Tuesday, 21 June 2016

USP #39 update


USP39-NF34 became official on 01 May 2016.

Items of interest include:

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 1st supplement (effective 1st 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 2nd supplement (effective on 1st 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]



Posted by Dr. Tim Sandle