USPNF section

USP Monographs Will No Longer Cite Reference Standards Required by a General Chapter as of USP 41–NF 36

Type of Posting: 
General Announcement

For purposes of uniformity, starting with USP 41–NF 36 print and online editions, reference standards required by general chapters’ procedures will no longer be referenced in the USP Reference Standards <11> section of each monograph.  Such references will be contained in the applicable general chapters. The change will be presented in printed and online versions as it is indicated in the example below:

USP Reference Standards <11> 

USP XXXXX RS

<1xxx> Fc Function Assays

Type of Posting: 
General Chapter Prospectus
Expert Committee: 
Biologics Monographs 2—Proteins

Input Deadline: November 28, 2016

Proposed Title: Fc Function Assays

Suggested Audience: Biopharmaceutical industry, regulatory agencies, pharmaceutical scientists, biologists, immunologists, academicians and therapeutic drug manufacturers

Estimated proposal PF: 44(2) [Mar.–Apr. 2018]

Removal of 3D Chemical Structures in USP–NF Online

Type of Posting: 
General Announcement

USP recently discovered a technical issue in the USP–NF online product regarding the accessibility of the 3D Image chemical structures available in some monographs. The 3D image viewer is no longer compatible with the newest versions of Chrome and Internet Explorer that USP supports.

While we work to determine a solution for future online editions, we will be removing the 3D Image link from the USP–NF online product starting on November 1, 2016.

Addition of UNII Codes in USP 40–NF 35 Online

Type of Posting: 
General Announcement

This is a general announcement to alert users to the addition of UNII codes into the USP 40–NF 35 online product. UNII codes will appear in monographs which contain CAS information, displaying at the end of the chemical information section. Not every monograph will contain a UNII code, and some monographs may contain multiple UNII codes.

For example:

Update to Style for Latin Binomials in USP 40–NF 35

Type of Posting: 
General Announcement

For purposes of uniformity, starting with USP 40–NF 35 print and online editions, the style for Latin Binomials has been updated. This style change does not affect the content. A list of files affected by the restyled Latin Binomials can be found here.

Should you have any questions, please contact Hellen Oketch, Senior Scientific Liaison (301-230-3249 or hao@usp.org

Clean-up of General Chapter References in USP 40–NF 35

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
01–May–2017
Expert Committee: 
Various

In accordance with section 7.05(c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that USP and its Expert Committees, as applicable, intend to revise multiple monographs and General Chapters in response to revisions of General Chapters prior to the development of the current process for updating reference changes for General Chapters.

Monographs Affected by Revision to <821> Radioactivity

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
1–May–2017
Expert Committee: 
Various

In accordance with section 7.05(c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that USP and its Expert Committees, as applicable, intend to revise multiple monographs in response to the revision of General Chapter <821> Radioactivity.

Monographs Affected by Revision to <659> Packaging and Storage

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
1–May–2017
Expert Committee: 
Various

In accordance with section 7.05(c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that USP and its Expert Committees, as applicable, intend to revise multiple monographs in response to the revision of General Chapter <659> Packaging and Storage.

Monographs Affected by the Revision of <531> Thiamine Assay

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
1–May–2017
Expert Committee: 
Non-Botanical Dietary Supplements

In accordance with section 7.05(c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that the Non-Botanical Dietary Supplements Expert Committee intends to revise the Thiamine Hydrochloride Tablets monograph in response to the revision of General Chapter <531> Thiamine Assay.

Monographs Affected by the Revision of <481> Riboflavin Assay

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
1–May–2017
Expert Committee: 
Non-Botanical Dietary Supplements

In accordance with section 7.05(c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that the Non-Botanical Dietary Supplements Expert Committee intends to revise the Riboflavin Tablets and Riboflavin Injection monographs in response to the revision of General Chapter <481> Riboflavin Assay.