Malic Acid BP USP

Malic Acid BP Grade Ph Eur Grade Specifications C4H6O5 --- 134.1 --- CAS 6915-15-7 Action and use: Excipient. DEFINITION (2RS)-2-Hydroxybutanedioic acid. Content: 99.0 per cent to 101.0 per cent (anhydrous substance). CHARACTERS Appearance: White or almost white, crystalline powder. Solubility: Freely soluble in water and in alcohol, sparingly soluble in acetone. IDENTIFICATION A. Melting point: 128°C to 132°C. B. Infrared absorption spectrophotometry. TESTS Solution 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 substances Liquid chromatography (2.2.29). Limits: (Please see the original monograph) impurity 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