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At least 1,153 records · Page 64Linked to original sources
PubMed1990

[Cyanocobalamin Reference Standard (Control 891) of National Institute of Hygienic Sciences].

Cyanocobalamin was tested for preparation on the "Cyanocobalamin Reference Standard (Control 891)". Analytical data obtained were as follows: loss on drying, 9.77%; infrared spectrum, same as that of the Cyanocobalamin Reference Standard (Control 871); thin-layer chromatography, five contaminants were detected; high-performance liquid chromatography, nine contaminants were detected; assay, 100.00% by JP XI method and 99.79% by HPLC method in terms of the JP Reference Standard (Control 871), respectively. On the basis of the above results, this material was authorized as the Japanese Pharmacopoeia Standard (Control 891).

Chromatography, High Pressure Liquid↗
PubMed1991

[Cholecalciferol Reference Standard (Control 901) of the National Institute of Hygienic Sciences].

Cholecalciferol Reference Standard for the Japanese Pharmacopoeia (JP RS) was prepared. The following analytical data were obtained: melting point 85.8 degrees C; UV and IR spectra were in agreement with both of the previous JP RS and USP RS of Cholecalciferol; absorptivity at 265 nm E1%lcm = 476; optical rotation [alpha]20D = + 110.1 degrees; no impurities were detected by TLC and HPLC analyses; assay 100.1% by HPLC against the USP RS. Based on the above results, the raw material was authorized as the Reference Standard of the National Institute of Hygienic Sciences.

Cholecalciferol↗
PubMed1991

[Ergocalciferol Reference Standard (Control 901) of the National Institute of Hygienic Sciences].

Ergocalciferol Reference Standard for the Japanese Pharmacopoeia (JP RS) was prepared. The following analytical data were obtained: melting point 118.4 degrees C; UV and IR spectra were in agreement with both of the previous JP RS and USP RS of ergocalciferol; absorptivity at 265nm E1%lcm = 467; optical rotation [alpha]20D = 103 degrees; no impurities were detected by TLC and HPLC analyses; assay 100.1% by HPLC against the USP RS. Based on the above results, the raw material was authorized as the Reference Standard of the National Institute of Hygienic Sciences.

Chromatography, High Pressure Liquid↗
PubMed1991

[Prednisolone Acetate Reference Standard (Control 901) of the National Institute of Hygienic Sciences].

Prednisolone Acetate Reference Standard (Control 901) for the Japanese Pharmacopoeia (JP RS) was prepared. The following analytical data were obtained: melting point 236 degrees C (decomposition); IR spectrum was same as that of JP RS of prednisolone acetate; absorptivity at 243 nm E1%lcm = 379; optical rotation [alpha]20D = +113.0 degrees; no impurity was detected by TLC, but a small amount of two impurities was found by HPLC analysis; assay by HPLC against the JP RS 100.2%. Based on the above results, this raw material was authorized as the Reference Standard of the National Institute of Hygienic Sciences.

Chromatography, High Pressure Liquid↗
PubMed1991

[Fluocinolone Acetonide Reference Standard (Control 901) of the National Institute of Hygienic Sciences)].

Fluocinolone Acetonide Reference Standard (Control 901) for the Japanese Pharmacopoeia (JP RS) was prepared. The following analytical data were obtained: melting point 268 degrees C (decomposition); IR spectrum was same as the previous JP RS of Fluocinolone Acetonide; absorptivity at 237nm E1%1lcm = 363; optical rotation [alpha]20D = 105.7 degrees; no impurity was detected by TLC, but two impurities were detected by HPLC analysis; assay by HPLC against the previous JP RS 100.2%. Based on the above results, this raw material was authorized as the Reference Standard of the National Institute of Hygienic Sciences.

Chromatography, High Pressure Liquid↗
PubMed1991

[Methoxalene Reference Standard (Control 901) of National Institute of Hygienic Sciences].

The raw material of methoxalene was examined for the preparation of the "Methoxalene Reference Standard". Analytical data obtained were as follows: ultraviolet spectrum, lambda max = 300, 249 and 218 nm; absorbance, E1cm(1%) (300 nm) = 559; infrared spectrum, same as that of USP Reference Standard of Methoxalene; melting point, 148 degrees C; thin-layer chromatography, no impurities were detected until 50 micrograms; high-performance liquid chromatography (HPLC), no impurities were detected, water, 0.04%; assay, 99.9% by absorbance method and 100.4% by the HPLC method in terms of the USP Reference Standard. Based on the above results, this raw material was authorized to be the Reference Standard of the National Institute of Hygienic Sciences.

Chromatography, High Pressure Liquid↗
PubMed1991

[Indocyanine Green Reference Standard (Control 901) of National Institute of Hygienic Sciences].

The raw material of indocyanine green was examined for the preparation of the "Indocyanine green Reference Standard (Control 901)". Analytical data obtained were as follows: ultraviolet and visible spectrum, lambda max = 785, 394, 216 nm; absorbance, E1cm(1%) (785 nm) = 3239; infrared spectrum, same as Indocyanine Green USP Reference Standard; sodium iodide, 4.1%; thin-layer chromatography, no impurities were detected until 100 micrograms; high-performance liquid chromatography, 4 impurities were detected; loss on drying, 1.8%; assay, 103.4% against USP Reference Standard. Based on the above results, this raw material was authorized to be the Reference Standard of the National Institute of Hygienic Sciences.

Chromatography, High Pressure Liquid↗
PubMed1991

[Tolnaftate Reference Standard (Control 901) of National Institute of Hygienic Sciences].

The raw material of tolnaftate was examined for the preparation of the "Tolnaftate Reference Standard". Analytical data obtained were as follows: ultraviolet spectrum, lambda max = 257 nm; absorbance, E1cm1% (257 nm) = 723; infrared spectrum, same as that of USP Reference Standard of Tolnaftate; melting point, 112.1 degrees C; thin-layer chromatography, no impurities were detected until 500 micrograms; high-performance liquid chromatography, no impurities were detected; loss on drying, 0%; water, 0.01%; assay, 100.4% by absorbance method and 100.1% by the HPLC method in terms of the USP Reference Standard. Based on the above results, this raw material was authorized to be the Reference Standard of the National Institute of Hygienic Sciences.

Chromatography, High Pressure Liquid↗
PubMed1991

[Retinol Acetate Reference Standard for Thin-layer Chromatography (Control 901) and Retinol Palmitate Reference Standard for Thin-layer Chromatography (Control 901) of National Institute of Hygienic Sciences].

The raw materials of retinol acetate and retinol palmitate were examined for the preparation of the "Retinol Acetate Reference Standard for Thin-layer Chromatography" and "Retinol Palmitate Reference Standard for Thin-layer Chromatography", respectively. Analytical data obtained were as follows: thin-layer chromatography, no impurities were detected in retinol acetate and one impurities was detected in retinol palmitate; The Rf values of retinol acetate and retinol palmitate were consistent with those of Reference Standards (Control 713), respectively; ultraviolet spectrum, lambda max = 326 approximately 327 nm; relative extinction, within the range reported in JPXI; weight variation of capsules, retinol acetate 224.0 +/- 15.5 mg (RSD 6.9%), retinol palmitate 222.0 +/- 13.8 mg (RSD 6.2%); assay, retinol acetate 57000 I.U./g, retinol palmitate 57000 I.U./g. Based on the above results, these raw materials were authorized to be the Reference Standards of the National Institute of Hygienic Sciences.

Chromatography, Thin Layer↗
PubMed1991

[Methylergometrine Maleate Reference Standard (Control 891) of National Institute of Hygienic Sciences].

The raw material of methylergometrine maleate was examined for the preparation of the "Methylergometrine Maleate Reference Standard". Analytical data obtained were as follows: melting point, 181.7 degrees C; ultraviolet spectrum, lambda max = 313 nm; absorbance, E1%1cm (313 nm) = 181.3; infrared spectrum, 3406, 2962, 2928, 1645, 1574 cm-1; thin-layer chromatography, 6 impurities were detected; high-performance liquid chromatography, no impurities were detected; loss on drying, 0.02%; optical rotation, [alpha]20D = + 44.04 degrees; assay, 99.5% against Ergometrine Maleate Reference Standard (Control 755). Based on the above results, this raw material was authorized to be the Reference Standard of the National Institute of Hygienic Sciences.

Chromatography, High Pressure Liquid↗
PubMed1991

[Cyclandelate Reference Standard (Control 901) of National Institute of Hygienic Sciences].

The raw material of cyclandelate was examined for preparation of the "Cyclandelate Reference Standard". Analytical data obtained were as follows: melting point, 60 degrees C; ultraviolet spectrum, lambda max = 252, 258 and 264 nm E1%1cm = 6.1 (252 nm), 7.5 (258 nm), 5.9 (264 nm); infrared spectrum, 3454, 2948, 1730, 1453, 1202, 737, 695 cm-1; thin-layer chromatography, no impurities were detected until 1000 micrograms; high-performance liquid chromatography (HPLC), one impurity was detected, loss on drying, 0.00%. Based on the above results, this raw material was authorized to be the Reference Standard of the National Institute of Hygienic Sciences.

Chromatography, High Pressure Liquid↗
PubMed1991

[Potassium Sucrose Octa Sulfate Reference Standard (Control 901) of National Institute of Hygienic Sciences].

The raw material of potassium sucrose octa sulfate was examined for the preparation of the "Potassium sucrose octa sulfate Reference Standard (Control 901)". Analytical data obtained were as follows: infrared spectrum, 3494, 1642, 1247, 1002, 795, 584 cm-1; high-performance liquid chromatography, 3 impurities were detected; water, 6.2%; assay of sucrose octa sulfate, 99.1%. Based on the above results, this raw material was authorized to be the Reference Standard of the National Institute of Hygienic Sciences.

Chromatography, High Pressure Liquid↗
PubMed1991

[Riboflavin Reference Standard (Control 891) of National Institute of Hygienic Sciences].

The raw material of riboflavin was examined for the preparation of the "Riboflavin Reference Standard (Control 891)". Analytical data obtained were as follows: melting point, 238.2 degrees C (decomposition); absorbance, E1%1cm = 859 (267 nm), 277 (372 nm), 327 (445 nm); infrared spectrum, same as Riboflavin Reference Standard (Control 872); thin-layer chromatography, 5 impurities were detected; high-performance liquid chromatography, 11 impurities were detected; loss on drying, 0.25%; optical rotation, [alpha]20D = -133.6 degrees; solubility, less than 16 min; assay, 100.1% against Riboflavin Reference Standard (Control 872). Based on the above results, this raw material was authorized to be the Reference Standard of the National Institute of Hygienic Sciences.

Chromatography, High Pressure Liquid↗
PubMed1991

[d-Camphor Reference Standard (Control 901) and dl-Camphor Reference Standard (Control 901) of National Institute of Hygienic Sciences].

The raw materials of d-camphor and dl-camphor were examined for the preparation of the "d-Camphor Reference Standard" and "dl-Camphor Reference Standard". Analytical data obtained were as follows: ultraviolet spectrum, lambda max = 257 nm; absorbance, E1%1cm(257 nm) = 723; infrared spectrum, 2956, 1742, 1045 cm-1; optical rotation, [alpha]20D = +42.9 degrees (d-camphor), [alpha]20D = -0.00 degrees (dl-camphor); melting point, 180 degrees C (d-camphor), 179 degrees C (dl-camphor); gas-chromatography, one impurity was detected in d-camphor and four impurities were detected in dl-camphor. Based on the above results, these raw materials were authorized to be the Reference Standards of the National Institute of Hygienic Sciences.

Camphor↗
PubMed1992

[Pyridoxine hydrochloride reference standard (Control 911) of the National Institute of Hygienic Sciences].

The raw material of pyridoxine hydrochloride was examined for preparation of the "Pyridoxine Hydrochloride Reference Standard". Analytical data obtained were as follows: loss on drying, 0.00%; pH, 2.87; melting point, 204.6 degrees C (decomposition); infrared spectrum, same as Pyridoxine Hydrochloride Reference Standard (Control 879); thin-layer chromatography, nonimpurities were detected; assay, 100.0% by non-aqueous titration and 100.0% by UV spectrophotometry. Based on the above results, the raw material was authorized as the Japanese Pharmacopoeia Standard (Control 911).

Chromatography, Thin Layer↗
PubMed1992

[Tocopherol reference standard (Control 911) of the National Institute of Hygienic Sciences].

The raw material for tocopherol was tested for preparation of the "Tocopherol Reference Standard (Control 911)". Analytical data obtained were as follows: infrared spectrum, same as Tocopherol Reference Standard (Control 881); absorptivity, E1%1cm (292nm) = 75.5; thin-layer chromatography, no impurities were detected up to 50.0 micrograms; high performance liquid chromatography (HPLC), four impurities were detected; assay, 100.7% by HPLC. Based on the above results, the raw material was authorized as the Japanese Pharmacopoeia Standard (Control 911).

Chromatography, High Pressure Liquid↗
PubMed1992

[Prednisolone reference standard (Control 911) of the National Institute of Hygienic Sciences].

Prednisolone was tested for preparation of the "Prednisolone Reference Standard (Control 911)". The quality of raw material was examined and compared with the previous Reference Standard (Control 872). Analytical data obtained were as follows: loss on drying, 0.10%; melting point, 233.2 degrees C (decomposition); optical rotation, [alpha]20D+98.77 degrees; UV spectrum, lambda max = 243nm; absorptivity, E1%1cm (243nm) = 413.5; IR spectrum, 1711, 1612, 1110, 888cm-1; one impurity was detected by thin-layer chromatography and high-performance liquid chromatography (HPLC), respectively; assay, 100.1% by HPLC. Based on the above results, the raw material was authorized as the Japanese Pharmacopoeia Standard (Control 911).

Chromatography, Thin Layer↗
PubMed1992

[d-Camphor reference standard (Control 911) and dl-Camphor Reference Standard (Control 911) of the National Institute of Hygienic Sciences].

The raw materials of d-camphor and dl-camphor were examined for preparation of the "d-Camphor Reference Standard" and "dl-Camphor Reference Standard". Analytical data obtained were as follows: ultraviolet spectrum, lambda max = 290nm; infrared spectrum, 2958, 1742, 1045cm-1; optical rotation, [alpha]D20 = +42.7 degrees (d-camphor), [alpha]D20 = -0.3 degrees (dl-camphor); melting point, 180 degrees C (d-camphor), 179 degrees C (dl-camphor); gas-chromatography (GC), one impurity was detected in d-camphor and three impurities in dl-camphor; assay, 99.5% (d-camphor), 99.5% (dl-camphor) by GC. Based on the above results, these raw materials were authorized as the Japanese Pharmacopoeia Standard (Control 911).

Camphor↗