[Alprostadil Reference Standard (Control 001) of National Institute of Health Sciences]

The raw material of Alprostadil was examined for the preparation of "Alprostadil Reference Standard (Control 001)". Analytical data obtained were: IR spectrum, same as that of the Alprostadil Reference Standard (Control 923); thin-layer chromatography, no impurities were detected until 20 micrograms; high-performance liquid chromatography (HPLC), total amount of impurities estimated to be less than 0.2%. Based on the above results, the raw material was authorized as the Japanese Pharmacopoeia Alprostadil Reference Standard (Control 001).