INTERIM REFERENCE PREPARATION OF GRANULOCYTE COLONY STIMULATING FACTOR (recDNA HUMAN)

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AMPOULE CONTENTS
Each ampoule contains the residue after freeze-drying of 0.5 ml of a 0.15 M solution of sodium chloride that contained: approximately 100 ng G-CSF; 0.5 trehalose; 1.0 human serum albumin.

UNITAGE
The assigned potency is 10,000 arbitrary units 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 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 a suitable solvent (distilled water, saline or buffer) with carrier protein where extensive dilution is required. No attempts should be made to weigh out any portion of the freeze-dried material.

STORAGE
Unopened ampoules should be stored at -20oC. The ampoules do not contain bacteriostat.

CITATION
In all publications in which this preparation is used as an assay calibrant, it is important that the title of the preparation and ampoule code be cited correctly.

This reagent is available in small amounts (approximately 0.1 microgram/sample) for use in the calibration of in vitro bioassays and in-house standards only and is 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.