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The raw material for prednisolone sodium phosphate was examined for the preparation of the "Prednisolone Sodium Phosphate Reference Standard (Control 001)". The analytical data obtained were: pH, 7.9; optical rotation, [alpha]D20 = +98.0 degrees; UV spectrum, lambda max of 248 nm and specific absorbance in ethanol at 248 nm = 306.7; IR spectrum, same as that of the Prednisolone Sodium Phosphate Reference Standard (Control 892); thin-layer chromatography, five impurities were detected at 200 micrograms; high-performance liquid chromatography (HPLC), total amount of impurities estimated to be less than 3.7%; residual solvent, 0.0% (ethanol) and 0.0% (hexane); loss on drying, 2.7%. Based on the above results, the raw material was authorized as the Prednisolone Sodium Phosphate Reference Standard (Control 001) of the National Institute of Health Sciences.
M Iwata, and
T Koide, and
K Maekawa, and
H Saito, and
T Tanimoto, and
S Okada
January 1990,
Eisei Shikenjo hokoku. Bulletin of National Institute of Hygienic Sciences,
M Iwata, and
T Koide, and
K Maekawa, and
H Saito, and
T Tanimoto, and
S Okada
January 1998,
Kokuritsu Iyakuhin Shokuhin Eisei Kenkyujo hokoku = Bulletin of National Institute of Health Sciences,
M Iwata, and
T Koide, and
K Maekawa, and
H Saito, and
T Tanimoto, and
S Okada
January 1995,
Eisei Shikenjo hokoku. Bulletin of National Institute of Hygienic Sciences,
M Iwata, and
T Koide, and
K Maekawa, and
H Saito, and
T Tanimoto, and
S Okada
January 1990,
Eisei Shikenjo hokoku. Bulletin of National Institute of Hygienic Sciences,
M Iwata, and
T Koide, and
K Maekawa, and
H Saito, and
T Tanimoto, and
S Okada
January 1990,
Eisei Shikenjo hokoku. Bulletin of National Institute of Hygienic Sciences,
M Iwata, and
T Koide, and
K Maekawa, and
H Saito, and
T Tanimoto, and
S Okada
January 1990,
Eisei Shikenjo hokoku. Bulletin of National Institute of Hygienic Sciences,
M Iwata, and
T Koide, and
K Maekawa, and
H Saito, and
T Tanimoto, and
S Okada
January 2000,
Kokuritsu Iyakuhin Shokuhin Eisei Kenkyujo hokoku = Bulletin of National Institute of Health Sciences,
M Iwata, and
T Koide, and
K Maekawa, and
H Saito, and
T Tanimoto, and
S Okada
January 1989,
Eisei Shikenjo hokoku. Bulletin of National Institute of Hygienic Sciences,
M Iwata, and
T Koide, and
K Maekawa, and
H Saito, and
T Tanimoto, and
S Okada
January 1992,
Eisei Shikenjo hokoku. Bulletin of National Institute of Hygienic Sciences,
M Iwata, and
T Koide, and
K Maekawa, and
H Saito, and
T Tanimoto, and
S Okada
January 1991,
Eisei Shikenjo hokoku. Bulletin of National Institute of Hygienic Sciences,
