Mubychem Group, established in 1976, is the pioneer manufacturer of Malic Acid, Pharmaceutical, Fragrance & Flavor chemicals in India. Mubychem Group has several manufacturing facilities spread across Gujarat and Mumbai India and world wide contacts and toll manufacturers. We are exporting globally to countries like USA, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Dubai, Indonesia, Spain etc. |
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The participating units have one or more accreditations like FDA - GMP approval; ISO-9001 Certified; "REACH" Pre-registered; ISO-22000; Kosher Certified; Halal Certified; HACCP. We offer Pure & IP BP USP FCC Food Grade ACS AR Analytical Reagent Grades of Chemicals |
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Malic Acid BP Ph Eur USP NF FCC Food Grade Manufacturers
For MSDS Sheet Click
Malic Acid MSDS Sheet
Malic Acid
Pure
CAS Number 6915-15-7 & 617-48-1, BP Ph Eur USP NF FCC Food Grades
Malic Acid BP Grade Ph Eur Grade Specifications
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 (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.
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 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.
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 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 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%.
Malic Acid BP USP NF FCC Food Grade Manufacturers:
MUBYCHEM GROUP
CHINCHBUNDER, MUMBAI 400009, INDIA
TEL: (OFFICE)
91-22-23774610, 91-22- 23723564. 91-22-23728264
e-mail: info@mubychem.com
USA & Canadian Customers may e-mail: us@mubychem.com
Global or International Malic Acid BP USP NF FCC Food Grade --- Suppliers, Exporters, Importers, Manufacturers
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29-Apr-2022