Malic Acid Pure BP Ph Eur USP NF FCC Food Grade Manufacturers

Muby chemicals, is the flagship company in Mubychem Group, established in 1976, It has several manufacturing units in its wings, making Chemicals including Malic Acid, Pharmaceutical Excipients & Flavour Chemicals in India. Mubychem Group has manufacturing facilities spread across Western India and sales purchase agents in several countries. The associated manufacturing units are accredited with certifications like FDA cGMP and GLP Approval, ISO-9001 ISO-14001, ISO/IEC 17025, ISO-22000, FSSC 22000, ISO 45001, Certification, "REACH" registration, Kosher, Halal & HACCP Certification.

We are chemical supplier exporter to almost every country and have a representatives in major business areas. We serve from small packs to container loads.

Malic Acid USP Grade Specifications
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.

Malic Acid BP 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.

A. R = CO2H, R' = H: (E)-butenedioic acid (fumaric acid),
B. R = H, R' = CO2H: (Z)-butenedioic acid (maleic acid).

Malic Acid FCC Food Grade Specifications
DL-Malic Acid; Hydroxysuccinic Acid;
2-Hydroxybutanedioic Acid
C4H6O5 Formula wt 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%.

Malic Acid BP Ph Eur USP NF FCC Food Grade Manufacturers:

Muby Chemicals & Associated Cos
BANDEALI BUILDING, CHINCHBUNDER, MUMBAI 400009, INDIA.
TEL: 91-22-23728264. Gujarat & Mumbai India.

Exports to USA UAE Europe South Africa Tanzania Kenya Uganda Egypt Nigeria Turkey Brazil Chile Argentina Dubai Cameroon Guatemala Mexico etc.

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