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Malic Acid Manufacturer Exporter BP Ph Eur USP FCC Food Grade Manufacturer Exporter

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Malic Acid SDS of Manufacturers

Malic Acid IP BP Ph Eur USP NF FCC Food AR ACS Reagenr Grade Manufacturers

CAS Number 6915-15-7 and 97-67-6 Malic Acid, EINECS: 230-022-8 & 202-601-5, Molecular Weight: 134.09, Chemical Formula: C4H6O5

Malic Acid USP Grade Specifications
C4H6O5 134.09
Hydroxybutanedioic acid, (±)-.
(±)-Malic acid.
(±)-Hydroxysuccinic acid CAS 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.

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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: 128C to 132C.
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).
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.

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Malic Acid FCC Food Grade Specifications
DL-Malic Acid; Hydroxysuccinic Acid;
2-Hydroxybutanedioic Acid
C4H6O5 Formula weight 134.09
INS: 296 CAS 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 130C.
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%.

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Last updated 11/19/2022

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