USPNF section

Raloxifene Hydrochloride Tablets

Type of Posting: 
Revision Bulletin
Official Date: 
01–Apr–2015
Expert Committee: 
Monographs—Small Molecules 4
Reason for Revision: 
Compliance
In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs- Small Molecules 4 Expert Committee has revised the Raloxifene Hydrochloride Tablets monograph. The purpose for the revision is to add Dissolution Test 2 for a drug product approved by the FDA.  
 
The liquid chromatographic procedure used in Dissolution Test 2 is based on analyses performed with a Symmetry C18 brand of L1 column manufactured by Waters.

Paroxetine Extended-Release Tablets

Type of Posting: 
Revision Bulletin
Official Date: 
01–Apr–2015
Expert Committee: 
Monographs—Small Molecules 4
Reason for Revision: 
Compliance
In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs—Small Molecules 4 Expert Committee has revised the Paroxetine Extended-Release Tablets monograph. The purpose for the revision is to add Dissolution Test 2 to reflect products approved by the FDA.
 
The liquid chromatographic procedure used for the analysis of the Acid stage sample solution in Dissolution Test 2 is based on analyses performed with a Hypersil-BDS C18 brand of L1 column manufactured by Thermo Scientific.

Over-the-Counter Standards

USP aims to establish public quality standards for all Over-the-Counter (OTC) medicines bearing the U.S. Food and Drug Administration's (FDA) Generally Recognized as Safe and Effective (GRASE) designation that come to market through the FDA's development and approval process.

Digoxin

Type of Posting: 
Intent to Revise
Targeted Official Date: 
01–Nov–2015
Expert Committee: 
Monographs—Dietary Supplements and Herbal Medicines

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 Dietary Supplements and Herbal Medicines Expert Committee intends to revise the Digoxin monograph to replace Procedure 1: Related glycosides with a new quantitative HPLC procedure that does not require USP Gitoxin RS. USP will be unable to supply USP Gitoxin RS due to the discontinuation of supply.

Powdered Digitalis

Type of Posting: 
Intent to Revise
Targeted Official Date: 
01–Nov–2015
Expert Committee: 
Monographs—Dietary Supplements and Herbal Medicines

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 Dietary Supplements and Herbal Medicines Expert Committee intends to revise the Powdered Digitalis monograph to replace Identification B. Procedure by Thin-Layer Chromatography with a new HPLC procedure that does not require USP Gitoxin RS. USP will be unable to supply USP Gitoxin RS due to the discontinuation of supply.

Monographs Affected by Revision to General Chapter <191> Identification Tests – General

Type of Posting                     Reference Changes
 
Posting Date                          16–Mar–2015
 
Targeted Official Date           01–Aug–2016 
 
Expert Committee                 General Chapters—Chemical Analysi

Chapter <87> Biological Reactivity, In Vitro

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
Interim Revision Announcement; 01–Nov–2015
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 the General Chapters—Packaging, Storage, and Distribution Expert Committee intends to revise General Chapter <87> Biological Reactivity, In Vitro.

Potassium Citrate Extended-Release Tablets

Type of Posting: 
Revision Bulletin
Official Date: 
01–Feb–2015
Expert Committee: 
Monographs—Dietary Supplements and Herbal Medicines
Reason for Revision: 
Compliance
In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs—Dietary Supplements and Herbal Medicines Expert Committee has revised the Potassium Citrate Extended-Release Tablets monograph. The purpose for the revision is to revise the Definition section to be consistent with the labeling information for Potassium Citrate Extended-Release Tablets approved by FDA and to add Dissolution Test 2 for drug product approved by the FDA.

Oxycodone Hydrochloride Oral Solution

Type of Posting: 
Revision Bulletin
Official Date: 
01–Feb–2015
Expert Committee: 
Monographs—Small Molecules 2
Reason for Revision: 
Compliance
In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs—Small Molecules 2 Expert Committee has revised the Oxycodone Hydrochloride Oral Solution monograph.

Ketorolac Tromethamine Tablets

Type of Posting: 
Revision Bulletin
Official Date: 
01–Feb–2015
Expert Committee: 
Monographs—Small Molecules 2
Reason for Revision: 
Compliance
In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs—Small Molecules 2 Expert Committee has revised the Ketorolac Tromethamine Tablets monograph.