Malic Acid BP USP

Malic Acid BP Grade Eur Grade Specifications

C4H6O5 --- 134.1 --- CAS 6915-15-7Action and use: Excipient.

DEFINITION(2RS)-2-Hydroxybutanedioic acid.Content: 99.0 per cent to 101.0 per cent (anhydrous substance).

CHARACTERSAppearance: White or almost white, crystaler.Solubility: Freely soluble in water and in alcohol, sparingly soluble in acetone.

IDENTIFICATIONA. Melting point: 128°C to 132°C.B. Infrared absorption spectrotometry.

TESTSSolution S: Dissolve 5.00 g in water R and dilute to 25 ml with the same solvent.Appearance of solution: Solution S is clear and colourless.Optical rotation: - 0.10° to + 0.10°, determined on solution S.Water-insoluble substances: Maximum 0.1 per cent.Related substancesLiquid chromatogra (2.2.29).Limits: (Please see the original monograimpurity A: not more than twice the area of the corresponding peak in the chromatogram obtained with reference solution (b) (1.0 per cent);impurity B: not more than 0.25 times the area of the corresponding peak in the chromatogram obtained with reference solution (b) (0.05 per cent);any other impurity: for each impurity, not more than 0.5 times the area of the peak due to impurity B in the chromatogram obtained with reference solution (b) (0.1 per cent);total of other impurities: not more than 2.5 times the area of the peak due to impurity B in the chromatogram obtained with reference solution (b) (0.5 per cent);disregard limit: 0.1 times the area of the peak due to impurity B in the chromatogram obtained with reference solution (b) (0.02 per cent