USPNF section

Trazodone Hydrochloride

Type of Posting: 
Revision Bulletin
Official Date: 
01–Feb–2015
Expert Committee: 
Monographs—Small Molecules 4
Reason for Revision: 
Safety
In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs—Small Molecules 4 Expert Committee has revised the Trazodone Hydrochloride monograph. The purpose for the revision is to remove USP Trazodone Hydrochloride RS from the Standard solution within the test for the Limit of Trazodone Related Compound F and Cyclophosphamide Related Compound A. 
 
The intended purpose of the test is to quantify trazodone related compound F and cyclophosphamide related compound A.

General Notices Section 5.60.30 Elemental Impurities in USP Drug Products and Dietary Supplements

Type of Posting: 
Notice of Intent to Revise
Expert Committee: 
Council of Experts Executive 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 Council of Experts Executive Committee (CoE EC) intends to revise General Notices Section 5.60.30 Elemental Impurities in USP Drug Products and Dietary Supplements to more closely align the implementation date of Elemental Impurities standards with that of the ICH Q3D Guideline for Elemental Impurities, thus establishing an implementation date of January 1, 2018 for General Chapters <232> Elemental Impurities–Limits and <2232> El

General Chapter <231> Heavy Metals and Affected Monographs and General Chapters

Type of Posting: 
Notice of Intent to Revise
Expert Committee: 
Various
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 the omission date of General Chapter <231> Heavy Metals and the references to this General Chapter in multiple monographs and general chapters.
 
On December 27, 2013, USP announced that General Chapters <232> Elemental Impurities—Limits and <2232> Elemental Contaminants in Dietary Supplements would be made applicable to all drug products (<

Open-Microphone Web Meeting for General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings

Type of Posting: 
General Announcement
Expert Committee: 
Compounding
In December 2014, the Compounding Expert Committee republished General Chapter <800> due to the nature and significance of the comments received on the original Pharmacopeial Forum (PF) proposal.  The General Chapter, which was originally published in PF 40(3) [May–Jun. 2014], provides standards to protect personnel and the environment when handling hazardous drugs.

Amoxicillin

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
To be determined
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 test for Organic Impurities in the Amoxicillin monograph to include a limit for amoxicillin D-hydroxyphenylglycyl ester.
 
It is anticipated that the proposed revision will be published as an In-Process Revision at a date yet to be determined, pursuant to section 7.02 of the Rules and Procedures.
 
Should you have any questi

Proposed Revisions to the General Notices and Requirements to be Published for Comment in Pharmacopeial Forum 41(1) [Jan.–Feb. 2015]

Type of Posting: 
General Announcement
Targeted Official Date: 
01–May–2016
Expert Committee: 
Council of Experts Executive Committee

To provide additional time for review and input, USP is posting in advance the proposed General Notices and Requirements (GN) section of the United States Pharmacopeia and the National Formulary (USP–NF) that will be published for public notice and comment in Pharmacopeial Forum 41(1) [Jan.–Feb. 2015]. GN is regularly revised to refine and clarify its content. GN was most recently revised in the Second Supplement to USP 37–NF 32 (published June 1, 2014; official December 1, 2014).

Methylcellulose

Type of Posting: 
Notice of Adoption of Harmonized Standard
Targeted Official Date: 
01–Dec–2015
Expert Committee: 
Monographs—Excipients
Coordinating Pharmacopoeia: 
Japanese Pharmacopoeia

The correction to harmonized standard for Methylcellulose has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 6 Corr. 1 sign-off cover sheet. Having reached Stage 6 of the PDG process, the Methylcellulose monograph has been formally approved by the USP Monographs—Excipients Expert Committee in accordance with the Rules and Procedures of the 2010–2015 Council of Experts.

Sodium Chloride

Type of Posting: 
Notice of Adoption of Harmonized Standard
Targeted Official Date: 
01–Dec–2015
Expert Committee: 
Monographs—Excipients
Coordinating Pharmacopoeia: 
European Pharmacopoeia

A revision to the harmonized standard for Sodium Chloride has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 6 Rev. 3 Sign-Off Cover Page. Having reached Stage 6 of the PDG process, the Sodium Chloride monograph has been formally approved by the USP Monographs—Excipients Expert Committee in accordance with the Rules and Procedures of the 2010–2015 Council of Experts.

<1056> Biotechnology-Derived Articles—Polyacrylamide Gel Electrophoresis

Type of Posting: 
Notice of Adoption of Harmonized Standard
Targeted Official Date: 
01–Dec–2015
Expert Committee: 
General Chapters—Biological Analysis
Coordinating Pharmacopoeia: 
European Pharmacopoeia

A revision to the harmonized standard for Polyacrylamide Gel Electrophoresis has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 6 Rev. 1 Sign-Off Cover Page. Having reached Stage 6 of the PDG process, the Polyacrylamide Gel Electrophoresis General Chapter has been formally approved by the General Chapters—Biological Analysis Expert Committee in accordance with the Rules and Procedures of the 2010–2015 Council of Experts.

Hypromellose

Type of Posting: 
Notice of Adoption of Harmonized Standard
Targeted Official Date: 
01–Dec–2015
Expert Committee: 
Monographs—Excipients
Coordinating Pharmacopoeia: 
Japanese Pharmacopoeia

The correction to harmonized standard for Hypromellose has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 6 Corr. 1 sign-off cover sheet. Having reached Stage 6 of the PDG process, the Hypromellose monograph has been formally approved by the USP Monographs—Excipients Expert Committee in accordance with the Rules and Procedures of the 2010–2015 Council of Experts.