Malic Acid USP NF IP EP BP Ph Eur Pure FCC Food Grade Manufacturers, with SDS MSDS Sheet

Supplier, Manufacturer, Exporter of Malic Acid USP NF IP EP BP Ph Eur Pure FCC Food Grade, Muby Chemicals of Mubychem Group, established in 1976, is the original manufacturers of Specialty Chemicals, Pharmaceutical Excipient, Fragrance Food & Flavor chemicals, Reagent Grade Chemicals, Shale Gas Fracturing Chemicals in India. Mubychem Group has several manufacturing facilities spread across Western India and world wide contacts and toll manufacturers. We are exporting globally to countries like USA, Canada, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Cameroon, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Dubai, Korea, Vietnam, Thailand, Malaysia, Indonesia, Australia, China, Germany, France, Italy, Portugal, Bangladesh, etc.

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

Specifications, Safety Data Sheet, Manufacturing process details, Wholesale retail buy sell prices, Uses etc available on line in these pages for Malic Acid.

We also offer Coated or Encapsulated Malic Acid for breads, tortilas and other food products. We also manufacture and supply micro-encapsulated Malic Acid.

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.

Malic Acid BP Grade Ph Eur Grade Specifications

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.

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

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.
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%.

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.

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Malic Acid GHS SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 27-Oct-20

Product Name & Other Names: Malic Acid or DL-Hydroxysuccinic acid or DL Malic Acid or (±)-2-Hydroxysuccinic acid.
CAS No.: 6915-15-7, ( 617-48-1)
EINICS EC-No.: 230-022-8
Molecular Weight: 134.09
Chemical Formula: C4H6O5
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Suppliers: As per letterhead.

GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Classification according to Regulation (EC) No 1272/2008

Acute toxicity, oral Category 4, H302
Skin corrosion/irritation Category 2, H315
Serious eye damage/eye irritation Category 2A, H319
Specific target organ toxicity, single exposure; Respiratory tract irritation Category 3, H335

Hazard statements:
H302: Harmful if swallowed.
H315: Causes skin irritation.
H319: Causes serious eye irritation.
H335: May cause respiratory irritation.

Precautionary statements:
P262: Do not get in eyes, on skin, or on clothing.
P264: Wash skin thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P270: Do not eat, drink or smoke when using this product.
P273: Avoid release to the environment.
P330: Rinse mouth.
P362: Take off contaminated clothing and wash before reuse.
P301+312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P332+313: If skin irritation occurs: Get medical advice/attention.
P302+ P352: IF ON SKIN: Wash with plenty of soap and water.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P332+313: If skin irritation occurs: Get medical advice/attention.
P337+P313: If eye irritation persists: Get medical advice/ attention.
P501: Dispose of contents/container to authorized agents only.

Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard Symbol:
Xi = Irritant
Xn = Harmful.
Risk Phrases:
R22 Harmful if swallowed.
R36/37/38 rritating to eyes, respiratory system, and skin.

Product Name & Other Names: Malic Acid or DL-Hydroxysuccinic acid or DL Malic Acid or (±)-2-Hydroxysuccinic acid.
CAS No.: 6915-15-7 (617-48-1)
EINICS EC-No.: 230-022-8

Inhalation: If Malic Acid is inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen and get medical attention immediately.
Ingestion: Never give anything by mouth to an unconscious person. Get medical attention.
Skin Contact: Immediately flush skin with plenty of water for at least 15 minutes while removing contaminated clothing and shoes. Get medical attention. Wash clothing and shoes before reuse.
Eye Contact: Immediately flush eyes with plenty of water for at least 15 minutes, lifting lower and upper eyelids occasionally. Get medical attention immediately.

Fire: As with most organic solids, fire is possible at elevated temperatures or by contact with an ignition source.
Explosion: Fine dust dispersed in air in sufficient concentrations, and in the presence of an ignition source is a potential dust explosion hazard.
Fire Extinguishing Media: Water spray, dry chemical, alcohol foam, or carbon dioxide.
Special Information: In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full face piece operated in the pressure demand or other positive pressure mode. At high temperatures under fire conditions, it may produce toxic or irritating fumes. Fire-extinguishing work is done from the windward and the suitable fire-extinguishing method according to the surrounding situation is used. Uninvolved persons should evacuate to a safe place.

Personal precautions, protective equipment, and emergency procedures: Avoid breathing dust/fumes/gas/mist/vapors/spray. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Restrict unprotected personnel from the area. Prevent any contact with hot surfaces. Do not approach facing the wind. Do not touch the spilled material.
Environmental precautions: Do not let the product enter drains, soil, or water sources.
Methods and materials used for containment Cleanup procedures and Storage:
Small Spill: Use appropriate tools to put the spilled solid in a convenient waste disposal container.
Large Spill: Contain spilled material. Do not let the product enter drains. Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and allow evacuating as per law. Eliminate all ignition sources.

Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. In case of insufficient ventilation, wear suitable respiratory equipment. Wash thoroughly after handling. Do not drink, eat, or smoke while handling. Avoid contact with skin, eyes, and clothing. Minimize dust generation. Avoid breathing dust/fumes/gas/mist/vapors/spray. Avoid contact with eyes, skin, and clothing. Keep container tightly closed. Avoid ingestion and inhalation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Prevent any contact with hot surfaces.
Conditions for safe storage, including any incompatibilities: Store in cool, dry, and ventilated area away from heat sources and protected from sunlight in tightly closed original container. Keep air contact to a minimum. Store protected from heat, sparks and ignition sources and incompatible materials. Avoid contact with skin and eyes. Avoid inhalation of dust/mist/vapor. Do not store with incompatible materials like strong oxidizing agents and bases. Avoid ignition sources and electrostatic discharge.

Airborne Exposure Limits: None established.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible. Local exhaust ventilation is generally preferred because it can control the emissions of the contaminant at its source, preventing dispersion of it into the general work area. Please refer to the ACGIH document, Industrial Ventilation, A Manual of Recommended Practices, most recent edition, for details.
Personal Respirators (NIOSH Approved): For conditions of use where exposure to dust or mist is apparent and engineering controls are not feasible, a particulate respirator (NIOSH type N95 or better filters) may be worn. If oil particles (e.g. lubricants, cutting fluids, glycerin, etc.) are present, use a NIOSH type R or P filter. For emergencies or instances where the exposure levels are not known, use a full-face positive-pressure, air-supplied respirator. WARNING: Air-purifying respirators do not protect workers in oxygen-deficient atmospheres.
Skin Protection: Wear impervious protective clothing, including boots, gloves, lab coat, apron or coveralls, as appropriate, to prevent skin contact.
Eye Protection: Use chemical safety goggles and/or full face shield where dusting or splashing of solutions is possible. Maintain eye wash fountain and quick-drench facilities in work area.
Other Control Measures: Maintain good housekeeping in work area. Dust deposits on floors and other surfaces may pick up moisture and cause the surfaces to become slippery and present safety hazards. Handle in accordance with good industrial hygiene and safety practice. Wash hands after handling.

Appearance: Malic Acid is white to off-white crystals or powder.
Odor: Faint acidulous odor.
Odor threshold: Not available.
pH: Approximately 2, Acidic.
Relative density: around 1.6
Melting Point: 131 - 133 °C - lit.
Initial boiling point and boiling range: Not available.
Flash point: Not available.
Auto-ignition temperature: 340C
Decomposition temperature: Not available.
Upper/lower flammability or explosive limits: Not available.
Vapor pressure: Not available.
Vapor density: Not available.
Evaporation rate: Not available.
Flammability (solid, gas): Not available.
Partition coefficient: n-octanol/water: Not available.
Solubility: Soluble in water.
Viscosity: Not available.
Molecular Weight: 134.09
Chemical Formula: C4H6O5

Stability: Stable under ordinary conditions of use and storage.
Hazardous Decomposition Products: Carbon dioxide and carbon monoxide may form when heated to decomposition.
Hazardous Polymerization: Will not occur.
Incompatibilities: Excessive heat, Strong oxidizers.
Conditions to Avoid: Heat, dusting and incompatibles.

Toxicity to Animals:
LD50 Oral - Rat - male and female - 3.500 mg/kg
LD50 Intraperitoneal - Rat - 100 mg/kg
LD50 Intraperitoneal - Mouse - 50 mg/kg
Carcinogenicity: No component of this product present at levels greater than or equal to 0.1% is identified as possible or confirmed human carcinogen by IARC, ACGIH, OSHA and NTP.
Teratogenic Effects: Not available.
Mutagenic Effects: Not available.
Developmental Toxicity: Not available.
Reproductive Effects: No information available.

Toxicity
Toxicity to daphnia and other aquatic invertebrates: Immobilization LC50 - Daphnia magna (Water flea) - ca. 240 mg/l - 48 h
Mobility in soil: Likely to be mobile due to solubility in water.
PBT & vPvB: This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher.

Whatever cannot be saved for recovery or recycling should be managed in an appropriate and approved waste disposal facility. Processing use or contamination of this product may change the waste management options. State and local disposal regulations may differ from federal disposal regulations. Dispose of container and unused Malic Acid in accordance with legal requirements.

DOT USA, TDG Canada & ADR/RID Europe: Not regulated
IATA: Not regulated
IMDG/IMO: Not regulated.

USA:
SARA 313: Not applicable
SARA 311/312: Acute Health Hazard. See section 2.
California Proposition 65: This product does not contain any Proposition 65 chemicals.

European Labeling in Accordance with EC Directives:
H302 = Harmful if swallowed.
H315 = Causes skin irritation.
H319 = Causes serious eye irritation.
H335 =May cause respiratory irritation.

DISCLAIMER: The information and recommendations set forth herein are presented in good faith and believed correct as of the date hereof. It is compiled from various sources and it is not necessarily all inclusive nor fully adequate in every circumstance. In addition, these suggestions should not be confused with nor followed in violation of applicable laws, regulations, rules or insurance requirements applicable. This MSDS sheet is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product. Individuals receiving the information must exercise their independent judgment in determining its appropriateness for a particular purpose.

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