U.S. PHARMACOPEIA

Search USP29  
Commentary

Commentary —Revision proposals published in Pharmacopeial Forum often elicit public comments that are forwarded to the appropriate Expert Committee for review and response. Some revision proposals can advance to official status with minor modifications, as needed, without requiring further public review. In such cases a summary of comments received and the Committee's responses are published in the Commentary section of the Supplement or annual edition in which the revision becomes official. For those proposals that require further revision and republication in Pharmacopeial Forum, a summary of the comments and the Committee's responses will be included in the briefing that accompanies each article.
The Commentary section is not part of the official text of the monograph. Rather, it explains the basis of the Committee's response to public comments. If there is a difference between the contents of the Commentary section and the official monograph, the text of the official monograph prevails. In case of a dispute or question of interpretation, the language of the official text, alone and independent of the Commentary section, shall prevail.
Where appropriate, the Commentary section includes a separate discussion of proposals related to international harmonization of the USP, the European Pharmacopoeia, and the Japanese Pharmacopoeia in order to highlight such proposals.

MONOGRAPH COMMENTARY FOR USP 29–NF 24
Carbomer Homopolymer (new monograph) and revisions to Carbomer Copolymer, Carbomer Interpolymer, and Carbomer 934, 934P, 940, 941, and 1342 monographs:
A new monograph for Carbomer Homopolymer introduces a compendial standard for carbomers that are manufactured without the use of benzene and, as a result, are able to meet a stringent limit of benzene (not more than 2 ppm). The test for the limit of benzene, with the same stringent limit, also is added to existing monographs for Carbomer Copolymer and Carbomer Interpolymer, which also are manufactured without the use of benzene. The labeling changes in the carbomer monographs are to ensure that benzene-manufactured carbomers could not be labeled as Carbomer Homopolymer or Carbomer Copolymer.
The monographs for carbomers manufactured with benzene, such as Carbomer 934, 934P, 940, 941, and 1342, will remain in the compendium; the expectation is that in the future, the use of benzene will cease entirely, these products will be discontinued, and the corresponding monographs will be omitted from USP–NF.
Title for the new Carbomer Homopolymer monograph will become official January 1, 2011. Prior to January 1, 2011, the current practice of labeling the article of commerce with the name Carbomer 934, Carbomer 934P, Carbomer 940, or Carbomer 941, whichever is appropriate, may be continued. Use of the name Carbomer Homopolymer would be permitted as of January 1, 2006, the official date of USP 29–NF 24, but the use of this name would not become mandatory until January 1, 2011. The 60-months extension is intended to allow for the product label changes to be made and for health practitioners and consumers to become familiar with the terminology.

GENERAL CHAPTER COMMENTARY FOR USP 29–NF 24
Chromatography 621— The Pharmaceutical Analysis 2 Expert Committee agreed to include a Quantitation Limit Solution as part of the system suitability test for chromatographic purity or related compounds tests. The objective of this procedure is to ensure that under the test conditions, the system is able to detect and quantitate impurities in low concentrations.
Comments received expressed concerns regarding the impact of this practice in older monographs, but the Expert Committee considers that it is critical to demonstrate sensitivity during system suitability testing. In particular for impurity tests, the user must be able to demonstrate that the system can measure the analyte at the appropriate level.
In order to give enough time to update standard operating procedures and to correct potential inconsistencies the implementation date for this revision will be June 1, 2006