Wednesday, 13 November 2013

Updates to United States Pharmacopeia

The 1st Supplement to USP36-NF31 has recently been issued. Updates of interest are:

Biological Tests and Assays

Chapter 87 - Biological Reactivity Tests. In Vitro

Changes to the following sections: Introduction, Cell Culture Preparation, Agar Diffusion Test, Direct Contact Test, and Elution Test

Chapter 88 - Biological Reactivity Tests, In Vivo

Changes to the following sections: Introduction, Classification of Plastics, Extracting Media, Systemic Injection Test, Intracutaneous Test, Implantation Test, and Safety Test—Biologicals.

Physical Tests and Determinations

Chapter 643 - Total Organic Carbon

Changes to: Introduction, Bulk Water and addition of Sterile Water section.

Chapter 645 - Water Conductivity

Changes to sample collection procedure for Sterile Water.

General Information

 Chapter 1031 - The Biocompatibility of Materials Used in Drug Containers, Medical Devices and Implants

Introduction; In Vitro Testing, In Vivo Testing, and Class Designation for Plastics and Other Polymers; Biocompatibility of Medical Devices and Implants; and Guidance in Selecting the Plastic or Other Polymer Class Designation for a Medical Device
Chapter 1118 - Monitoring Devices – Time, Temperature and Humidity

The general information chapter has been re-written and the devices described in this chapter are those most commonly used to monitor the controlled storage and established distribution of drug products following Good Distribution Practices (GDP).

In addition, some further sterilization chapters have been produced:

Chapter 1229 - Sterilisation of Compendial Articles [NEW]
Chapter 1229.1 - Steam Sterilisation by Direct Contact [NEW]
Chapter 1229.2 - Moist Heat Sterilisation of Aqueous Liquids [NEW]

There has also been an update to the chapter relating to water:

Chapter 1231 - Water for Pharmaceutical Purposes

Types of water, Chemical Considerations

The 2nd Supplement to USP36-NF31 is shortly to be issued. Items of interest here include:

Apparatus for Tests and Assays

Chapter 16 - Automated Methods of Analysis. This chapter has been deleted.

General Information

 Chapter 1030 - Biological Assay Chapters – Overview and Glossary [NEW]

Chapter 1034 - Analysis of Biological Assays - Appendix–Glossary, Glossary, and Glossary References added.

The USP–NF is a single–volume combination of two official compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). Monographs for drug substances and preparations are featured in the USP. Excipient monographs are in the NF.

Posted by Tim Sandle