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We are manufacturer of Specialty chemicals, Pharmaceutical Excipients, Fragrance & Flavorchemicals in India, which are of IP, BP, USP, Ph. Eur., FCC or Food Grade, ACS, AR or Analytical Reagent Grade, LR or Laboratory Reagent Grade, Pure and Technical Grades of various chemicals.
Malic acid is an organic compound with the formula HO2CCH2CHOHCO2H. It is a dicarboxylic acid that is made by all living organisms, contributes to the pleasantly sour taste of fruits, and is used as a food additive. Malic acid has two stereoisomeric forms (L- and D-enantiomers), though only the L-isomer exists naturally. Malic acid, when added to food products, is denoted by E number E296. Malic acid is the source of extreme tartness in USA-produced confectionery, the so-called extreme candy. It is also used with or in place of the less sour citric acid in sour sweets.
C4H6O5 — 134.1 — 6915-15-7
Action and use: Excipient.
Content: 99.0 per cent to 101.0 per cent (anhydrous substance).
Appearance: White or almost white, crystalline powder.
Solubility: Freely soluble in water and in alcohol, sparingly soluble in acetone.
A. Melting point: 128°C to 132°C.
B. Infrared absorption spectrophotometry.
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.
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.
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.
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).
Hydroxybutanedioic acid, (±)-.
(±)-Hydroxysuccinic acid [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.
DL-Malic Acid; Hydroxysuccinic Acid;
C4H6O5 Formula wt 134.09
INS: 296 CAS: [617-48-1]
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.
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%.
For Original Monographs of IP Indian Pharmacopoeia BP British Pharmacopoeia USP US Pharmacopoeia FCC Food Grade product, please check with the respective web-pages or books.