Abstract

Microbiological assays are used to measure drug potency but unwanted degradation products or impurities may positively interfere. A case in point is the tetra-cycline salts with normal moisture content in the cylinder-plate assay against Bacillus subtilis. Thermal degradation doubles the potency of tetracycline in this microbiological assay. Ultraviolet and infrared spectrophotometry indicate that aromatization and decarboxamidation are implicated. The resultant products have greater diffusivity and sufficient potency in the agar of the cylinder-plate assay method so that an apparently greater drug assay results. Dry tetracycline salts are thermally stable. Normal moisture content does not induce instability at usual storage temperatures. The kinetics of acid degradation of tetracycline phosphate and hydrochloride are the same.

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