Practically insoluble in water and in alcohol (96%). It dissolves in dilute solutions of alkali hydroxides
Solubility (JP)
Practically insoluble in water and in ethanol (99.5%). It dissolves in 1 mol/L hydrochloric acid TS.
Identification 1 : FTIR (JP)
Both spectra exhibit similar intensities of absorption at the same wave numbers
Identification A : FTIR (USP)
Matches with the standard pattern
Identification A : Specific rotation (EP, BP)
-224.00 to -218.00° (c= 2% in 1M HCl acid at 20 ± 0.5°C, dried substance)
Identification B : Specific rotation (USP)
-225.00° to -215.00° (c= 2% in 1N hydrochloric acid at 20°C, perform the measurements immediately after preparation)
Identification B : FTIR (EP, BP)
Matches with the standard pattern
Identification C : TLC (USP)
The Rf value of the principal spot of the sample solution in the test for organic impurities corresponds to that of the standard solution
Identification C : TLC (BP, EP)
The principal spot in the chromatogram obtained with test solution (b) is similar in position, colour and size to the principal spot in the chromatogram obtained with reference solution (a).
Identification D : (EP, BP)
Turbidity or a white precipitate develops within 3 min
Appearance of solution (EP, BP)
10% solution in dilute hydrochloric acid R is clear and not more intensely coloured than reference solution Y7
Clarity and color of solution : (JP)
10% solution in 2M hydrochloric acid TS is clear and colorless
Specific rotation (EP, BP)
-224.00 to -218.00° (c = 2% in 1M HCl acid at 20 ± 0.5°C, dried substances)
Specific rotation (USP)
-225.00° to -215.00° (c = 2% in 1N hydrochloric acid at 20°C)
Specific rotation (JP)
-225.00° to -215.00° (c = 2% in 1M hydrochloric acid at 20°C, after drying)