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Malic Acid USP NF BP Pure AR Reagent FCC Food Grade Manufacturers, SDS MSDS Sheet
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
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MSDS Sheet of Malic Acid Manufacturers
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
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).
Malic Acid USP Grade
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.
Malic Acid FCC Food Grade
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.
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Last 23 March, 2017
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Malic Acid GHS SDS MSDS Sheet, Material Safety Data Sheet
1. Product Identification
Synonyms: DL-Hydroxysuccinic acid, DL Malic Acid, (±)-2-Hydroxysuccinic acid
CAS No.: 6915-15-7, ( 617-48-1)
EINICS EC-No.: 230-022-8
Molecular Weight: 134.09
Chemical Formula: C4H6O5
Recommended usage: Industrial Manufacturing.
Suppliers: As per letterhead.
2. Hazards Identification
GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Classification according to Regulation (EC) No 1272/2008
Acute toxicity, oral Category 4
Skin corrosion/irritation Category 2
Serious eye damage/eye irritation Category 2A
Specific target organ toxicity, single exposure; Respiratory tract irritation Category 3
Labelling according to GHS and Regulation (EC) No 1272/2008
GHS Label Elements
Signal Words: Warning
H302: Harmful if swallowed.
H315: Causes skin irritation.
H319: Causes serious eye irritation.
H335: May cause respiratory irritation.
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 authorised agents only.
Labelling in accordance with Directive 67/548/EEC:
Symbols: Xi Irritant
For the full text of the H-statements & R-phrases mentioned in this Section, see Section 16.
HMIS (Perceived): Health hazard: 2, Flammability: 0, Physical hazards: 0
NFPA (Perceived): Health hazard: 2, Fire: 0, Reactivity Hazard: 0
3. Composition/Information on Ingredients
Ingredient: Malic Acid
CAS No.: 6915-15-7 (617-48-1)
EINICS EC-No.: 230-022-8
4. First Aid Measures
Always get medical attention after the first aid is over.
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.
5. Fire Fighting Measures
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.
6. Accidental Release Measures
Small Spill: Use appropriate tools to put the spilled solid in a convenient waste disposal container.
Large Spill: Corrosive solid. Stop leak if without risk. Do not get water inside container. Do not touch spilled material. Use water spray to reduce vapors. Prevent entry into sewers, basements or confined areas; dike if needed. Eliminate all ignition sources.
7. Handling and Storage
Keep Malic Acid in a tightly closed container, stored in a cool, dry, ventilated area. Protect against physical damage. Isolate from incompatible substances. Containers of Malic Acid may be hazardous when empty since they retain product residues (dust, solids); observe all warnings and precautions listed for the product. Avoid dust formation and control ignition sources. Employ grounding, venting and explosion relief provisions in accord with accepted engineering practices in any process capable of generating dust and/or static electricity. Empty only into inert or non-flammable atmosphere. Emptying contents into a non-inert atmosphere where flammable vapors may be present could cause a flash fire or explosion due to electrostatic discharge.
8. Exposure Controls/Personal Protection
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.
9. Physical and Chemical Properties
Appearance: Malic Acid is white to off-white crystals or powder.
Odor: Faint acidulous odor.
Solubility: Soluble in water.
Density: 1,6 g/cm3 at 20 °C
pH: Approximately 2, Acidic.
% Volatile by volume @ 21C (70F): 0
Auto-ignition temperature: 340 °C
Molecular Weight: 134.09
Chemical Formula: C4H6O5
Melting Point: 131 - 133 °C - lit.
10. Stability and Reactivity
Stability: Malic Acid is 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.
11. Toxicological Information
LD50 Oral - Rat - male and female - 3.500 mg/kg
LD50 Intraperitoneal - Rat - 100 mg/kg
LD50 Intraperitoneal - Mouse - 50 mg/kg
Carcinogenic Effects: Not a reported carcinogen by IARC, NTP, ACGIH, OSHA.
12. Ecological Information
Toxicity to daphnia and other aquatic invertebrates:
Immobilization LC50 - Daphnia magna (Water flea) - ca. 240 mg/l - 48 h
Mobility in soil: No data available
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.
13. Disposal Considerations
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.
14. Transport Information
DOT: Not regulated
TDG: Not regulated
IATA: Not regulated
IMDG/IMO: Not regulated
ADR/RID: Not regulated
15. Regulatory Information
TSCA 12(b): Not applicable
SARA 313: Not applicable
SARA 311/312: Acute Health Hazard
Clean Water Act: Not applicable
Clean Air Act: Not applicable
OSHA: Occupational Safety and Health Administration Not applicable
CERCLA: Not applicable
California Proposition 65: This product does not contain any Proposition 65 chemicals
Massachusetts Right To Know Components: No components are subject to the Massachusetts Right to Know Act.
Pennsylvania Right To Know Components: DL-Malic acid, CAS-No. 6915-15-7
New Jersey Right To Know Components: DL-Malic acid, CAS-No. 6915-15-7
Canada WHMIS Hazard: Class D2B Toxic materials
16. Other Information
EINICS EC-No.: 230-022-8
Xi = Irritant
R36/37/38 = Irritating to eyes, respiratory system and skin.
R43 = May cause sensitization by skin contact.
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 (hereinafter "Information") 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.