Erythritol USP NF BP Ph Eur Grade Manufacturers, with SDS GHS MSDS Sheet
Supplier, Manufacturer, Exporter of Erythritol, 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 etc.
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Erythritol: CAS Number: 149-32-6, EINECS EC Number: 205-737-3, Molecular Formula: C4H10O4 or HOCH2[CH(OH)]2CH2OH, Molecular Weight: 122.12, HS Code ---**
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SDS MSDS Sheet of Erythritol Manufacturers
USP NF BP Ph Eur Grade Pure Suppliers
Erythritol is a type of sugar alcohol. The United States Food and Drug Administration (FDA) approved erythritol for use as a food additive in USA. It has E number E968. Erythritol has the lowest calorie content of any sugar alcohol.
General Specifications of Erythritol Commercial Pure:
Assay: 99.5 – 100.5 %
Lead: 0.5 mg/kg maximum.
Loss on Drying: 0.2 % maximum.
Reducing Sugars (as Glucose): 0.3 % maximum.
Reducing Substances (as D-Glucose): 0.3 % maximum.
Residue on ignition (sulfated ash): 0.1 % maximum.
Conductivity: 20 µS/cm maximum.
Ribitol & Glycerol: 0.1 % maximum.
Specifications of Erythritol BP Ph Eur Grade:
C4H10O4 --- 122.1 --- CAS 149-32-6
Action and use: Excipient.
Content: 96.0 per cent to 102.0 per cent (anhydrous substance).
Appearance: White or almost white, crystalline powder or free-flowing granules.
Solubility: Freely soluble in water, very slightly soluble in ethanol (96 per cent).
A. Melting point: 119C to 122C.
B. Infrared absorption spectrophotometry.
Appearance of solution: The solution is clear and colourless.
Dissolve 5.0 g in water and dilute to 50 mL with the same solvent.
Conductivity: Maximum 20 microS⋅cm-1.
Dissolve 20.0 g in carbon dioxide-free water prepared from distilled water and dilute to 100.0 mL with the same solvent. Measure the conductivity of the solution, while gently stirring with a magnetic stirrer.
Related substances: To pass the test.
— any impurity: not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (2.0 per cent);
— total: not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (2.0 per cent);
— disregard limit: area of the principal peak in the chromatogram obtained with reference solution (c) (0.1 per cent).
Lead: Maximum 0.5 ppm.
Water: Maximum 0.5 per cent, determined on 1.00 g.
If intended for use in the manufacture of parenteral preparations:
— TAMC: acceptance criterion 100 CFU/g.
If not intended for use in the manufacture of parenteral preparations:
— TAMC: acceptance criterion 1000 CFU/g;
— TYMC: acceptance criterion 100 CFU/g;
— absence of Escherichia coli;
— absence of Salmonella.
If intended for use in the manufacture of parenteral preparations without a further appropriate procedure for the removal of bacterial endotoxins:
— less than 4 IU/g for parenteral preparations having a concentration of 100 g/L or less of erythritol;
— less than 2.5 IU/g for parenteral preparations having a concentration of more than 100 g/L of erythritol.
The label states where applicable, that the substance is suitable for use in the manufacture of parenteral preparations.
A. 4-O-α-D-glucopyranosyl-D-glucitol (D-maltitol),
B. D-glucitol (D-sorbitol),
C. (2R,3s,4S)-pentane-1,2,3,4,5-pentol (meso-ribitol),
D. propane-1,2,3-triol (glycerol).
Specifications of Erythritol USP NF Grade:
C4H10O4 --- 122.12
Butane 1,2,3,4-tetrol (meso-erythritol) --- CAS 149-32-6.
Erythritol is obtained by fermentation of starch enzyme hydrolysate (from starches such as wheat and corn). It is obtained from the fermentation broth of suitable osmophilic yeasts such as Moniliella pollinis or Trichosporonoides megachiliensis. It contains NLT 96.0% and NMT 102.0% of erythritol (C4H10O4), calculated on the anhydrous basis.
A. Infrared Absorption.
B. Melting Range or Temperature: 119C –123C
Assay: Acceptance criteria: 96.0%–102.0% on the anhydrous basis
Residue on Ignition: NMT 0.1%
Limit of Lead: To pass the test Acceptance criteria: NMT 0.5 micro-gm/g
Individual impurities: NMT 2.0%
Total impurities: NMT 2.0%
Microbial Enumeration Tests and Tests for Specified Microorganisms: The total aerobic microbial count using the Plate-Count Methods is NMT 1000 cfu/g, and the total combined molds and yeasts count is NMT 100 cfu/g. It meets the requirements of the tests for absence of Salmonella species and Escherichia coli.
Loss on Drying: Dry the Sample at 105C for 4 h. Acceptance criteria: NMT 0.2%.
Water Determination: NMT 0.5%
Conductivity: Acceptance criteria: NMT 20 microS/cm
Packaging and Storage: Preserve in well-closed containers. Store at room temperature.
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 26 August, 2022
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Erythritol SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 18-Oct-20
1. PRODUCT DESCRIPTION
Product Name & Other Names: Erythritol.
CAS Number: 149-32-6
EINECS EC Number: 205-737-3
Molecular Weight: 122.12
Molecular Formula: C4H10O4 or HOCH2[CH(OH)]2CH2OH
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Supplier: As per letterhead.
2. HAZARD IDENTIFICATION
GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Hazard Class and Category Code(s), Regulation (EC) No 1272/2008 (CLP)
Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008.
This substance is not classified as dangerous according to Directive 67/548/EEC.
Labeling as per GHS & Regulation EC 1272/2008 (CLP) & GHS
GHS Label Elements
Signal Words: None
Hazards not otherwise classified (HNOC):
May causes mild skin irritation.
May causes mild eye irritation, if exposed in large quantity.
P261: Avoid breathing dust/fume/gas/mist/vapors/spray.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
P302+P352 - IF ON SKIN: Wash with plenty of soap and water.
P303+P361+P353 - IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower.
P304 + P340 - IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P305 + P351 + P338 - IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+313: If eye irritation persists get medical advice/attention.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Product Name & Other Names: Erythritol.
CAS Number: 149-32-6
EINECS EC Number: 205-737-3
4. FIRST AID MEASURES
Always get medical attention after the first aid is over.
Emergency and First Aid Procedures:
Eyes - Flush with water for at least 15 minutes, raising and lowering eyelids occasionally. Get medical attention if irritation persists.
Skin - Thoroughly wash exposed area for at least 15 minutes. Remove contaminated clothing. Launder contaminated clothing before reuse. Get medical attention if irritation persists.
Ingestion - If it is swallowed, if conscious, give plenty of water. Immediately call a physician. Never give anything by mouth to an unconscious person.
Inhalation - Remove to fresh air. Give oxygen if breathing is difficult; give artificial respiration if breathing has stopped. Get medical attention.
5. FIREFIGHTING PROCEDURES
Extinguisher Media: Use media suitable to extinguish surrounding fire. Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.
Flammable Limits in Air % by Volume: N/A
Special hazards arising from the substance or mixture: Carbon oxides and fumes.
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.
6. SPILL OR LEAK PROCEDURES
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: Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g. sand, earth, diatomaceous earth, vermiculite). Vacuum or sweep up and remove to an approved disposal container.
7. SPECIAL PRECAUTIONS
Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. 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. Do not leave the material container open. 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 oxidizing agents and strong bases.
8. SPECIAL PROTECTION INFORMATION
Respiratory Protection (Specify Type): This product does not contain any hazardous materials with occupational exposure limits established by the region-specific regulatory bodies. NIOSH approved equipment should be worn if PELs are exceeded.
Ventilation Local Exhaust: Yes
Eye Protection: Splash proof chemical safety goggles should be worn at all times.
Other Protective Clothing or Equipment: Lab apron, eye wash, and safety shower.
9. PHYSICAL DATA
Appearance and Odor: White crystalline powder, granules or crystals.
Odor threshold: Not available.
pH: Not available.
Relative density: Not available.
Melting Point: 119C to 123C.
Boiling Point: 329C to 331C
Flash point: Not available.
Auto-ignition temperature: Not available.
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(ies): Soluble in water.
Viscosity: Not available.
Molecular Weight: 122.12
Molecular Formula: C4H10O4 or HOCH2[CH(OH)]2CH2OH.
10. REACTIVITY DATA
Stability: It is stable
Conditions to Avoid: Heat, Dust generation.
Incompatibility (Materials to Avoid): Oxidizing agents, strong bases.
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, fumes.
Hazardous Polymerization: Will not occur
11. TOXICITY DATA
LD50 Oral - Rat - 13100 mg/kg
LD50 Intraperitoneal - Mouse - 7.000 mg/kg.
Carcinogenicity: This product present at levels greater than or equal to 0.1% is identified as probable, possible or confirmed human carcinogen by IARC, NTP, ACGIH & OSHA.
Mutagenic Effects: Not available.
Developmental Toxicity: Not available.
Reproductive Effects: No information available.
12. ECOLOGICAL DATA
Toxicity to fish: No information available.
Toxicity to daphnia and other aquatic invertebrates: No information available.
Bioaccumulative potential: Not likely to bioaccumulate.
Mobility: Will likely be mobile in the environment due to its water solubility.
Results of PBT and vPvB assessment: No data available for assessment.
13. DISPOSAL INFORMATION
Waste Disposal Methods: Dispose in accordance with all applicable Federal, State and Local regulations.
14. TRANSPORT INFORMATION
DOT USA & ADR/RID Europe: Not regulated.
IMDG: Not regulated.
IATA: Not regulated.
15. REGULATORY INFORMATION
SARA 302: No chemicals in this material are subject to the reporting requirements of SARA Title III, Section 302.
SARA 313: This material does not contain any chemical components with known CAS numbers that exceed the threshold (De Minimis) reporting levels established by SARA Title III, Section 313.
SARA 311/312 Hazards: No SARA Hazards
California Prop. 65 Components: This product does not contain any chemicals known to State of California to cause cancer, birth defects, or any other reproductive harm.
16. ADDITIONAL INFORMATION
Our company provides this MSDS sheet in good faith but makes no representation as to its comprehensiveness or accuracy. This SDS sheet is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product. The above information has been compiled from various sources and has the possibility of discrepancy and being out-dated information. Individuals receiving the information must exercise their independent judgment and do further search in determining its appropriateness for a particular purpose. In no case shall our company be liable to loss or damages by the product user.