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Microcrystalline Cellulose Powder MCCP
CAS Number: 9004-34-6
Microcrystalline Cellulose Powder MCCP
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.
REQUIREMENTS
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%.
We also supply Microcrystalline Cellulose Powder MCCP of BP Ph Eur grade.
Please visit SDS Safety Data Sheet of Microcrystalline Cellulose Powder MCCP Suppliers.
American Molecules, also known as ammol.org is a distributor, supplier and manufacturers' representative of all types of Pharmaceuticals, Functional Ingredients, Excipients and Specialty Chemicals in Texas USA. Our principals manufacture supply and export USP NF BP, Ph Eur, etc grades of chemicals pure and reagent grade, mineral fortifiers, FCC food grade. Tailor made particle size and customized specifications are offered. The principal's facility is having one or more of the certifications like FDA approval and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) for export to Europe is available. The manufacturers suppliers and exporters observe WHO Good Manufacturing Practices and Good Laboratory Practices.
Suppliers and Manufacturers' Representative:
9910 Bent Oak Dr
Houston, TX 77040, USA
Call Toll Free: 1-855-55-AMMOL 1-855-552-6665
Email: info@ammol.org