エルカトニン注射製剤の先発および後発医薬品における品質試験

抄録

Elcatonin injection is used for the treatment of osteoporosis in Japan.In order to compare the original product with generic versions, we measured the elcatonin content and amounts of impurities in both using high performance liquid chromatography, and observed changes in content with time under the conditions of light exposure and shaking.
We found that elcatonin content and amounts of impurities varied among the generics and that changes in content with time under the above conditions for some generics were greater than the changes for the original product.These results suggest that some generic products should not be considered to be equivalent to the original product.