AMPOULE CONTENTS:   Each ampoule contains the residue after freeze-drying of 0.5 ml of a solution that contained: 1.17 microgram IL-1a 3 mg trehalose; 0.5 mg human serum albumin; 50 mM sodium phosphate buffer

UNITAGE:   The assigned potency is 117,000 international units (IU) per ampoule.

CAUTION:   The preparation contains material of human origin (human serum albumin) which has been tested and found negative for HBsAg and anti-HIV (LAV/HTLV III virus) antibody. However, as with all preparations of human origin, this material cannot be assumed to be free from infectious agents. Suitable precautions should be taken in the use and disposal of the ampoule and its contents. This preparation is not for administration to humans.

USE OF AMPOULED MATERIAL:   For calibration of national standards/reference preparations, local, i.e. 'in house' standards and commercially available materials. For all practical purposes, each ampoule contains the same quantity of the substances listed above. Dissolve the total contents of the ampoule in a known volume of suitable solvent (distilled water, saline or buffer) with carrier protein where extensive dilution is required. No attempt should be made to weigh out any portion of the freeze-dried material.

STORAGE:   Unopened ampoules should be stored at -20oC. For economy of use, it is recommended that the solution be sub-divided into several small containers and stored at -40oC or below. The ampoules do not contain bacteriostat and solutions of the ampouled preparation should not be assumed to be sterile.

CITATION:   The evaluation of this international standard is described in the following paper: S. POOLE & R.E. GAINES DAS. The International Standards for Interleukin-1Alpha and Interleukin-1Beta: Evaluation in an International Collaborative Study. J. Immunol. Methods. 142, 1-13. (1991). In all publications in which the 1st International Standard for Interleukin-1 alpha (code 86/632) is used as an assay calibrant, it is important that the title of the preparation and ampoule code be cited correctly.

SOURCE:   The IL-1 contained in this ampoule was selected from three preparations generously contributed by the Immunex Corporation, Dainippon Pharmaceutical Co. and Biogen SA to the National Institute for Biological Standards and Control (NIBSC), which is a WHO International Laboratory for Biological Standards.

This reagent is available in small amounts (approximately 1 microgram/sample) for use in the calibration of in vitro bioassays and in-house standards only and are not to be used for experimental purposes. Reference reagents are available to investigators with peer-reviewed support, at institutions or at commercial establishments and are limited to one sample of each reagent per year.