Glycoprotein Hormone Reference Preparations

Glycoprotein hormones (FSH, LH, TSH) have been assigned potencies based upon in vivo biological assays because pure preparations have not been available and, due to carbohydrate moieties, considerable microheterogeneity is present in each of these hormones. To standardize glycoprotein hormone assay systems, the World Health Organization distributes reference preparations for each of the pituitary glycoprotein hormones. Historically, these have been highly purified, but not chemically pure, preparations with assigned potencies based on biological assays relative to arbitrarily selected preparations available at the time the reference materials were established. Since the establishment of these reference preparations, it has been necessary to replace them with additional materials, often more highly purified than the original reference, and to evaluate potencies based upon in vitro (e.g., RIA) as well as in vivo (e.g., bioassays) assay systems. In some cases, potencies vary as a function of the particular reference preparation used, and, in general, RIA's are more heterogeneous than in vivo bioassays.

Definitions:

hMG or human Menopausal Gonadotropin

a gonadotropin prepared from urine of menopausal and post-menopausal women.

IU or International Unit

the specified biological (in vivo) activity contained in a defined weight of the current International Standard.

IS or International Standard

a preparation to which an IU is assigned on the basis of an international collaborative study.

IRP or International Reference Preparation

similar to an IS, but established when a collaborative study indicates the preparation is not entirely suitable as an International Standard, or established before a complete collaborative study has been conducted.

References:

1. National Institute for Biological Standards and Control, Descriptions of each Reference Preparation.
2. Rosenberg, E., in: Gonadotropins, 1968, Geron-X, Inc., Los Altos, CA USA