USPNF section

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.

Stimuli to the Revision Process: Proposed New USP General Chapter: The Analytical Procedure Lifecycle <1220>

Type of Posting: 
General Announcement
Expert Committee: 
General Chapters—Chemical Analysis

The General Chapters—Chemical Analysis Expert Committee is currently developing a new general chapter <1220> The Analytical Procedure Lifecycle. The purpose of this new chapter will be to more fully address the entire procedure lifecycle and define concepts that may be useful.

Polysorbate 80

Type of Posting: 
Notice of Adoption of Harmonized Standard
Official Date: 
01–Aug–2017
Expert Committee: 
Excipient Monographs 2
Coordinating Pharmacopoeia: 
European Pharmacopoeia

The revision to the harmonized standard for Polysorbate 80 has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG sign-off cover sheet. Having reached Stage 6 of the PDG process, the Polysorbate 80 monograph has been formally approved by the Excipient Monographs 2 Expert Committee in accordance with the Rules and Procedures of the Council of Experts.

Changes from the existing USP–NF monograph include:

Cellulose Acetate

Type of Posting: 
Notice of Adoption of Harmonized Standard
Targeted Official Date: 
01–Aug–2017
Expert Committee: 
Excipient Monographs 2
Coordinating Pharmacopoeia: 
United States Pharmacopoeia

The revision to the harmonized standard for Cellulose Acetate has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG sign-off cover sheet. Having reached Stage 6 of the PDG process, the Cellulose Acetate monograph has been formally approved by the Excipient Monographs 2 Expert Committee in accordance with the Rules and Procedures of the Council of Experts.

Changes from the existing USP–NF monograph include:

<1236> Solubility Measurements

Type of Posting: 
General Chapter Prospectus
Expert Committee: 
General Chapters–Physical Analysis

Input Deadline: October 31, 2016

Suggested audience: Suppliers and manufactures of excipients, drug substances, drug products, veterinary products and regulatory agencies.

Estimated proposal PF: 43(2) [Mar.–Apr. 2017]

Background and objectives: 

USP Expert Panel on Medical Cannabis

USP invites qualified candidates to apply to serve as scientific experts on the Medical Cannabis Expert Panel. The purpose of this Expert Panel is to develop quality standards for cannabis used for medical purposes. The Expert Panel will make recommendations to and work at the direction of the Botanical Dietary Supplements and Herbal Medicines Expert Committee. Candidates interested in sharing their time and expertise should have in-depth knowledge of:

General Chapter Prospectus: Tablet Breaking Force <1217>

Type of Posting: 
General Chapter Prospectus
Expert Committee: 
General Chapters—Dosage Forms

Input Deadline: October 15, 2016

Suggested audience: Tablet breaking force test apparatus manufacturers, tablet press manufacturers

Estimated proposal PF: 43(2) [Mar.–May 2017]

Background and objective(s):  <1217> Tablet Breaking Force was proposed as a new General Chapter in 2005 and has been part of USP official text since 2007. The General Chapters—Dosage Forms Expert Committee is planning a major revision of this General Chapter, as part of the cycle of reviews.

Topiramate

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
Interim Revision Announcement, 01–May–2017
Expert Committee: 
Chemical Medicines Monographs 4

In accordance with section 7.04(c) of the 2015–2020 Rules and Procedures of the Council of Experts, this is to provide notice that the Chemical Medicines Monographs 4 Expert Committee intends to revise the Topiramate monograph.

Based on the comments received, the Expert Committee proposed the following revisions.

Correction for USAN 2016

Type of Posting: 
Publication Correction

USP recently determined that there is an error in the entry for Eletriptan Hydrobromide that appears in USAN 2016 Online. In the following CAS image, "HCl" should be "HBr".

Incorrect image:

USAN Incorrect image