Potassium clavulanate: + MICROCRYSTALLINE CELLULOS (MCC) (1:1)

Molecular Formula

C8H8KNO5

Synonyms

• Potassium clavulanate
• 61177-45-5
• CLAVULANATE POTASSIUM
• Amonate

Chemical Properties

white powder

Chemical Properties

Microcrystalline cellulose and carboxymethylcellulose sodium occurs as a white or off-white odorless and tasteless hygroscopic powder containing 5–22% sodium carboxymethylcellulose. It is a water-dispersible organic hydrocolloid.

Chemical Properties

Microcrystalline cellulose is a purified, partially depolymerized cellulose that occurs as a white, odorless, tasteless, crystalline powder composed of porous particles. It is commercially available in different particle sizes and moisture grades that have different properties and applications.

Occurrence

The fiber in typical paper can be called “cellulosic”, meaning that cellulose is its most prominent component. Cellulose is present not only in wood, but also in various non-woody plants, such as straw, sugarcane (bagasse), reeds, and hemp.

Uses

High purity cellulose powders for partition chromatography.

Uses

ACCEL-101 is most widely used for direct compression tableting and wet granulation. ACCEL-102 has similar compression properties to ACCEL-101. However, it has larger particle size and therefore, may be of value in improving the flow if fine powders. ACCEL

Uses

cellulose is a thickener and an emulsifier. It is obtained from plants. cellulose (microcrystalline) is used as an emulsifier in cosmetic creams. It is the chief constituent of plant fiber.

Uses

Wood contains 50–70% cellulose; cotton and other textile fibers of plant origin contain 65–95%; rayon is prepared by dissolving natural cellulose and then precipitating it from solution, with some loss of crystallinity. Cellulose is made into cellophane film and is used to form fibers, resins, coatings and gums.

Uses

Cellulose is a carbohydrate polymer made up of glucose units. It consists of fibrous particles and is used as a fiber source and bulking agent in low-calorie formulations.

Uses

Microcrystalline Cellulose is a gum that is the nonfibrous form of cellulose, an alpha-cellulose. It is dispersible in water but not soluble, requiring considerable energy to disperse and hydrate. In this form it is used in dry applications such as tableting, capsules, and shredded cheese where it functions as a non-nutritive filler, binder, flow aid, and anticaking agent. By the addition of carboxymethylcellulose to the alpha-cellulose prior to drying, improved functional properties of hydration and dispersion are obtained. This product is designed for use in water dispersions, being insoluble in water but dispersing in water to form colloidal sols below 1% and white opaque gels above the 1% usage level. It is used as a heat shock stabilizer and bodying agent in frozen desserts, as an opacifier in low-fat dressings, as a foam stabilizer in whipped toppings, and as an emulsifier in dressings. Also termed cellulose gel.

Definition

A natural carbohydrate high polymer (polysaccha- ride) consisting of anhydroglucose units joined by an oxygen linkage to form long molecular chains that are essentially linear. It can be hydrolyzed to glucose. The degree of polymerization is from 1000 for wood pulp to 3500 for cotton fiber, giving a molecular weight from 160,000 to 560,000. Cellulose is a colorless solid, d approximately 1.50, insoluble in water and organic solvents. It will swell in sodium hydroxide solution and is soluble in Schweitzer’s reagent. It is the fundamental con- stouten of all vegetable tissues (wood, grass, cotton, etc.) and the most abundant organic material in the world. Cotton fibers are almost pure cellulose; wood contains approximately 50%. The physical structure of cellulose is unusual in that it is not a single crystal but consists of crystalline areas embedded in amorphous areas. Chemical reagents penetrate the latter more easily than the former. Cel- lulose is virtually odorless and tasteless and is com- bustible, with an ignition point of approximately 450F. In some forms, it is flammable. For example, railroad shipping regulations require a flammable label on such items as burnt fiber, burnt cotton, wet waste paper, and wet textiles. Fires have been known to occur in warehouses in which telephone books were stored. These were undoubtedly due to heat buildup in the paper caused by microbial activity and self-sustaining oxidation.

General Description

Odorless, white powdery fibers. Density 1.5 g cm-3. The biopolymer composing the cell wall of vegetable tissues. Prepared by treating cotton with an organic solvent to de-wax Cellulose microcrystalline and removing pectic acids by extration with a solution of sodium hydroxide. The principal fiber composing the cell wall of vegetable tissues (wood, cotton, flax, grass, etc.). Technical uses depend on the strength and flexibility of its fibers. Insoluble in water. Soluble with chemical degradation in sulfuric aicd, and in concentrated solutions of zinc chloride. Soluble in aqueous solutions of cupric ammonium hydroxide (Cu(NH3)4(OH)2).

Reactivity Profile

Cellulose microcrystalline is combustible. Incompatible with strong oxidizing agents including bromine pentafluoride, sodium nitrate, fluorine, perchlorates, perchloric acid, sodium chlorate, magnesium perchlorate, F2, zinc permanganate, sodium nitrite, sodium nitrate, sodium peroxide. Nitration with a mixture of nitric and sulfuric acids produces Cellulose microcrystalline nitrates (celluloid pyroxylin, soluble pyroxyline, guncotton) which are flammable or explosive.

Health Hazard

Cellulose is inert and is classified as a nuisance dust.
It has little, if any, adverse effect on the lung, and there are no reports of organic disease or toxic effect. The health effects attributed to wood, cotton, flax, jute, and hemp are not attributable to their cellulose content but rather to the presence of other substances.
Cellulose fibers were found in the blood and urine of human volunteers fed dyed cellulose; there were no ill effects.

Pharmaceutical Applications

Microcrystalline cellulose and carboxymethylcellulose sodium is used to produce thixotropic gels suitable as suspending vehicles in pharmaceutical and cosmetic formulations. The sodium carboxymethylcellulose aids dispersion and serves as a protective colloid.
Concentrations of less than 1% solids produce fluid dispersions, while concentrations of more than 1.2% solids produce thixotropic gels. When properly dispersed, it imparts emulsion stability, opacity and suspension in a variety of products, and is used in nasal sprays, topical sprays and lotions, oral suspensions, emulsions, creams and gels.

Pharmaceutical Applications

Microcrystalline cellulose is widely used in pharmaceuticals, primarily as a binder/diluent in oral tablet and capsule formulations where it is used in both wet-granulation and direct-compression processes. In addition to its use as a binder/diluent, microcrystalline cellulose also has some lubricant and disintegrant properties that make it useful in tableting.
Microcrystalline cellulose is also used in cosmetics and food products.

Industrial uses

Cellulose is the main constituent of the structure of plants (natural polymer) that, when extracted, is employed for making paper, plastics, and in many combinations. Celluloses made up of long-chain molecules in which the complex unit C6H10O5 is repeated as many as 2000 times. It consists of glucose molecules with three hydroxyl groups for each glucose unit.
One of the simplest forms of cellulose used industrially is regenerated cellulose, in which the chemical composition of the finished productids similar to that of the original cellulose. It is made from wood or cotton pulp digested ins caustic solution. Cellophane is a regenerated cellulose in thin sheets for wrapping and otherspecial uses include windings on wire and cable.

Safety Profile

A nuisance dust. When heated to decomposition it emits acrid smoke and irritating fumes.

Safety

Microcrystalline cellulose is widely used in oral pharmaceutical formulations and food products and is generally regarded as a relatively nontoxic and nonirritant material.
Microcrystalline cellulose is not absorbed systemically following oral administration and thus has little toxic potential. Consumption of large quantities of cellulose may have a laxative effect, although this is unlikely to be a problem when cellulose is used as an excipient in pharmaceutical formulations.
Deliberate abuse of formulations containing cellulose, either by inhalation or by injection, has resulted in the formation of cellulose granulomas.

storage

Microcrystalline cellulose and carboxymethylcellulose sodium is hygroscopic and should not be exposed to moisture. It is stable over a pH range of 3.5–11. Store in a cool, dry place. Avoid exposure to excessive heat.

storage

Microcrystalline cellulose is a stable though hygroscopic material. The bulk material should be stored in a well-closed container in a cool, dry place.

Incompatibilities

Microcrystalline cellulose and carboxymethylcellulose sodium is incompatible with strong oxidizing agents.

Incompatibilities

Microcrystalline cellulose is incompatible with strong oxidizing agents.

Regulatory Status

Microcrystalline cellulose and carboxymethylcellulose sodium is a mixture of two materials both of which are generally regarded as nontoxic:
Microcrystalline cellulose GRAS listed. Accepted for use as a food additive in Europe. Included in the FDA Inactive Ingredients Database (inhalations; oral capsules, powders, suspensions, syrups, and tablets; topical and vaginal preparations). Included in nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients.
Carboxymethylcellulose sodium GRAS listed. Accepted as a food additive in Europe. Included in the FDA Inactive Ingredients Database (dental preparations; intra-articular, intrafusal, intradermal, intralesional, and intrasynovial injections; oral drops, solutions, suspensions, syrups and tablets; topical preparations). Included in nonparental medicines licensed in the UK. Included in the Canadian List of Acceptable Nonmedicinal Ingredients.

Signal

Danger

GHS Hazard Statements

• Aggregated GHS information provided by 57 companies from 9 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.
• H228 (100%): Flammable solid [Danger Flammable solids]
• H252 (75.44%): Self-heating in large quantities; may catch fire [Warning Self-heating substances and mixtures]
• H317 (70.18%): May cause an allergic skin reaction [Warning Sensitization, Skin]
• H319 (22.81%): Causes serious eye irritation [Warning Serious eye damage/eye irritation]
• H334 (70.18%): May cause allergy or asthma symptoms or breathing difficulties if inhaled [Danger Sensitization, respiratory]
• H361 (14.04%): Suspected of damaging fertility or the unborn child [Warning Reproductive toxicity]
• Information may vary between notifications depending on impurities, additives, and other factors. The percentage value in parenthesis indicates the notified classification ratio from companies that provide hazard codes. Only hazard codes with percentage values above 10% are shown.