USPNF section

Moexipril Hydrochloride and Hydrochlorothiazide Tablets

Type of Posting: 
Revision Bulletin
Targeted Official Date: 
01–Dec–2014
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 Moexipril Hydrochloride and Hydrochlorothiazide Tablets monograph. The purpose of the revision is to widen the acceptance criteria for several impurities listed below under the Organic Impurities section to be consistent with the FDA approved specifications.

Beta Carotene

Type of Posting: 
Revision Bulletin
Targeted Official Date: 
01–Dec–2014
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 Beta Carotene monograph. The purpose for the revision is to lower the specification for the all-trans-beta carotene content from NLT 95.0% to NLT 95% (no decimal figure) stated in the Definition section and in the Acceptance criteria of the test for Content of Beta Carotene. Other revisions were also made to resolve compliance issues.

Sesame Oil

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
Interim Revision Announcement, 01–Jul–2015
Expert Committee: 
Monographs—Excipients

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 USP Monographs—Excipients Committee intends to revise the Sesame Oil monograph.

Comments with supporting data were received that indicate the Specific Gravity specification should be revised. The Expert Committee proposes to revise the Specific Gravity lower limit from "0.916" to "0.912". The Expert Committee also proposes to update the monograph to accommodate a special grade that is used in injectable dosage forms.

Aluminum Sulfate and Calcium Acetate for Topical Solution

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
Interim Revision Announcement, 01–Jul–2015
Expert Committee: 
Monographs—Small Molecules 1
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 Monographs—Small Molecules 1 Expert Committee intends to revise the Aluminum Sulfate and Calcium Acetate for Topical Solution monograph.
 
The purpose of this revision is to correct the calculation error in the Assay for Aluminum sulfate tetradecahydrate.

General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
TBD
Expert Committee: 
Compounding

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 Compounding Expert Committee intends to republish General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings in the Pharmacopeial Forum (PF). The revised proposal is tentatively projected to be published in Pharmacopeial Forum 41(2) [Mar.–Apr. 2015].

Monographs and General Chapters Affected by Revision to General Chapter <851> Spectrophotometry and Light-Scattering

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
01–May–2016
Expert Committee: 
General Chapters—Chemical Analysis
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 omission of General Chapter <851> Spectrophotometry and Light-Scattering.

Rice Starch

Rice Starch
Type of Posting: 
Notice of Adoption of Harmonized Standard
Official Date: 
01–Aug–2015
Expert Committee: 
Monographs—Excipients

Coordinating Pharmacopoeia:  European Pharmacopoeia

Mannitol

Mannitol
Type of Posting: 
Notice of Adoption of Harmonized Standard
Official Date: 
01–Aug–2015
Expert Committee: 
Monographs—Excipients

Coordinating Pharmacopoeia:  European Pharmacopoeia

<616> Bulk Density and Tapped Density of Powders

<616> Bulk Density and Tapped Density of Powders
Type of Posting: 
Notice of Adoption of Harmonized Standard
Official Date: 
01–Aug–2015
Expert Committee: 
General Chapters—Physical Analysis

Coordinating Pharmacopoeia:  European Pharmacopoeia

A revision to the harmonized standard for Bulk Density and Tapped Density of Powders has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Rev. 3 sign-off cover sheet. Having reached Stage 6 of the PDG process, the general chapter of Bulk Density and Tapped Density of Powders has been formally approved by the USP General Chapters—Physical Analysis Expert Committee in accordance with the Rules and Procedures of the 2010–2015 Council of Experts.

Niacin Extended-Release Tablets

Niacin Extended-Release Tablets
Type of Posting: 
Revision Bulletin
Official Date: 
01–Oct–2014
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 Expert Committee has revised the Niacin Extended-Release Tablets monograph. The purpose for this revision is to add Dissolution Test 2 for a drug product approved by the FDA. Additionally, minor editorial changes have been made to update the monograph to current USP style.