RESUMO
The raw material of fluorometholone was examined for the preparation of the "Fluorometholone Reference Standard (Control 011)". The analytical data obtained were: optical rotation, [alpha]20D = .5 degrees; UV spectrum, lambda max of 240 nm and specific absorbance in methanol at 240 nm = 350.7; IR spectrum, same as that of the Fluorometholone Reference Standard (Control 864); high-performance liquid chromatography (HPLC), total amount of impurities estimated to be less than 0.5%; loss on drying, 0.01%. Based on the above results, the raw material was authorized as the Fluorometholone Reference Standard (Control 011) of the National Institute of Health Sciences.
Assuntos
Fluormetolona/normas , Fenômenos Químicos , Físico-Química , Cromatografia Líquida de Alta Pressão , Fluormetolona/análise , Órgãos Governamentais , Japão , Padrões de ReferênciaRESUMO
The raw material of tocopherol succinate was tested for the preparation of the "Tocopherol Succinate Reference Standard (Control 021)". Analytical data obtained were as follows: infrared spectrum, same as that of the Tocopherol Succinate Reference Standard (Control 981); specific absorbance, E1% 1 cm (286 nm) = 40.7; thin-layer chromatography, no impurities were detected until 50.0 micrograms; high-performance liquid chromatography (HPLC), four impurities were detected and the amount of tocopherol succinate was estimated to be 99.0%; loss on drying, 0.11%. Based on the above results, the raw material was authorized as the Japanese Pharmacopoeia Reference Standard (Control 021).
Assuntos
Farmacopeias como Assunto/normas , Vitamina E/análogos & derivados , Vitamina E/normas , Cromatografia Líquida de Alta Pressão , Órgãos Governamentais , Japão , Padrões de Referência , Tocoferóis , Vitamina E/análiseRESUMO
The raw material of glycyrrhizinic acid was examined for preparation of the "Glycyrrhizinic Acid Reference Standard". The analytical data obtained were: UV spectrum: lambda max, 251 nm; and specific absorbance (E1% 1 cm) in ethanol at 251 nm, 149.6 (Control 0211) and 145.7 (Control 0221); IR spectrum, specific absorptions of raw material were consistent with that of Standard (Control 001). Also, thin-layer chromatography, no impurity was detected; high-performance liquid chromatography, several impurities were detected. The amount of each impurity was estimated at less than 0.2% and total amount of impurities was less than 0.6%. Based on the above results, the candidate materials were authorized as the Glycyrrhizinic Acid Reference Standard (Control 0211 and 0221) of the National Institute of Health Sciences.
Assuntos
Ácido Glicirrízico/normas , Cromatografia Líquida de Alta Pressão , Ácido Glicirrízico/análise , Órgãos Governamentais , Japão , Farmacopeias como Assunto/normas , Padrões de ReferênciaRESUMO
The raw material of paeoniflorin was examined for preparation of the "Paeoniflorin Reference Standard". The analytical data obtained were: UV spectrum: lambda max, 231.7 nm; and specific absorbance (E1% 1 cm) in methanol at 230 nm, 265.4; IR spectrum, specific absorptions of raw material were consistent with that of Standard (Control 985). High-performance liquid chromatography, several impurities were detected. The amount of each impurity was estimated at less than 0.1% and total amount of impurities was less than 0.2%. Based on the above results, the candidate material was authorized as the Paeoniflorin Reference Standard (Control 011) of the National Institute of Health Sciences.
