USPNF section

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.

Edetate Calcium Disodium

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

The harmonized standard for Edetate Calcium Disodium has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG sign-off cover sheet. Having reached Stage 6 of the PDG process, the Edetate Calcium Disodium 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.

Dehydrated Alcohol

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 Dehydrated Alcohol has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 6 Rev. 2 Corr. 2 sign-off cover sheet. Having reached Stage 6 of the PDG process, the Dehydrated Alcohol 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.

Alcohol

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 Alcohol has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 6 Rev. 2 Corr. 2 sign-off cover sheet. Having reached Stage 6 of the PDG process, the Alcohol 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.

Telmisartan 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 Telmisartan Tablets monograph. The purpose of this revision is to include Dissolution Test 2 to accommodate the FDA approved Tolerances for a new dosage form.

The HPLC procedure in Dissolution Test 2 is based on analyses performed using a 5 μm Inertsil ODS 3V brand of L1 column. The typical retention time for telmisartan is about 6 min.