CAS Number 9004-34-6, Microcrystalline Cellulose USP NF BP Ph Eur FCC Food Grade Manufacturers Exporters
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CAS Number 9004-34-6, Microcrystalline Cellulose USP NF BP Ph Eur FCC Food Grade Manufacturer Exporter
For Properties Specifications of Microcrystalline Cellulose Click Properties, Specifications of Microcrystalline Cellulose Manufacturer.
For Uses of Microcrystalline Cellulose Click Uses of Microcrystalline Cellulose Manufacturer.
For For SDS MSDS Sheet of Microcrystalline Cellulose Click SDS Safety Data Sheet MSDS Sheet of Microcrystalline Cellulose Manufacturer.
The Properties and Specifications of Microcrystalline Cellulose:
Specifications of Microcrystalline Cellulose BP Ph Eur Grade:
C6H(10+2) O(5+1)
Action and use: Excipient.
DEFINITION
Purified, partly depolymerised cellulose prepared by treating alpha-cellulose, obtained as a pulp from fibrous plant material, with mineral acids.
CHARACTERS
Appearance: White or almost white, fine or granular, slightly hygroscopic powder.
Solubility: Practically insoluble in water, in acetone, in anhydrous ethanol, in toluene, in dilute acids and in a 50 g/L solution of sodium hydroxide.
IDENTIFICATION
A. Place about 10 mg on a watch-glass and disperse in 2 mL of iodinated zinc chloride solution. The substance becomes violet-blue.
B. The degree of polymerisation is not more than 350.
TESTS
Solubility: Dissolve 50 mg in 10 mL of ammoniacal solution of copper tetrammine. It dissolves completely, leaving no residue.
pH: 5.0 to 7.5 for the supernatant.
Ether-soluble substances: Maximum 0.05 per cent (5.0 mg) for the difference between the mass of the residue and the mass obtained from a blank determination.
Loss on drying: Maximum 7.0 per cent, determined on 1.000 g by drying in an oven at 105C for 3 h.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.
Microbial contamination:
TAMC: acceptance criterion 1000 CFU/g.
TYMC: acceptance criterion 100 CFU/g.
Absence of Escherichia coli.
Absence of Pseudomonas aeruginosa.
Absence of Staphylococcus aureus.
Absence of Salmonella.
Specifications of Microcrystalline Cellulose USP NF Grade:
Cellulose CAS 9004-34-6
Microcrystalline Cellulose is purified, partially depolymerized cellulose prepared by treating alpha cellulose, obtained as a pulp from fibrous plant material, with mineral acids.
Labeling: The labeling indicates the nominal loss on drying, bulk density and degree of polymerization values. Degree of polymerization compliance is determined using Identification test B. Where the particle size distribution is stated in the labeling, proceed as directed under Particle size distribution. The labeling indicates with which technique the particle size distribution was determined if a technique other than analytical sieving was used; and the labeling indicates the d10, d50, and d90 values and the range for each.
Identification:
A: Prepare iodinated zinc chloride solution by dissolving 20 g of zinc chloride and 6.5 g of potassium iodide in 10.5 mL of water. Add 0.5 g of iodine and shake for 15 minutes. Place about 10 mg of Microcrystalline Cellulose on a watch glass, and disperse in 2 mL of iodinated zinc chloride solution: the substance takes on a violet-blue color.
B: To pass the test. --- The degree of polymerization is not greater than 350.
Microbial limits: The total aerobic microbial count does not exceed 1000 cfu per g, the total combined molds and yeasts count does not exceed 100 cfu per g, and it meets the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas aeruginosa and for absence of Escherichia coli and Salmonella species.
Conductivity: To pass the test. The conductivity of the supernatant does not exceed the conductivity of the water by more than 75 microS per cm.
pH: between 5.0 and 7.5 in the supernatant obtained in the Conductivity test.
Loss on drying: Dry it at 105C for 3 hours: it loses not more than 7.0% of its weight, or some other lower percentage, or is within a percentage range, as specified in the labeling.
Residue on ignition: not more than 0.1%.
Bulk density: ---: the bulk density is within the labeled specification.
Particle size distribution: [NOTE—In cases where there are no functionality-related concerns regarding the particle size distribution of the article, this test may be omitted.] Where the labeling states the particle size distribution, determine the particle size distribution as directed in Particle Size Distribution Estimation by Analytical Sieving, or by a suitable validated procedure.
Water-soluble substances: Shake 5.0 g with about 80 mL of water for 10 minutes, filter with the aid of vacuum through filter paper (Whatman No. 42 or equivalent) into a vacuum flask. Transfer the filtrate to a tared beaker, evaporate to dryness without charring, dry at 105C for 1 hour, cool in a desiccator, and weigh: the difference between the weight of the residue and the weight obtained from a blank determination does not exceed 12.5 mg (0.25%).
Ether-soluble substances: Place 10.0 g in a chromatographic column having an internal diameter of about 20 mm and pass 50 mL of peroxide-free ether through the column. Evaporate the eluate to dryness in a previously dried and tared evaporating dish with the aid of a current of air in a fume hood. After all the ether has evaporated, dry the residue at 105C for 30 minutes, cool in a desiccator, and weigh: the difference between the weight of the residue and the weight obtained from a blank determination does not exceed 5.0 mg (0.05%).
Heavy metals: 0.001%.
Specifications of Cellulose Gel FCC Food Grade:
Cellulose, Microcrystalline
INS: 460 CAS 9004-34-6
DESCRIPTION
Cellulose Gel occurs as a fine, white or almost white powder. It is purified, partially depolymerized cellulose prepared by treating alpha-cellulose, obtained as a pulp from fibrous plant material, with mineral acids. It consists of free-flowing, nonfibrous particles that may be compressed into self-binding tablets that disintegrate rapidly in water. It is insoluble in water, in dilute acids, in dilute sodium hydroxide solutions, and in most organic solvents.
Function: Anticaking agent; binding agent; dispersing agent.
Identification:
A. Sift 20 g of sample for 5 min on an air-jet sieve equipped with a screen having 38-_m openings. If more than 5% is retained on the screen, mix 30 g of sample with 270 mL of water; otherwise, mix 45 g of sample with 255 mL of water. Mix for 5 min in a single-speed, high-speed (equal to or greater than 18,000 rpm) power blender (use a Waring Blender, Model 700G, or equivalent) that has a clover-shaped jar design. The jar and blades meet the following specifications: The jar has a 7.0-cm id at the bottom and a 9.2-cm id at the top and an overall height of 21.9 cm, and the four blades are arranged so that two of the blades are pointed up and two are pointed down. Transfer 100 mL of the dispersion into a 100-mL graduated cylinder and allow it to stand for 3 h. A white, opaque, bubble-free dispersion that does not form a supernatant liquid at the surface is obtained.
B. Add a few drops of iodine to 20 mL of the dispersion obtained in Identification Test A, and mix. No purple to blue or blue color appears.
Assay: Not less than 97.0% and not more than 102.0% of carbohydrate, calculated as cellulose on the dried basis.
Lead: Not more than 2 mg/kg.
Loss on Drying: Not more than 7.0%.
pH: Between 5.0 and 7.5.
Residue on Ignition: Not more than 0.05%.
Water-Soluble Substances: Not more than 0.24%.
The Uses of Microcrystalline Cellulose:
Micro crystalline cellulose is used as a texturizer, an anti-caking agent, a fat substitute, an emulsifier and a bulking agent in food production. It can be used for thickening, bonding, emulsifying, dispersing, stabilizing, preserving water etc.
The MSDS-SDS Hazard Statement of Microcrystalline Cellulose:
Microcrystalline Cellulose Powder MCCP SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 10-Dec-24
Section 1: Chemical Product and Company Identification
Product Name & Other Names: Microcrystalline Cellulose Powder MCCP.
CAS Number: 9004-34-6
EINECS EC Code: 232-674-9
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Suppliers: As per letterhead.
Section 2: Hazards 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 Regulation EC 1272/2008 (CLP) & GHS
GHS Label Elements NONE |
Signal Word: None
Precautionary statements:
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.
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.
Section 3: Composition and Information on Ingredients
Product Name & Other Names: Microcrystalline Cellulose Powder MCCP.
CAS Number: 9004-34-6
EINECS EC Code: 232-674-9
Section 4: First Aid Measures
Always seek medical advice after the first aid treatment.
Skin: Rinse with water. Soap may be used. Seek Medical Aid.
Eyes: Wash eyes with plenty of water for at least 15 minutes, lifting lids occasionally. Seek Medical Aid.
Inhalation: Remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen.
Ingestion: If swallowed, induce vomiting immediately after giving two glasses of water. Never give anything by mouth to an unconscious person.
Section 5: Fire and Explosion Data
Flammability of the Product: Non-flammable.
Products of Combustion: Oxides of Carbon.
Fire Fighting Media and Instructions: Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide. Wear self-contained breathing apparatus for firefighting if necessary. Avoid solid water jet as it can scattter the fire.
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.
Section 6: Accidental Release Measures
Personal precautions, protective equipment and emergency procedures: Avoid breathing dust/fumes/gas/mist/vapors/spray. Ensure adequate ventilation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.).
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. 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. Do not inhale vapors, mist, or gas. Avoid dust formation.
Section 7: Handling and Storage
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. Keep container tightly closed. Avoid ingestion and inhalation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.).
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 inhalation of dust/mist/vapor. Do not store with incompatible materials like oxidizing agents, acids.
Section 8: Exposure Controls/Personal Protection
Exposure Limits: This product does not contain any hazardous materials with occupational exposure limits established by the region-specific regulatory bodies.
Engineering Controls: Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels low.
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 may be worn.
Skin Protection: Wear protective gloves and clean body-covering clothing.
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. Handle in accordance with good industrial hygiene and safety practice. Wash hands after handling.
Section 9: Physical and Chemical Properties
Physical state and appearance: White or almost white, fine or granular powder.
Odor: Odorless.
Odor threshold: No data found.
pH (5% soln/water): 5 to 7.5
Relative density: No data found.
Melting point/freezing point: No data found.
Initial boiling point and boiling range: No data found.
Flash point: No data found.
Auto-ignition temperature: No data found.
Decomposition temperature: No data found.
Upper/lower flammability or explosive limits: No data found.
Vapor pressure: No data found.
Vapor density: No data found.
Evaporation rate: No data found.
Flammability (solid, gas): No data found.
Partition coefficient: n-octanol/water: No data found.
Solubility: Practically insoluble in water, in acetone.
Viscosity: No data found.
Section 10: Stability and Reactivity Data
Stability: It is stable in room temperature in closed containers under normal storage & handling.
Conditions of instability: Incompatible materials, Moisture
Incompatibility with various substances: Avoid high temperatures, sparks, open flames and moisture. Avoid contact with strong oxidizing agents and acids.
Polymerization: Will not occur.
Section 11: Toxicological Information
LD50 Oral - Rat - > 5000 mg/kg
LD50 Dermal - Rabbit - > 2.000 mg/kg.
Carcinogenic Effects: Not listed as probable, possible or confirmed human carcinogen by IARC, NTP, ACGIH, OSHA.
Mutagenic Effects: No data found.
Developmental Toxicity: No data found.
Reproductive Effects: No data found.
Section 12: Ecological Information
Toxicity to fish: No data found.
Persistence and Degradability: No data found.
Mobility: No data found.
Bioaccumulation/ Accumulation: No data found.
Results of PBT and vPvB assessment: No data found for assessment.
Section 13: Disposal Considerations
Waste Disposal: Waste must be disposed of in accordance with federal, state and local environmental control regulations. Follow all the pollution control rules.
Section 14: Transport Information
DOT USA, TDG Canada & ADR/RID Europe: Not controlled.
IMDG/IMO: Not controlled.
IATA: Not controlled.
Section 15: Other Regulatory Information
USA Regulations:
California Prop 65: Not listed.
Disclaimer:
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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.
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Anmol Chemicals & Pharmaceuticals Pvt. Ltd. is an off-shoot of Anmol Chemicals Taloja. It is located in MIDC Taloja and it is manufacturing pharmaceutical grades of API, Excepients, Food grade and Reagent grade chemicals. Anmol Chemicals & Pharmaceuticals Pvt. Ltd. is a several decades old group of companies, engaged in manufacturing, supplying, distributing, wholesale supplies for actual users, retail or small pack supplies for research and development chemicals, fine and speciality chemicals, pharmaceutical excipients, mineral fortifiers in chemically pure, Analytical reagent grade, IP BP USP Ph Eur EP JP and other pharmaceutical grade monograph including FCC Food grade chemicals and Nutraceuticals, Mineral Fortifiers at best prices.
Microcrystalline Cellulose Structure
CAS Number 9004-34-6, Microcrystalline Cellulose Manufacturer Exporter
ANMOL CHEMICALS & PHARMACEUTICALS Pvt. Ltd.
India, USA, Europe, UAE
TELEPHONE: +912223770100
Navi Mumbai, INDIA
e-mail: info(At the rate i.e. @)anmol.org
Copyright. 10-dec-24
We manufacture:
Hypromellose Phthalate or Hydroxypropyl Methycellulose Phthalate