAN MEASUREMENTS
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| <1120> RAMAN SPECTROPHOTOMETRY PF 32(4) Pg. 1211
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FACTORS AFFECTING QUANTIFICATION
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| <1120> RAMAN SPECTROPHOTOMETRY PF 32(4) Pg. 1211
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APPARATUS
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| <1120> RAMAN SPECTROPHOTOMETRY PF 32(4) Pg. 1211
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QUALIFICATION AND VERIFICATION OF RAMAN SPECTROMETERS
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| <1120> RAMAN SPECTROPHOTOMETRY PF 32(4) Pg. 1211
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METHOD VALIDATION
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| <1120> RAMAN SPECTROPHOTOMETRY PF 32(4) Pg. 1211
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DEFINITION OF TERMS AND SYMBOLS
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| <1121> NOMENCLATURE PF 32(4) Pg. 1228
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Introduction
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| <1121> NOMENCLATURE PF 32(4) Pg. 1228
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"SEC. 299.4 ESTABLISHED NAMES OF DRUGS."
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| <1121> NOMENCLATURE PF 32(4) Pg. 1228
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GENERAL NOMENCLATURE FORMS
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| <1163> QUALITY ASSURANCE IN PHARMACEUTICAL COMPOUNDING PF 32(5) Pg. 1517
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Title
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| <1163> QUALITY ASSURANCE IN PHARMACEUTICAL COMPOUNDING PF 32(5) Pg. 1517
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INTRODUCTION
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| <1163> QUALITY ASSURANCE IN PHARMACEUTICAL COMPOUNDING PF 32(5) Pg. 1517
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STANDARD OPERATING PROCEDURES
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| <1163> QUALITY ASSURANCE IN PHARMACEUTICAL COMPOUNDING PF 32(5) Pg. 1517
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DOCUMENTATION
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| <1163> QUALITY ASSURANCE IN PHARMACEUTICAL COMPOUNDING PF 32(5) Pg. 1517
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VERIFICATION
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| <1163> QUALITY ASSURANCE IN PHARMACEUTICAL COMPOUNDING PF 32(5) Pg. 1517
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TESTING
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| <1163> QUALITY ASSURANCE IN PHARMACEUTICAL COMPOUNDING PF 32(5) Pg. 1517
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MICROBIOLOGICAL TESTING
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| <1163> QUALITY ASSURANCE IN PHARMACEUTICAL COMPOUNDING PF 32(5) Pg. 1517
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SUMMARY
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|
| <1178> GOOD REPACKAGING PRACTICES PF 32(5) Pg. 1523
|
Introduction
|
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| <1178> GOOD REPACKAGING PRACTICES PF 32(5) Pg. 1523
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INTRODUCTION
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| <1178> GOOD REPACKAGING PRACTICES PF 32(5) Pg. 1523
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DEFINITIONS
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| <1178> GOOD REPACKAGING PRACTICES PF 32(5) Pg. 1523
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ESTABLISHING EXPIRATION DATE
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| <1178> GOOD REPACKAGING PRACTICES PF 32(5) Pg. 1523
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REFERENCES FOR REPACKAGING REGULATIONS AND GUIDANCES
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|
| <1226> VERIFICATION OF COMPENDIAL METHODS PF 31(2) Pg. 555
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Title
|
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| <1226> VERIFICATION OF COMPENDIAL METHODS PF 31(2) Pg. 555
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Introduction
|
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| <1226> VERIFICATION OF COMPENDIAL METHODS PF 31(2) Pg. 555
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Verification Process
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| <1226> VERIFICATION OF COMPENDIAL METHODS PF 31(2) Pg. 555
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Analytical Performance Characteristics
|
|
| <1226> VERIFICATION OF COMPENDIAL METHODS PF 32(4) Pg. 1232
|
Introduction
|
|
| <1226> VERIFICATION OF COMPENDIAL METHODS PF 32(4) Pg. 1232
|
VERIFICATION PROCESS
|
|
| <1226> VERIFICATION OF COMPENDIAL METHODS PF 32(4) Pg. 1232
|
ANALYTICAL PERFORMANCE CHARACTERISTICS
|
|
| <1226> VERIFICATION OF COMPENDIAL METHODS PF 32(4) Pg. 1232
|
Introduction
|
|
| <1226> VERIFICATION OF COMPENDIAL METHODS PF 32(4) Pg. 1232
|
VERIFICATION PROCESS
|
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| <1226> VERIFICATION OF COMPENDIAL METHODS PF 32(4) Pg. 1232
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VERIFICATION REQUIREMENTS
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|
| <1231> WATER FOR PHARMACEUTICAL PURPOSES PF 32(5) Pg. 1528
|
TYPES OF WATER
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|
