Upcoming USP preview monographs will include garlic, ginkgo, ginseng, feverfew.

USP PREVIEW MONOGRAPHS FOR GARLIC, GINKGO, GINSENG AND FEVERFEW will be published for comment in the Pharmacopeial Forum over the next five months, according to the U.S. Pharmacopoeia. Preview monographs for garlic and ginkgo are planned for publication in the March/April issue, as is a revised version of the ginger monograph. A preview monograph for ginger appeared in the May/June 1996 Forum.

The January/February Pharmacopeial Forum contains preview monographs for valerian and powdered valerian. Preview monographs for ginseng and feverfew will appear in this year's May/June issue and monographs for a number of other commonly used botanicals also are under development, USP said.

Compiled by the USP Subcommittee on Natural Products, the valerian and powdered valerian monographs are "based on surveys of the literature conducted on the various online databases on natural products, such as Medline, Napralert and Chemical Abstracts" and on input from members of an advisory panel.

The valerian monograph specifies that "valerian consists of the subterranean parts of Valeriana officinalis Linne (Fam. Valerianaceae) including the rhizome, roots and stolons" and "contains not less than .5% of volatile oil and not less than .05% of valerenic acid, calculated on the dried basis." Powdered valerian is defined as "valerian reduced to a fine or a very fine powder" that "contains no calcium oxalate crystals and no foreign starch granules."

Valerian should be stored "in tight containers, protected from light and moisture," the monograph states. Powdered valerian should be preserved "in well-closed containers, protected from light and moisture." Labeling should identify the product as valerian or powdered valerian and list "the genus and species of the botanical source from which it was derived."

The monographs contain descriptions of valerian's macroscopic botanic characteristics and histology. Lab tests for identification, extractable matter and content of valerenic acid are detailed in the valerian monograph, as are upper limits for total ash, acid-insoluble ash, water content, foreign organic matter and total bacterial count.

Speaking at a Jan. 29 Drug Information Association workshop on botanical testing in Washington, D.C., USP Division of Drug Standards Senior Scientist Srini Srinivasen, PhD, stressed the difficulty of developing reference standards for botanical products. However, he noted that reference standards similar to those for synthetic drugs sometimes can be developed for botanicals based on their "active ingredients." Ginger can be defined by its capsaicin levels, for example, and valerian by its levels of valerenic acid, he explained.

Along with the reference monographs, informational monographs for the botanicals are under construction at USP. Informational monographs contain guidelines on proper use, precautions and potential side effects. The monographs for ginger and valerian are nearing completion, USP said, but no decision has been made regarding when and where they will appear for public comment.

In addition to the botanical monographs, published for comment in the January/February Pharmacopeial Forum are preview monographs for "Type 2" multisymptom cold capsules, tablets and oral solutions developed by the Subcommittee on Nonprescription Drugs and Nutritional Supplements "after a survey of the currently marketed nonprescription drugs in the category of cough, cold and allergy preparations." The subcommittee "is in the process of grouping these [OTCs] into defined classes with a view to developing and establishing family monographs."

Type 2 multisymptom cold products "contain phenylpropanolamine hydrochloride, and any two or all three of the following: acetaminophen, chlorpheniramine maleate and dextromethorphan hydrobromide." The proposed monographs specify packaging and storage requirements and USP reference standards. The monographs detail lab tests for identification and dissolution as well as assays for phenylpropanolamine hydrochloride, acetaminophen and chlorpheniramine maleate.

The Type 1 monograph, for multisymptom cold oral powder, appears in the July/August Forum. Type 1 oral powder "contains pseudoephedrine hydrochloride or pseudoephedrine sulfate, and any two or all three of the following: acetaminophen, chlorpheniramine maleate and dextromethorphan hydrobromide.