USPNF section

Stearic Acid

Type of Posting: 
Notice of Adoption of Harmonized Standard
Official Date: 
01–May–2016
Expert Committee: 
Monographs—Excipients
Coordinating Pharmacopoeia: 
EP
A revision to the harmonized standard for Stearic Acid has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 6 Rev. 1 Corr. 1 Sign-Off Cover Page.

Sodium Lauryl Sulfate

Type of Posting: 
Notice of Adoption of Harmonized Standard
Official Date: 
01–May–2016
Expert Committee: 
Monographs—Excipients
Coordinating Pharmacopoeia: 
USP
A new harmonized standard for Sodium Lauryl Sulfate has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 6 Sign-Off Cover Page.

Saccharin Sodium

Type of Posting: 
Notice of Adoption of Harmonized Standard
Official Date: 
01–May–2016
Expert Committee: 
Monographs—Excipients
Coordinating Pharmacopoeia: 
USP
A revision to the harmonized standard for Saccharin Sodium has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 6 Rev. 2 Sign-Off Cover Page.

Polysorbate 80

Type of Posting: 
Notice of Adoption of Harmonized Standard
Official Date: 
01–May–2016
Expert Committee: 
Monographs—Excipients
Coordinating Pharmacopoeia: 
European Pharmacopoeia
A revision to the harmonized standard for Polysorbate 80 has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 6 Corr. 2 Sign-Off Cover Page.

Monographs and General Chapters Affected by Revision to General Chapter <659> Packaging and Storage Requirements

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
01–Aug–2016
Expert Committee: 
General Chapters—Packaging, Storage and Distribution
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 the revision of General Chapter <659> Packaging and Storage Requirements.

Methocarbamol Tablets

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
Revision Bulletin (Postponement), 01–May–2015; Interim Revision Announcement, 01–Jan–2016
Expert Committee: 
Monographs—Small Molecules 4
In accordance with section 7.05(c) of the Rules and Procedures of the Council of Experts, this is to provide notice that the USP Monographs—Small Molecules 4 Expert Committee intends to revise the Methocarbamol Tablets monograph.

Methocarbamol

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
Revision Bulletin (Postponement), 01–May–2015; Interim Revision Announcement, 01–Jan–2016
Expert Committee: 
Monographs—Small Molecules 4
In accordance with section 7.05(c) of the Rules and Procedures of the Council of Experts, this is to provide notice that the USP Monographs—Small Molecules 4 Expert Committee intends to revise the Methocarbamol monograph.

Protamine Sulfate Injection

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
Revision Bulletin, 01–June–2015; Interim Revision Announcement, 01–Jan–2016
Expert Committee: 
Monographs—Biologics & Biotechnology 1
In accordance with section 7.05 (c) of the Rules and Procedures of the Council of Experts, this is to provide notice that the Monographs—Biologics & Biotechnology 1 Expert Committee intends to revise the Protamine Sulfate Injection monograph based on comments received.  
 
It is proposed to omit specification for the pH test in this monograph via a Revision Bulletin.

Piperacillin and Tazobactam for Injection

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
01–Aug–2015, Revision Bulletin
Expert Committee: 
Monographs—Small Molecules 1
In accordance with section 7.05 (c) of the Rules and Procedures of the Council of Experts, this is to provide notice that the USP Monographs—Small Molecules 1 Expert Committee intends to revise the Piperacillin and Tazobactam for Injection monograph as follows:
 
  1. The limits in the test for Organic Impurities Procedure 3 will be revised to reflect FDA-approved acceptance criteria.
  2. The concentrations of the standards in the Stock standard solution in Organic Impurities Procedure 4 will be corrected.
It is anticipated that the proposed

Clarithromycin

Type of Posting: 
Notice Intent to Revise
Targeted Official Date: 
01–Aug–2015; Revision Bulletin
Expert Committee: 
Monographs —Small Molecules 1
In accordance with section 7.05 (c) of the Rules and Procedures of the Council of Experts, this is to provide notice that the USP Monographs—Small Molecules 1 Expert Committee intends to revise the test for Organic Impurities in the Clarithromycin monograph to specify regions of the chromatogram that are to be disregarded when reporting results. 
 
It is anticipated that the proposed revision will be published as a Revision Bulletin on July 31, 2015 and become official on August 1, 2015, pursuant to section 7.02 of the Rules and Procedures.
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