USPNF section

<1054> Isoelectric Focusing

Expert Committee: 
Biologics & Biotechnology: Proteins and Polysaccharides
Coordinating Pharmacopoeia: 
EP

A harmonized standard for Isoelectric Focusing has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Sign-Off Cover Page. Since there was no web posting at the time of sign-off of this chapter, all previous PDG sign-offs and Stage 6 postings are summarized as below:

General Chapter Prospectus: <1099> Limit on Number of Large Deviations when Assessing Content Uniformity in Large Samples

Type of Posting: 
General Announcement
Expert Committee: 
General Chapters—Statistics

Input Deadline: March 24, 2017

Suggested audience: Pharmaceutical manufacturers, statisticians, regulatory professionals

Estimated proposal PF: Pharmacopeial Forum 43(4) [Jul.–Aug. 2017]

Clindamycin Phosphate

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
To Be Determined
Expert Committee: 
Chemical Medicines Monographs 1

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 1 Expert Committee intends to revise the Clindamycin Phosphate monograph.

Call for Candidates: Biologics Monographs—4 Antibiotics Expert Committee

Type of Posting: 
General Announcement
Closing Date: 
Extended 9–June–2017
Expert Committee: 
Council of Experts

In accordance with Section 4.01 of the Rules and Procedures of the 205-2020 Council of Experts, USP invites qualified candidates to apply to serve as scientific experts on the recently established Biologics Monographs 4—Antibiotics Expert Committee. This new Expert Committee will guide USP’s ongoing scientific efforts to update monograph requirements and associated reference standards for antibiotics that are currently still assessed and potency-assigned by antimicrobial activity.

USP Expert Panel on Probiotics

Type of Posting: 
General Announcement

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

Early Input Sought on Proposed <1912> Measurement of Hardness of Semisolids

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

Input/Comment Deadline: 31–May–2017 (comment deadline for PF 43(2) [Mar.–Apr. 2017])

Background and objective(s):

USP is requesting early input from stakeholders on a new proposed General Chapter <1912> Measurement Harness of Semisolids which will be published for comment in PF 43(2) [Mar.–Apr. 2017].

Early Input Sought on Proposed <915> Measurement of Structural Strength of Semisolids by Penetrometry

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

Input/Comment Deadline: 31–May–2017 (comment deadline for PF 43(2) [Mar.–Apr. 2017])

Background and objective(s):

USP is requesting early input from stakeholders on a new proposed General Chapter <915> Measurement of Structural Strength of Semisolds by Penetromety, which will be published for comment in Pharmacopeial Forum 43(2) [Mar.–Apr. 2017].

General Chapter <797> Pharmaceutical Compounding—Sterile Preparations will be Posted for Second Round of Public Comments

Type of Posting: 
General Announcement

General Chapter <797> is currently undergoing revision. Initially, the proposed chapter revision was published for public comment from September 25, 2015 to January 31, 2016. During the public comment period, USP received more than 8,000 comments from more than 2,500 stakeholders. The Compounding Expert Committee is currently evaluating all of the information received in the public comments and using these data to inform the chapter revision as appropriate.

Valine

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
01–Sep–2017, Interim Revision Announcement
Expert Committee: 
Non-Botanical Dietary Supplements

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 Non-Botanical Dietary Supplements Expert Committee intends to revise the Valine monograph.

The Expert Committee proposes to revise the Valine monograph with a new, improved High Performance Liquid Chromatographic (HPLC) procedure developed by the USP laboratories for the Related Compounds test to replace the current HPLC procedure that has been postponed due to compliance issues.

Pyridostigmine Bromide Tablets

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
01–Sep–2017, Interim Revision Announcement
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 Pyridostigmine Bromide Tablets monograph.

The Expert Committee proposes to revise the limits for specified and total impurities in the Organic Impurities section to be consistent with FDA approved acceptance criteria.