USPNF section

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: 
TBD
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.
The process for and timing of the re

Clarithromycin

Type of Posting: 
Notice Intent to Revise
Targeted Official Date: 
TBD
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. 
 
The process for and timing of the revision will be determined following additional consideration by the Expert Committee and USP staff. 
 
Should you have any questions, please c

Clarithromycin Tablets

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
TBD
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 Tablets monograph to specify regions of the chromatogram that are to be disregarded when reporting results. 
 
The process for and timing of the revision will be determined following additional consideration by the Expert Committee and USP staff. 
 
Should you have any questions,

Allopurinol

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
Revision Bulletin, 01–Jun–2015
Expert Committee: 
Monographs—Small Molecules 3
In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs—Small Molecules 3 Expert Committee intends to revise the Allopurinol monograph. The purpose for the revision is to eliminate the use of USP Allopurinol Related Compound F RS under the test for Organic Impurities.

Correction to USP 37–NF 32 Second Supplement and USP 38–NF 33 Online Publications

Type of Posting: 
Publication Correction

USP recently determined there were accelerated revision icons incorrectly associated with five reagents affecting both the USP 37–NF 32 Second Supplement online publication (posted on June 1, 2014 and official December 1, 2014) and the USP 38-NF 33 online publication (posted on November 1, 2014 to become official on May 1, 2015). There are no accelerated revisions associated with these reagents.

The affected reagents and publications are:

USP 37–NF 32 Second Supplement Online -

Menthol

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
Revision Bulletin, 01–Jun–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 Monographs—Dietary Supplements and Herbal Medicines Expert Committee intends to revise Menthol monograph.

Comments and data received shows that menthol obtained from natural sources does not meet the current limit of 0.1% for Individual impurities indicated in the monograph. The Expert Committee intends to increase the limit for Individual impurities to 0.3% based on the data submitted to USP.

Telmisartan and Hydrochlorothiazide Tablets

Type of Posting: 
Revision Bulletin
Official Date: 
01–Apr–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 Telmisartan and Hydrochlorothiazide Tablets monograph. The purpose of the revision is to include Dissolution Test 2 to be consistent with the FDA approved specifications.
 
The HPLC procedure in Dissolution Test 2 is based on analyses performed using an Inertsil ODS-3V brand of L1 column.

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.