Malic Acid BP USP FCC Food Grade & Maleic Acid BP USP Grade Manufacturers
MSDS of Malic Acid
MSDS of Maleic Acid
Malic Acid and Maleic Acid are two different chemical compounds, often confused.
Malic Acid BP Grade Ph Eur
C4H6O5 --- 134.1 --- CAS Number 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.
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).
Heavy metals: Maximum 20 ppm.
Water: Maximum 2.0 per cent, determined on 1.00 g.
Sulphated ash: Maximum 0.1 per cent, determined on 1.0 g.
ASSAY
Dissolve 0.500 g in 50 ml of carbon dioxide-free water R. Titrate with 1 M sodium hydroxide determining the end-point potentiometrically. 1 ml of 1 M sodium hydroxide is equivalent to 67.05 mg of C4H6O5.
IMPURITIES
Specified impurities A, B. (Please see the original monograph)
R' --- COOH --- R
A. R = CO2H, R' = H: (E)-butenedioic acid (fumaric acid),
B. R = H, R' = CO2H: (Z)-butenedioic acid (maleic acid).
Malic Acid USP Grade
C4H6O5 134.09
Hydroxybutanedioic acid, (±)-.
(±)-Malic acid.
(±)-Hydroxysuccinic acid CAS Number 617-48-1
Malic Acid contains not less than 99.0 percent and not more than 100.5 percent of C4H6O5.
Identification: Infrared Absorption 197K , on undried specimen.
Residue on ignition: not more than 0.1%.
Water-insoluble substances: Dissolve 25 g in 100 mL of water, filter the solution through a tared filtering crucible, wash the filter with hot water, and dry at 100 to constant weight: the increase in weight is not more than 25 mg (0.1%).
Heavy metals: 0.002%.
Fumaric and maleic acids: To pass the test. Not more than 1.0% of fumaric acid and not more than 0.05% of maleic acid are found.
Organic volatile impurities: meets the requirements.
Assay: Transfer about 2 g of Malic Acid, accurately weighed, to a conical flask, dissolve in 40 mL of recently boiled and cooled water, add phenolphthalein TS, and titrate with 1 N sodium hydroxide VS to the first appearance of a faint pink color that persists for not less than 30 seconds. Each mL of 1 N sodium hydroxide is equivalent to 67.04 mg of C4H6O5.
Malic Acid FCC Food Grade
DL-Malic Acid; Hydroxysuccinic Acid;
2-Hydroxybutanedioic Acid
C4H6O5 Formula wt 134.09
INS: 296 CAS Number 617-48-1
DESCRIPTION
Malic Acid occurs as a white or nearly white, crystalline powder or granules having a strongly acid taste. One gram dissolves in 0.8 mL of water and in 1.4 mL of alcohol. Its solutions are optically inactive. It melts at about 130°C.
Function: Acidifier; flavoring agent.
REQUIREMENTS
Identification: The infrared absorption spectrum of a neat dispersion of the sample between two potassium bromide plates exhibits maxima only at the same wavelengths as those of a similar preparation of USP Malic Acid Reference Standard.
Assay: Not less than 99.0% and not more than 100.5% of C4H6O5.
Fumaric Acid: Not more than 1.0%.
Lead: Not more than 2 mg/kg.
Maleic Acid: Not more than 0.05%.
Optical (Specific) Rotation [α]25°/D: Between −0.10° and +0.10°.
Residue on Ignition: Not more than 0.1%.
Water-Insoluble Matter: Not more than 0.1%.
Maleic Acid BP
C4H4O4 -- 116.1 -- CAS Number 110-16-7
DEFINITION
Maleic acid contains not less than 99.0 per cent and not more than the equivalent of 101.0 per cent of (Z)-butenedioic acid, calculated with reference to the anhydrous substance.
CHARACTERS
A white, crystalline powder, freely soluble in water and in alcohol.
IDENTIFICATION
A. Dilute 5 ml of solution S (see Tests) to 10 ml with water. The pH of the dilution is less than 2.
B. Examine the chromatograms obtained in the test for fumaric acid. The principal spot in the chromatogram obtained with test solution (b) is similar in position and size to the principal spot in the chromatogram obtained with reference solution (a).
C. Dissolve 0.1 g in 10 ml of water (solution a). To 0.3 ml of solution (a) add a solution of 10 mg of resorcinol in 3 ml of sulphuric acid. Heat on a water-bath for 15 min; no color develops. To 3 ml of solution (a) add 1 ml of bromine water. Heat on a water-bath to remove the bromine (15 min), heat to boiling and cool. To 0.2 ml of this solution add a solution of 10 mg of resorcinol in 3 ml of sulphuric acid. Heat on a water-bath for 15 min. A violet-pink colour develops.
TESTS
Solution S: Dissolve 5.0 g in water R and dilute to 50 ml with the same solvent.
Appearance of solution: Solution S is clear and not more intensely coloured than reference solution.
Fumaric acid: To pass the test
Iron: To 10 ml of solution S add 2 ml of dilute hydrochloric acid and 0.05 ml of bromine water. After 5 min, remove the excess of bromine by passing a current of air and add 3 ml of potassium thiocyanate solution. Shake. Prepare a standard at the same time and in the same manner, using a mixture of 5 ml of iron standard solution (1 ppm Fe) R, 1 ml of dilute hydrochloric acid, 6 ml of water and 0.05 ml of bromine water. Allow both solutions to stand for 5 min. Any red colour in the test solution is not more intense than that in the standard (5 ppm).
Heavy metals: 1.0 g complies with limit test D for heavy metals (10 ppm).
Water: Not more than 2.0 per cent, determined on 1.00 g by the semi-micro determination of water.
Sulphated ash: Not more than 0.1 per cent, determined on 1.0 g.
Maleic Acid USP
Maleic Acid
C4H4O4 116.07
(Z)-Butenedioic acid
Cis-Butenedioic acid CAS Number 110-16-7
Maleic Acid contains not less than 99.0 percent and not more than 101.0 percent of C4H4O4, calculated on the anhydrous basis.
Identification:
A: Dissolve about 500 mg of Maleic Acid in 10 mL of water: the pH of the solution is less than 2.
B: To pass chromatography test
C: Dissolve about 35 mg of resorcinol in 10 mL of sulfuric acid (Resorcinol solution). Dissolve about 100 mg of Maleic Acid in 10 mL of water (Test solution). To 0.3 mL of the Test solution add 3 mL of the Resorcinol solution, and heat in a water bath for 15 minutes: no color develops. To 3 mL of the Test solution add 1 mL of bromine TS, heat in a water bath for 15 minutes to remove the bromine, then heat to boiling, and cool. To 0.2 mL of this solution, add 3 mL of the Resorcinol solution, and heat in a water bath for 15 minutes: a violet-pink color develops.
Color and clarity of solution:
Dilute hydrochloric acid solution: Mix 27.5 mL of hydrochloric acid with sufficient water to make 1000 mL.
Reference solution: Mix 2.4 mL of ferric chloride CS and 0.6 mL of cobaltous chloride CS with Dilute hydrochloric acid solution to make 10 mL. Dilute 5 mL of this solution with Dilute hydrochloric acid solution to make 100 mL.
Test solution: Dissolve about 5 g of Maleic Acid in 50 mL of water.
Procedure: Place the Reference solution and the Test solution in matched color-comparison tubes, and compare the solutions by viewing them downward against a white surface : the Test solution is clear and not more intensely colored than the Reference solution.
Water: not more than 2.0% is found.
Residue on ignition: not more than 0.1%, determined on a 1.0-g portion.
Heavy metals: not more than 10 µg per g.
Limit of fumaric acid: To pass the test
Limit of iron: not more than 5 µg per g. |
