地诺前列素氨丁三醇

Appearance

White or off- white powder

off- white powder

Identification(IR)

The IR spectrum of the sample exhibits maximun only at the same wavelength as that similar preparation of USP Dinoprost Tromethamine RS

Conforms

Solubility

Very soluble in water,freely soluble in ethanol(96%),practically insoluble in acetonitrile

Conforms

Optical  rotation

+19°~ +26°

+23.4°

Loss on drying

N.M.T 1.0%

0.17%

Residue on ignition

N.M.T 0.5%

0.08%

Water

N.M.T 1.0%

0.20%

Residual solvents

Ethyl acetate: N.M.T. 5000ppm

N.D

Acetone: N.M.T. 5000ppm

1033ppm

Acetontrile: N.M.T. 410ppm

N.D

Ethanol: N.M.T. 5000ppm

N.D

Methanol: N.M.T. 3000ppm

N.D

Terahydrofuran : N.M.T. 720ppm

N.D

Chromatographic Purity

Impurity A: N.M.T. 2.0%

1.2%

Impurity B: N.M.T. 1.5%

N.D

Any unspecified impurity: N.M.T. 0.10%

0.17%

Total other impurities: N.M.T. 2.0%

0.40%

Assay

95.0~105.0%( calculated on the dried basis)

97.6%