USPNF section

Levocetirizine Dihydrochloride

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
01–Sep–2017, Interim Revision Announcement
Expert Committee: 
Chemical Medicines Monographs 5

In accordance with section 7.04(c) of the 2015–2020 Rules and Procedures of the Council of Experts, this is to provide notice that the Chemical Medicine Monographs 5 Expert Committee intends to revise the Levocetirizine Dihydrochloride monograph.

Based on comments received, the Expert Committee proposes to replace the liquid chromatographic procedure in the test for Enantiomeric Purity with a different liquid chromatographic procedure to improve the reproducibility and robustness of the analysis.

<1382> Assessment of Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems

Type of Posting: 
General Chapter Prospectus
Expert Committee: 
General Chapters—Packaging and Storage
Input Deadline: January 30, 2017
 
Suggested audience: Drug product manufacturers using elastomeric component with a packaging system 
 
Estimated proposal Pharmacopeial Forum:  PF 43(3) [May–Jun.

<1381> Evaluation of Elastomeric Components Used in Pharmaceutical Packaging/Delivery Systems

Type of Posting: 
General Chapter Prospectus
Expert Committee: 
General Chapters—Packaging and Storage
Input Deadline: January 30, 2017
 
Suggested audience: Suppliers of elastomeric materials and components used for packaging systems (primary packaging components) and drug product manufacturers using elastomeric component and system primary containers
 
Estimated proposal Pharmacopeial Forum:  PF 43(3) [May–Jun.

<382> Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems

Type of Posting: 
General Chapter Prospectus
Expert Committee: 
General Chapters—Packaging and Storage
Input Deadline: January 30, 2017
 
Suggested audience: Drug product manufacturer using elastomeric component with a packaging system 
 
Estimated proposal Pharmacopeial Forum:  PF 43(3) [May–Jun.

<381> Elastomeric Closure for Injections

Type of Posting: 
General Chapter Prospectus
Expert Committee: 
General Chapters—Packaging and Storage
Input Deadline: January 30, 2017
 
Suggested audience: Suppliers of elastomeric materials and components used for packaging systems (primary packaging components) and drug product manufacturers using elastomeric component and system primary containers
 
Estimated proposal Pharmacopeial Forum:  PF 43(3) [May–Jun.

<87> Biological Reactivity, In Vitro, <88> Biological Reactivity, In Vivo, and <1031> The Biocompatibility of Materials used in Drug Containers, Medical Devices and Implants

Type of Posting: 
General Chapter Prospectus
Expert Committee: 
General Chapters—Biological Analysis
Input Deadline: January 30, 2017
 
Suggested Audience: Suppliers and users of elastomeric and plastic materials and components used in medical devices and packaging systems (primary packaging components) for drug product.
 
Estimated proposal Pharmacopeial Forum:  PF 43(5) [Sep.–Oct.

Theophylline Oral Solution

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
Revision Bulletin, 01–Feb–2017
Expert Committee: 
Chemical Medicines Monographs 5

In accordance with section 7.04(c) of the 2015–2020 Rules and Procedures of the Council of Experts, this is to provide notice that the Chemical Medicines Monographs 5 Expert Committee intends to revise the Theophylline Oral Solution monograph.

Based on a comment received, the Expert Committee proposes to make the following change to the test of Organic impurities:

Promethazine Hydrochloride Oral Solution

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
Revision Bulletin, 01–Feb-2017
Expert Committee: 
Chemical Medicines Monographs 5

In accordance with section 7.04(c) of the 2015–2020 Rules and Procedures of the Council of Experts, this is to provide notice that the Chemical Medicine Monographs 5 Expert Committee intends to revise the Promethazine Hydrochloride Oral Solution monograph.

Based on a comment received, the Expert Committee proposes to make the following change to the test of Organic impurities:

USP Monographs Will No Longer Cite Reference Standards Required by a General Chapter as of USP 41–NF 36

Type of Posting: 
General Announcement

For purposes of uniformity, starting with USP 41–NF 36 print and online editions, reference standards required by general chapters’ procedures will no longer be referenced in the USP Reference Standards <11> section of each monograph.  Such references will be contained in the applicable general chapters. The change will be presented in printed and online versions as it is indicated in the example below:

USP Reference Standards <11> 

USP XXXXX RS

<1xxx> Fc Function Assays

Type of Posting: 
General Chapter Prospectus
Expert Committee: 
Biologics Monographs 2—Proteins

Input Deadline: November 28, 2016

Proposed Title: Fc Function Assays

Suggested Audience: Biopharmaceutical industry, regulatory agencies, pharmaceutical scientists, biologists, immunologists, academicians and therapeutic drug manufacturers

Estimated proposal PF: 44(2) [Mar.–Apr. 2018]