| Upcoming Revisions to USP 30–NF 25, First Supplement |
Scientific Liaison |
<1> INJECTIONS
USP 29–NF 24 1S p. 3590
PF 32(2) p. 402
LABELS AND LABELING (Labeling; Aluminum in Large Volume Injections (LVIs), Small Volume Injections (SVIs), and Pharmacy Bulk Packages (PBPs) Used in Total Parenteral Nutrition (TPN) Therapy)
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<1> INJECTIONS
USP 29–NF 24 1S p. 3590
PF 32(2) p. 402
PACKAGING (Printing on Ferrules and Cap Overseals, Packaging and Storage )
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<11> USP REFERENCE STANDARDS
USP 29–NF 24 1S Pg. 3591
PF 32(2) Pg. 407
Introduction
Authentic Visual Reference
Other Reference Substances
Current Lots
Authority for Establishment and Release
History
Nomenclature
Diversity and Implications
Uses of USP Reference Standards
Steps in Establishing a USP Reference Standard
Collaborative Study for the Evaluation of a USP RS Candidate Material
Biological Reference Standards
Suitability for Use and Purity Assignment
Label Text
USP Reference Standards Expert Committee
Packaging
Impurity Reference Standards
Continued Suitability for Use Program
Proper Use
Storage
Relationships with Other Standards-setting Organizations
USP Reference Standards Specified in USP and NF Monographs and General Chapters
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<311> ALGINATES ASSAY
USP 29–NF 24 p. 2562
PF 32(2) p. 516
System suitability
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<611> ALCOHOL DETERMINATION
USP 29–NF 24 p. 2637
PF 32(3) p. 830
Method II—Gas-Liquid Chromatographic Method
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<730> PLASMA SPECTROCHEMISTRY
USP 29–NF 24 p. 2700
PF 32(3) p. 836
Introduction
Sample Preparation
Sample Introduction
Standard Preparation
ICP
ICP–AES
ICP–MS
Glossary
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<785> OSMOLALITY AND OSMOLARITY
USP 29–NF 24 p. 2718
PF 32(3) p. 850
Osmolarity
Measurement of Osmolality
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<921> Water Determination
USP 28, p. 2510
PF 31(2), p. 517
Method I (Titrimetric)
Method Ia (Direct Titration)
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<1047> BIOTECHNOLOGY-DERIVED ARTICLES--TESTS
USP 29 p.2858
PF 32(2) p.516
Title (delete)
Introduction (delete)
Amino Acid Analysis (delete)
Capillary Electrophoresis (delete)
Isoelectric Focusing (delete)
Peptide Mapping (delete)
Polyacrylamide Gel Electrophoresis (delete)
TOTAL PROTEIN ASSAY (delete)
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<1052> BIOTECHNOLOGY-DERIVED ARTICLES -- AMINO ACID ANALYSIS (new)
PF 32(2) p. 542
Title
Introduction
Introduction
Apparatus
General Precautions
Reference Standard Material
Calibration of Instrumentation
Repeatability
Sample Preparation
Internal Standards
Protein Hydrolysis
Methodologies of Amino Acid Analysis
Data Calculation and Analysis
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<1053> BIOTECHNOLOGY-DERIVED ARTICLES -- CAPILLARY ELECTROPHORESIS (new)
PF 32(2) p. 559
Title
Introduction
Introduction
General Principle
Apparatus
Free Solution Capillary Electrophoresis
Capillary Gel Electrophoresis
Capillary Isoelectric Focusing
Micellar Electrokinetic Chromatography (MEKC)
Capillary Electrophoresis System Suitability
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<1054> BIOTECHNOLOGY-DERIVED ARTICLES -- ISOELECTRIC FOCUSING (new)
PF 32(2) p. 568
Title
Introduction
Introduction
General Principles
Apparatus
Procedure
Specified Variations to the General Method
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<1055> BIOTECHNOLOGY-DERIVED ARTICLES -- PEPTIDE MAPPING (new)
PF 32(2) p. 571
Title
Introduction
Introduction
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<1056> BIOTECHNOLOGY-DERIVED ARTICLES -- POLYACRYLAMIDE GEL ELECTROPHORESIS (new)
PF 32(2) p. 580
Title
Introduction
Introduction
General Principle of Electrophoresis
Characteristics of Polyacrylamide Gels for Protein Electrophoresis
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<1057> BIOTECHNOLOGY-DERIVED ARTICLES -- TOTAL PROTEIN ASSAY (new)
PF 32(2) p. 589
Title
Introduction
Introduction
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<1065> ION CHROMATOGRAPHY
USP 29–NF 24 p. 2898
PF 32(3) p. 899
Apparatus
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<1070> EMERGENCY MEDICAL SERVICES VEHICLES AND AMBULANCES -- STORAGE OF PREPARATIONS (new)
PF 32(2) p. 605
Title
Introduction
Pharmaceutical Storage Cabinet Monitoring; Location of Parked Vehicles
Stock Rotation
Portable Carrying Case Storage and Monitoring
Additional Requirements for Some Articles
Storage and Handling of Sensitive Preparations
Use of Time–Temperature Indicators
Composite Inventory of Typical Ambulance Service Medications (delete)
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<1080> BULK PHARMACEUTICAL EXCIPIENTS--CERTIFICATE OF ANALYSIS (new)
PF 31(4) p. 1167
Title
Background
General Guidance
Design and Suggested Elements of a Certificate of Analysis
Certificate of Analysis Template
Compendial Designation
Dates on a Certificate of Analysis
Testing Frequency
Use of Electronic Signatures
Distributor Information
Appendix 1-- Definitions
Appendix 2-- State of Statistical Control: Process Capability Parameters For Determining Levels of Control
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<1118> MONITORING DEVICES--TIME, TEMPERATURE, AND HUMIDITY
USP 29–NF 24 p. 2976
PF 32(3) p. 900
Electronic Time–Temperature History Recorders
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<1184> SENSITIZATION TESTING (new)
PF 30(1) p. 289
Title
Introduction
Magnusson & Kligman guinea pig maximization test
Standard Buehler tests
Other sensitization test procedures
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<1208> STERILITY TESTING--VALIDATION OF ISOLATOR SYSTEMS
USP 28, p. 2735
PF 30(6), p. 2162
Introduction
Isolator Design and Construction
Validation of the Isolator System
Package Integrity Verification
Maintenance of Asepsis Within the Isolator Environment
Interpretation of Sterility Test Results
Training and Safety
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<1217> TABLET BREAKING FORCE (new)
PF 31(6) p. 1695
Title
Introduction
Tablet breaking force determinations
Tensile strength
References
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<1222> TERMINALLY STERILIZED PHARMACEUTICAL PRODUCTS-PARAMETRIC RELEASE
USP 28, p. 2746
PF 30(5), p. 1741
Introduction
General review
Modes of sterilization
Summary
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