USPNF section

Levothyroxine Sodium Tablets

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
01–Sep–2016
Expert Committee: 
Chemical Medicines Monographs 3

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 3 Expert Committee intends to revise the Levothyroxine Sodium Tablets monograph.

Comments were received that indicate that a small amount of liothyronine in USP Levothyroxine RS may affect the results obtained for the Limit of Liothyronine Sodium test. The Expert Committee proposes to revise this test, to perform the quantitation using a new Liothyronine standard solution containing USP Liothyronine RS only.

Corticotropin Injection, Corticotropin for Injection, Repository Corticotropin Injection

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
Interim Revision Announcement; 1-July-2016
Expert Committee: 
Biologics Monographs 1–Peptides

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 Biologics Monographs 1–Peptides intends to revise the Corticotropin Injection, Corticotropin for Injection, Repository Corticotropin Injection monographs.

Aspartic Acid

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
01–Sep–2016
Expert Committee: 
Monographs—Non-Botanical Dietary Supplements Expert Committee

In accordance with section 7.04 (c) of the Rules and Procedures of the Council of Experts, this is to provide notice that the USP Monographs— Non-Botanical Dietary Supplements Expert Committee, the Expert Committee responsible for monographs applicable to dietary supplements, and certain drug products and drug substances, intends to revise the Aspartic Acid monograph via an Interim Revision Announcement (IRA).

Correction to FCC 9 Third Supplement Online: Appendix XIII: Adulterants and Contaminants in Food Ingredients, Pesticide Residues

Type of Posting: 
Publication Correction
USP recently determined that there was an omission in the Pesticide Residues section of Appendix XIII: Adulterants and Contaminants in Food Ingredients that is appearing in the FCC 9 Third Supplement online product.

Proposal Status/Commentary

USP posts the status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement.

Sodium Chloride

Type of Posting: 
Sodium Chloride Notice of Adoption of Harmonized Standard
Official Date: 
01–Dec–2016
Expert Committee: 
Excipient Monographs 2

Coordinating Pharmacopeia: European Pharmacopoeia

The revision to the harmonized standard for Sodium Chloride 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 Sodium Chloride monograph has been formally approved by the Excipient Monographs 2 Expert Committee in accordance with the Rules and Procedures of the Council of Experts.

This is to make a correction to the previous Stage 6 posting on November 21, 2014:

Povidone

Type of Posting: 
Notice of Adoption of Harmonized Standard
Official Date: 
01–Dec–2016
Expert Committee: 
Excipient Monographs 2

Coordinating Pharmacopeia: Japanese Pharmacopoeia

The revision to the harmonized standard for Povidone 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 Povidone monograph has been formally approved by the Excipient Monographs 2 Expert Committee in accordance with the Rules and Procedures of the Council of Experts.

Methylcellulose

Type of Posting: 
Notice of Adoption of Harmonized Standard
Official Date: 
01–Dec–2016
Expert Committee: 
Excipient Monographs 2

Coordinating Pharmacopeia: Japanese Pharmacopoeia

The revision to the harmonized standard for Methylcellulose 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 Methylcellulose monograph has been formally approved by the Excipient Monographs 2 Expert Committee in accordance with the Rules and Procedures of the Council of Experts.

Hypromellose 2015–11–20

Type of Posting: 
Notice of Adoption of Harmonized Standard
Official Date: 
01–Dec–2016
Expert Committee: 
Excipient Monographs 2

Coordinating Pharmacopeia: Japanese Pharmacopoeia

The correction to the harmonized standard for Hypromellose 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 Hypromellose monograph has been formally approved by the Excipient Monographs 2 Expert Committee in accordance with the Rules and Procedures of the Council of Experts.