Microcrystalline cellulose avicel, fmc corporation is prepared by acid hydrolysis of cellulose using 2 m hydrochloric acid at 105 c for 15 min. Portions of this monograph that are national usp text, and are not part of the harmonized text, are marked with symbols to specify this fact. Ep0942950b1 coprocessed microcrystalline cellulose and. Fine dust dispersed in air in sufficient concentrations, and in the presence of an ignition source, is a potential dust explosion hazard. Microcrystalline cellulose is an ingredient found in many prescription drugs for allergies, inactive or overactive thyroid, blood pressure and other diseases. Prosolv smcc, silicified microcrystalline cellulose, is a unique combination of microcrystalline cellulose mcc and colloidal silicon dioxide csd. Microcrystalline cellulosemcc cellulose ethershpmccmc. Usp is not responsible for the accuracy or completeness of the information furnished. Place about 10 mg of silicified microcrystalline cellulose on a watch glass, and disperse in 2 ml of iodinated zinc. With a wide range of chemical, technical, and economic benefits, mcc is one of the most widely used binder excipients for tablet formulations.
Microcrystalline cellulose is a purified partially hydrolyzed cellulose widely used as anticaking agent, a fat substitute, an emulsifier, an extender, and a bulking agent in food and beverage. It contains sections that describe 14 of the 40 functional categories identi. Pharmacel 102 microcrystalline cellulose mcc compacts more effectively than any other excipient making pharmacel 102 the ideal choice for direct compression and dry granulation formulations. Usps revision of the standard for microcrystalline cellulose has been approved by the pharmacopeial discussion group pdg. Applications and uses of microcrystalline cellulosefoodchem. It is insoluble in water, dilute acids and most organic solvents, but slightly soluble in the alkali solution of 20%. Silicified microcrystalline cellulose pdf silicified microcrystalline cellulose smcc is a novel tableting excipient which. The microcrystalline cellulose monograph will be incorporated into and become official with the second supplement to the usp 42 nf 37. Microcrystalline cellulose is a widely used excipient, an inert substance used in many pill and tablet formulations. Acecel 101 specification fine or granular, white or almost white powder. Jan 10, 2014 beware of cellulose as a filler in food products.
Prosolv smcc silicified microcrystalline cellulose jrs pharma. Should you have any questions about the microcrystalline cellulose monograph, please contact dr. Pdf preparation of microcrystalline cellulose from cotton and its. As a anticaking agent, a fat substitute, an emulsifier, an extender, and a bulking agent, microcrystalline cellulose can be used in a wide variety of. Londonbusiness wiretechnavio has announced the top five leading vendors in their recent global microcrystalline cellulose market 2017. The products, processes and uses of such products referred to in this document. As early as 1969, safanova and klenkova had described the heterogeneous benzoylation of microcrystalline cellulose. The side effects of microcrystalline cellulose synonym. Pdf microcrystalline cellulose mcc is pure partially depolymerized cellulose. Sep 25, 2017 londonbusiness wiretechnavio has announced the top five leading vendors in their recent global microcrystalline cellulose market 20172021 report. Microcrystalline cellulose is the same as cellulose, except that it meets usp standards. You created this pdf from an application that is not licensed to print to. It meets the requirements of the tests for absence of staphylococcus definition aureus and pseudomonas aeruginosa and for the absence of microcrystalline cellulose is purified, partially depolymerized celescherichia coli and salmonella species.
Tablets can be formed that are hard, but dissolve quickly. The acceptable daily intake adi of three of the excipients microcrystalline cellulose, stearic acid, and talc was designated as not specified through the evaluations. Preparation of microcrystalline cellulose from cotton and its. Microcrystalline cellulose mcc is a term for refined wood pulp and is used as a texturizer, an anticaking agent, a fat substitute, an emulsifier, an extender, and a bulking agent in food production. All spectrum chemical nf grade products are manufactured, packaged and stored under current good manufacturing practices cgmp per 21cfr part 211 in fda registered and inspected facilities. Microcrystalline cellulose is widely used as stabilizer, anticaking agent, fat substitute and emulsifier in food production. Usp certificates and valid use dates for previous lots view harmonized system hs code. Microcrystalline cellulose 102 also exhibits excellent properties as an excipient for solid dosage forms. The products, processes and uses of such products referred to in this document may be covered by one or more patents or pending. Microcrystalline cellulose, nf 9004346 c1679 spectrum. Portions of this monograph that are national usp text, and are not part of the harmonized text, are marked with.
Transfer 100 mg to a glassstoppered flask, and add 25. It has excellent compressibility properties and is used in solid dose forms, such as tablets. Repeat the procedure without the substance being examined r2. Microcrystalline cellulose excipients manufacturers.
Powder and mechanical properties of microcrystalline. General chapter viscosity reference corrections in. It compacts well, has high binding capability and creates tablets that are hard, stable, yet disintegrate rapidly. Microcrystalline cellulose grade 12 versus classic grade 102 masaki hasegawa masaki hasegawa is a management representative at long pharm research, 23016 makinogo shuzenjicho, tagatagun, shizuokaken 4102401, japan, tel. Safety data sheet microcrystalline cellulose date prepared. We are a coveted entity of this specified arena, engaged in manufacturing and supplying a durable assortment of micro crystalline cellulose. Top 5 vendors in the global microcrystalline cellulose. Silicified microcrystalline cellulose inactive ingredient. Silicified microcrystalline cellulose pdf semantic scholar. Microcrystalline cellulose 102 usp 1kg tablet press club. Tablets made using pharmacel 101 show excellent compaction and disintegration properties. For usp practically insoluble in sodium hydroxide solution 1 in 20 insoluble in water in dilute acids and in most organic solvents. Mim 606197 and plays a role in an early step of neural development bellefroid et al. Microcrystalline cellulose is a commonly used excipient in the pharmaceutical industry.
General chapter viscosity reference corrections in monographs type of posting. Safety data sheet 109122 microcrystalline cellulose 102 ph. Microcrystalline cellulose mcc was prepared by acid hydrolysis from. Nowadays, a methanolwater solution containing about 40% of the.
Jul 17, 2015 microcrystalline cellulose e460 is considered safe by fda. Jecfa 2000 and published in combined compendium of food additive specifications, fao jecfa monographs 1, vol. Immediately purge the solution with nitrogen, insert the stopper, and shake on a wrist action shaker or other suitable mechanical shaker until completely dissolved. Microcrystalline cellulose microcrystalline cellulose.
Microcrystalline cellulose mcc is an odorless, tasteless, porous white powder derived from pharmaceutical grade wood pulp. Each tablet contains 500 mg of chloroquine phosphate usp, equivalent to 300 mg chloroquine base. Irx3 is a member of the iroquois homeobox gene family see irx1. Besides, it also serves as a strong dry binder, tablet disintegrant, absorbent, filler or diluent, a lubricant, and antiadherent. Dissolve 15 g, calculated with reference to the anhydrous substance,in85gofamixtureof1partofwater r and 249 parts ofacetone r. Microcrystalline cellulose is purified, partially depolymerized cellulose prepared by treating alpha cellulose, obtained as a pulp from fibrous plant material, with mineral acids. Holtzapple, in encyclopedia of food sciences and nutrition second edition, 2003. Connect the flask to a reflux condenser, and reflux for. The highly reactive amorphous regions selectively hydrolyze, releasing the crystallites, which are subsequently mechanically dispersed. Carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene.
The difference between the titrations represents the amount of ferrous ammonium sulfate required. United states pharmacopeia and formulary usp 29 nf. Jecfa 2017 and published in fao jecfa monographs 20 2017, superseding specifications prepared at the 55. Top 5 vendors in the global microcrystalline cellulose market. Better consult to your doctor if you would like to intake microcrystalline cellulose. Microcrystalline cellulose mcc is a freeflowing crystalline powder a nonfibrous microparticle. Based on the single factor experiment results, the hydrolysis conditions were optimized by an orthogonal l 9 3 4 experiment. Silicified microcrystalline cellulose united states pharmacopeia usp reference standard. Transfer an appropriate volume of the percentage of free acid, b, by the formula. If breathing is irregular or stops, perform artificial respiration. Microcrystalline cellulose is refined from insoluble plant fiber.
Hicel 50m specification fine or granular, white or almost white powder. Results showed that the degree of polymerization dp and yield of mcc were strongly influenced by the time and temperature of hydrolysis, the concentration of. For any questions about the pdg and its processes, please see. Safety data sheet 109122 microcrystalline cellulose 102. Dissertationes biocentri viikki universitatis helsingiensis 92001, 58 pp. Nanostructure formation article pdf available in cellulose chemistry and technology 405. Silicified microcrystalline cellulose united states. Microcrystalline cellulose prepared at the 55th jecfa 2000 and published in fnp52 add 8 2000, superseding specifications prepared at the 51st jecfa 1998 and published in fnp 52 add 6 1998.
The most common form is used in vitamin supplements or tablets. There is a lot of concern about diet and nutrition for these population, like newborns, children, pregnant, sensitive to lmalic acid populations. Briefing microcrystalline cellulose, nf 22 page 2845 and. The microcrystalline cellulose monograph will be incorporated into and become official with the second supplement to the usp 42nf 37. Pdf microcrystalline cellulose mcc was prepared by acid hydrolysis from the. The new usp microcrystalline cellullose monograph pdf. Microcrystalline cellulose and carboxymethylcellulose sodium typical properties, packaging note. Cellulose microcrystalline nf ph102 about fagron fagrons strategy is focused on the optimization and innovation of pharmaceutical compounding. Microcrystalline cellulose side effects, side effects of. It compacts well under minimum compression pressures, has high binding capability, and creates tablets that are extremely hard, stable, yet disintegrate rapidly.
Microcrystalline cellulose 101 exhibits excellent properties as an excipient for solid dosage forms. B the author compared the behavior of two grades of microcrystalline cellulose during. Thalitone chlorthalidone tablets usp 15 mg and 25 mg. Proposed new usp general information chapter, excipient. Pharmacel 101 microcrystalline cellulose mcc is also an ideal excipient for use in dry granulated formulations. Microcrystalline cellulose and carboxymethylcellulose sodium. Microcrystalline cellulose mcc sidleycel microcrystalline cellulose mcc is white powder, insoluble in organic solvents or oil, can be partially soluble in alkaline solution, swell and absorbs water 23 times, oil 1. Direct compression microcrystalline cellulose grade 12 versus. If it comes from a vegetable source that is ok, if it does not specify, it means it came from, wood pulp steer clear of any and all products that use microcrystalline cellulose whose source is not indicated. Microcrystalline cellulose mcc is pure partially depolymerized cellulose synthesized from. Not less than 97% of carbohydrate calculated as cellulose on the dry basis. A high functionality and multifunctional excipient, it requires less complex processing, has high inherent functionality, and passes that functionality on to the drug formulation.
Electron microscopical lattice images were obtained with microcrystalline cellulose from ramie. The new usp microcrystalline cellullose monograph pdf download available united states pharmacopoeia the revision to the harmonized standard for microcrystalline cellullose has been approved by the pharmacopeial discussion group pdg as described in its pdg signoff cover sheet. Microcrystalline cellulose, nf is an excipient in pharmaceutical formulations acting as a binder in tablet formation. Microcrystalline cellulose mcc was prepared from oolong tea waste by acid hydrolysis in the present study. In addition to enhanced strength, silicified microcrystalline cellulose compacts exhibited greater. Place about 10 mg of microcrystalline cellulose on a watch glass, and disperse in 2 ml of iodinated zinc chloride solution. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics. The mcc can be synthesized by different processes such as reactive extrusion, enzyme mediated, steam explosion and acid hydrolysis. Microcrystalline cellulose as pharmaceutical excipient intechopen. Its versatility in direct compression extends to very high dose actives, where compactability is at a premium. Sample solution to a calibrated number 150 cannonfenske, or equivalent, viscometer. It is also used in plaque assays for counting viruses, as an alternative to carboxymethylcellulose.
Micro crystalline cellulose is a term for refined wood pulp and is used as a texturizer, an anticaking agent, a fat substitute, an emulsifier and a bulking agent in food production. Wet granulation with pharmacel 101 is a reliable, easily repeatable and robust process. Fmc corporation is owner andor licensee of several patents related to its products. Microcrystalline cellulose an overview sciencedirect. Particulate pharmaceutical tablet excipient compositions comprising coprocessed microcrystalline cellulose and particulate usp calcium carbonate having a particle size distribution of 7 to 22 mu m wherein the range of calcium carbonate to microcrystalline cellulose is 70. It has a wide range of uses in the pharmaceutical excipients and can be directly. Microcrystalline cellulose is also found in weight training products such as fusion bodybuilding zeus, a testosterone booster, eca xtreme fat burner, and six star nitric oxide to name a few. Andreeva3 1 kyrgyz national university, kyrgyzstan 2ariel university, ariel, israel 3kyrgyz russian slavonic university, kyrgyzstan abstract microcrystalline cellulose mcc was extracted from cotton waste. Effect of crystallinity of microcrystalline cellulose on the compactability and dissolution of tablets. All values are presented only for the purpose of basic reference and not as specifications. As an insoluble fiber, microcrystalline cellulose is not absorbed into the blood stream, so. Preparation and characterization of microcrystalline.