Apparatus for Tests and Assays
Chapter 21 Thermometers [This has been deleted]
Biological Tests and Assays
Chapter 162 Diphtheria Antitoxin Potency Testing for Human Immune Globulins [This is a new chapter]
An in vitro method is provided that is suitable for determining the potency of diphtheria antitoxin (antibodies against the diphtheria toxin) in preparations of plasma-derived human immune globulins. Diphtheria toxin is produced by Corynebacterium diphtheriae and has the ability to produce a cytopathogenic effect on susceptible epithelial cell lines. The test is based on the ability of diphtheria antitoxin to neutralize the diphtheria toxin, decreasing its cytotoxic effect. Specifically, the test determines the potency of the diphtheria antitoxin based on its ability to inhibit the cytotoxic effect of diphtheria toxin on cultured Vero cells (African green monkey kidney epithelial cells) relative to a reference standard. The mitochondrial dehydrogenases of live Vero cells can reduce the dye 3-4,5-dimethylthiazol-2-yl)-2,5 diphenyl tetrazolium bromide (MTT) to a blue/black product that is then measured by absorbance at 540 nm. If no or little diphtheria antitoxin is present, then diphtheria toxin induces cell death and the inability of cells to reduce MTT, resulting in the presence of white or colorless wells. Acceptance criteria are defined by the appropriate regulatory agencies.
With the 1 st supplement (effective 1 st August 2016):
Chapter 87 Biological Reactivity Tests, In Vitro
Test Control and USP Reference Standards
Chemical Tests and Assays
Chapter 191 Identification Tests-General
Introduction, Chemical Identification Tests, and Instrumental Identification Tests
Chapter 507 Protein Determination Procedures [New chapter]
Physical Tests and Determinations
Chapter 791 pH
Introduction, Instrument Requirements, Buffer Solutions for Calibration of the pH Measurement System, Calibration, and Operation.
Chapter 1035 Biological Indicators for Sterilisation [Chapter deleted]
Chapters added:
1207 Package Integrity Evaluation- Sterile Products
1207.1 Package Integrity Testing in the Product Life Cycle – Test Method Selection and Validation
1207.2 Package Integrity Leak Test Technologies
1207.3 Package Seal Quality Test Technologies
1228 Depyrogenation
1228.1 Dry Heat Depyrogenation
1229.5 Biological Indicators for Sterilisation
1229.9 Physicochemical Integrators and Indicators for Sterilisation
1229.12 New Sterilisation Methods
Chapters deleted:
1209 Sterilisation- Chemical and Physicochemical Indicators and Integrators
With the 2 nd supplement (effective on 1 st December 2016):
General Information
1029 Good Documentation Guidelines{ New chapter]
1228.3 Depyrogenation by Filtration [New chapter]
1228.5 Endotoxin Indicators for Depyrogenation [New chapter]
1229.13 Sterilisation-in-Place [New chapter]
1231 Water for Pharmaceutical Purposes [revise chapter]
