USP Forms Working Group on HPLC Column

The United States Pharmacopeia (USP) is pleased to announce that it has formed a USP Working Group on HPLC Columns. The group, which consists of members from the USP Expert Committee on Pharmaceutical Analysis 2, the National Institute of Standards and Technology (NIST), and major column manufacturers, is charged with creating categories in order to subclassify the USP designation L1 for C18 (octadecyl silane) HPLC columns. The subclassification of the L1 columns is meant to help facilitate the selection of alternative columns to be used for tests in accordance with the United States Pharmacopeia and National Formulary (USP-NF) monographs. The working group is starting with the L1 category due to the large number of columns within this classification and plans to extend its work to other column categories in the future.

"The group was created to help users of USP monographs simplify their column selections," said Margareth Marques, USP scientist and working group coordinator. "More than 220 HPLC columns can be classified as L1 for use with USP monographs, and this makes it difficult for an analyst to chose the proper column to use. USP wants to help column users streamline their processes and find alternative column choices."

The working group has decided to use NIST Standard Reference Material 870 to create the subclassifications. They will examine four characteristics (hydrophobicity, chelating, silanol activity, and shape selectivity) for each column, and the results from this study will be used to develop the subclassification criteria.

By this fall, the working group plans to have the necessary data to subclassify the L1 (C18) columns. For further information about the working group, please contact Margareth Marques, scientist at USP, at 301-816-8106 or e-mail her at mrm@usp.org.

USP Seeks Public Comment for Sixteen Proposed Dietary Supplement Monographs

In its May­June Pharmacopeial Forum (PF), the United States Pharmacopeia (USP) is seeking final public comment on 16 dietary supplement monographs that will appear in the United States Pharmacopeia and National Formulary (USP­NF). The monographs appear in the In-Process Revision section of the PF. This is the final opportunity to provide comments before the monographs are finalized in the USP­NF.

The PF is USP's journal of standards development and the primary vehicle for the public to provide input or comments on USP standards. For the following monographs USP is seeking public comment on:
· Horse Chestnut
· Powdered Horse Chestnut
· Powdered Horse Chestnut Extract
· Red Clover
· Powdered Red Clover
· Powdered Red Clover Extract
· Red Clover Tablets
· Ginger Capsules
· Powdered Kava Extract
· Semisolid Kava Extract
· Kava Capsules
· Kava Tablets
· a-Lipoic Acid Capsules
· a-Lipoic Acid Tablets
· Saw Palmetto Extract
· Sesame Oil (as an excipient)
Comments on the proposed dietary supplement monographs should be addressed and mailed by Oct. 1, 2002 to Dr. Gabriel Giancaspro at USP, 12601 Twinbrook Parkway, Rockville, MD 20852. Additional questions concerning dietary supplement monographs can be sent to mediarealtions@usp.org.

USP-The Standard of Quality

USP is a non-government organization that promotes the public health by establishing state-of-the-art standards to ensure the quality of medicines and other health care technologies. These standards are developed by a unique process of public involvement and are recognized worldwide. In addition, USP has public health programs that focus on promoting optimal health care, including the Dietary Supplement Verification Program (DSVP), Health Care Information, and Patient Safety. USP is a not-for-profit organization that achieves its goals through the contributions of volunteers representing pharmacy, medicine, and other health care professions, as well as science, academia, government, the pharmaceutical industry, and consumer organizations. For more information, visit www.usp.org/e-newsroom.