USPNF section

Norethindrone Tablets

Type of Posting: 
Revision Bulletin
Targeted Official Date: 
01–Jun–2014
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 Norethindrone Tablets monograph. The purpose for the revision is to add Dissolution Test 3 for a drug product approved by the FDA.

The liquid chromatographic procedure used in Dissolution Test 3 is based on analyses performed with a Zorbax Exclipse XDB brand of L1 column manufactured by Agilent. The typical retention time for norethindrone is about 4 minutes.

Methylphenidate Hydrochloride Extended-Release Tablets

Type of Posting: 
Revision Bulletin
Targeted Official Date: 
01–Jun–2014
Expert Committee: 
Monograph—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 Methylphenidate Hydrochloride Extended-Release Tablets monograph. The purpose for the revision is to add a dissolution Test 3 and Test 4 to reflect products approved by the FDA.

The liquid chromatographic procedure in Dissolution Test 3 is based on analyses performed with Luna C18(2)-HST brand of L1 column manufactured by Phenomenex. The typical retention time for methylphenidate is about 1.8 min.

Levalbuterol Inhalation Solution

Type of Posting: 
Revision Bulletin
Targeted Official Date: 
01–Jun–2014
Expert Committee: 
Monographs—Small Molecules 4
Reason for Revision: 
Correction of test

In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs—Small Molecules 4 Expert Committee has revised the Levalbuterol Inhalation Solution monograph. The purpose for the revision is to eliminate the need for USP Levalbuterol Related Compound G RS, because USP is unable to maintain a reliable supply of the USP Levalbuterol Related Compound G RS which is utilized in the current test for Organic Impurities. In addition, the name in Table 3 of Organic Impurities test USP Levalbuterol Related Compound G has been replaced with 5-hydroxyalbuterol.

Omega-3-Acid Ethyl Esters

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

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—Dietary Supplements and Herbal Medicines Expert Committee, the Expert Committee responsible for monographs applicable to dietary supplements, herbal medicines, and certain drug products and drug substances, intends to revise the Omega-3-Acid Ethyl Esters monograph via an Interim Revision Announcement (IRA).

Omega-3-Acid Ethyl Esters Capsules

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

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—Dietary Supplements and Herbal Medicines Expert Committee, the Expert Committee responsible for monographs applicable to dietary supplements, herbal medicines, and certain drug products and drug substances, intends to revise the Omega-3-Acid Ethyl Esters Capsules monograph via an Interim Revision Announcement (IRA).

Monographs and General Chapters Affected by Revision to General Chapter <601> AEROSOLS, NASAL SPRAYS, METERED-DOSE INHALERS, AND DRY POWDER INHALERS

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

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 <601> Aerosols, Nasal Sprays, Metered-Dose Inhalers, and Dry Powder Inhalers.

Levalbuterol Inhalation Solution

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
Revision Bulletin; 01–Jun–2014
Expert Committee: 
Monographs—Small Molecules 4

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—Small Molecules 4 Expert Committee intends to revise the Levalbuterol Inhalation Solution monograph via a Revision Bulletin. USP is unable to maintain a reliable supply of the USP Levalbuterol Related Compound G RS utilized in the current test for Organic Impurities. The purpose of this revision is to eliminate the need for this Reference Standard. 

Ceftriaxone Injection

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
1–Aug–2014

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—Small Molecules 1 Expert Committee intends to revise the Ceftriaxone Injection monograph to eliminate cross-references to the Assay in the Ceftriaxone Sodium monograph and to present the complete, detailed procedure.

The revision will be published using the Errata process; the target posting date for the Errata is July 25, 2014 and the target official date is August 1, 2014.

Cefazolin Injection

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
1–Aug–2014
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 USP Monographs—Small Molecules 1 Expert Committee intends to revise the Cefazolin Injection monograph to eliminate cross-references to the Assay in the Cefazolin monograph and to present the complete, detailed procedure, which includes the use of the Internal Standard.

The revision will be published using the Errata process; the target posting date for the Errata is July 25, 2014 and the target official date is August 1, 2014.

Chlorhexidine Acetate

Type of Posting: 
Revision Bulletin
Targeted Official Date: 
01–April–2014
Expert Committee: 
Monographs—Small Molecules 3
Reason for Revision: 
Compliance
In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 3 Expert Committee has revised the Chlorhexidine Acetate monograph. The purpose for the revision is to omit the compendial use of USP Chlorhexidine Related Compounds RS.  USP has been unable to secure a replacement source for USP Chlorhexidine Related Compounds RS and the supply has been fully depleted.