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for Active Substance to be imported into European Union (EU).Microcrystalline Cellulose MCCP 101, 102, 112, 200 USP NF BP Ph Eur FCC Food Grade Manufacturers
Anmol Chemicals is a manufacturer supplier exporter of Microcrystalline Cellulose MCCP 101, 102, 112, 200 and it offers materials as per IP BP EP Ph Eur USP NF JP FCC Food Grade as per the the latest monograph at best prices. Anmol Chemicals Group, established in 1976, is the pioneer manufacturer of Specialty Chemicals, Pharmaceutical Excipients, Some API, Food Chemicals in India. Anmol Chemicals Group has manufacturing facilities spread across Western India, representatives in Houston, Chicago USA and Dubai, UAE. We also have toll manufacturing units for processing chemicals in a few countries around the world. We make IP, BP, EP, USP, NF, Ph. Eur., JP, FCC or Food Grade, Analytical Reagent Grade, LR or Laboratory Reagent Grades and Pure Grades of various chemicals. All our items are analyzed to meet the required standards. We can supply the product in grams for your laboratory trial and in tons for your plant scale jobs.
We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP BP USP NF Ph Eur EP JP), Specialty Chemicals (Pure/Reagent), Mineral Fortifiers (FCC). Our manufacturing facility is FDA approved and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) is available. Solid materials can be customized for particle size, shape, and bulk density. We observe WHO Good Manufacturing Practices and Good Laboratory Practices. We are a government-recognized STAR Export House and "Authorised Economic Operator (AEO)" per Indian Customs.
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Microcrystalline Cellulose MCCP 101, 102, 112, 200 SDS of Manufacturers
Synonyms: Microcrystalline Cellulose MCCP 101, 102, 112, 200
CAS Number: 9004-34-6, EINECS EC Number: 232-674-9, FEMA: ----,Specifications of Microcrystalline Cellulose USP NF Grade:
Cellulose CAS 9004-34-6Microcrystalline 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 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 Cellulose Gel FCC Food Grade:
Cellulose, Microcrystalline
INS: 460 CAS 9004-34-6DESCRIPTION
REQUIREMENTS
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%.Keywords: Microcrystalline Cellulose MCCP 101, 102, 112, 200 IP BP Ph Eur EP USP Analytical Reagent FCC Food Grade CAS Number 9004-34-6 Manufacturer Supplier Exporter Monograph Uses Chemical Molecular Formula Weight.
Manufacturer Supplier Exporter
ANMOL CHEMICALS
Now maturing as Anmol Chemicals Private Limited
Representatives in Houston, Chicago and New York, USA
TEL: (OFF) +91 22 23726950, +91 22 23774610, +91 22 23723564
Taloja Navi Mumbai, INDIAe-mail: info@anmol.org
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Last updated 29-feb-24Exporters to USA, Canada, UAE, Kuwait, Qatar, Gautemala, Tunisia, Europe, South Africa, Bangladesh, Sri Lanka, Tanzania, Kenya, Egypt, Iraq, Turkey, Israel, Vietnam, Nigeria, Uganda, Brazil, Chile, Argentina, Dubai, UAE, Saudi Arabia, Cameroon, Mexico, Brazil, Chile, Argentina, Korea, Thailand, Malaysia, Indonesia, Jakarta, Australia, China, Germany, France, etc.
Representatives in New York, Houston - Texas, Chicago - Illinois, Los Angeles.
All products are Sold for Industrial and Laboratory Use only. No other use is permitted.
Fast Selling IP BP Ph Eur EP USP NF JP Analytical Reagent FCC Food Grades of Chemicals by Anmol Chemicals
Ammonium Persulfate --- Acetic Acid Glacial --- Aluminum Chloride --- Ammonium bicarbonate --- Benzyl Alcohol --- Butylated Hydroxyanisole --- Butylated Hydroxytoluene --- Boric Acid --- Calcium Butyrate --- Calcium Chloride --- Calcium Hydroxide --- Calcium Lactobionate --- Calcium Saccharate --- Carbamide Peroxide --- Calcium Oxide --- Calcium Sulfate --- Chromic Chloride --- Fumaric Acid --- Magnesium Butyrate --- Magnesium Chloride --- Magnesium Sulfate --- Malic Acid --- Maleic Acid --- Manganese Chloride --- Manganese Sulfate --- Octyldodecanol --- Oleic acid --- Phenylethyl Alcohol --- Propylene Carbonate --- Potassium Hydroxide Pellets --- Potassium Alum --- Selenious Acid --- Sodium Acetate --- Sodium Bromate --- Sodium Selenite --- Sodium Perborate --- Sodium Hydroxide --- Sodium Sulphate --- Sodium Sulfide --- Sodium Thiosulfate --- Urea --- Zinc Chloride --- Zinc Sulphate ---Microcrystalline Cellulose
MCCP 101, 102, 112, 200 BP Ph Eur USP NF FCC Food Grades Manufacturers