Manufacturing Excipients

MANUFACTURING EXCIPIENTS

Common Name Official description Chemical formula Solubility UsesAcetaminophen Acetamide, N-(4-

hydroxymethyl), N-acetyl-p-amino phenol, p-acetamidophenol, paracetamol

White, odorless, crystalline powder with slightly bitter taste

C8H9NO2 1g in 70ml water, 20ml boiling water, 50ml chloroform, 40ml glycerin, slightly soluble in ether

Analgesic, antipyretic

Aluminum hydroxide

Colloidal aluminum hydroxide, amphogel aluminum hydroxide

White viscous suspension form which small amounts of water may separate on standing; translucent in thin layers affects both red and blue litmus paper, slightly but is not reddened by phenolphthalein

Al(OH)3 0.0001g/100ml (20oC) water, soluble in acids, alkalies and HCL

Antacid, skin protectant and mild astringent

Ammonium chloride Aluminum trichloride White or yellowish white crystalline powder, deliquescent sweet astringent taste

NH4Cl 1g in o.9ml water, 4ml alcohol, soluble in glycerin

Astringent and anhidrotic especially in the treatment of soggy athlete foot and to enhance efficacy of antifungal drugs

Anhydrous lanolin Wool Fate USP, Refined wool fat

Yellow tenacious, unctuous mass

About twice its weight in water; sparingly soluble in cold alcohol; more soluble in hot water, freely soluble in ether

Gives distinctive quality to ointment


and chloroformAnise oil Aniseed oil, Star anise

oilColorless or pale yellow, strongly refractive liquid having the characteristic odor and taste of anise

Soluble I,n 3volume of 90% alcohol

Flavoring agent for licorice candies, carminative in a dose of about 0.1ml

Avicel Microcrystalline cellulose, cellulose gel, sodium salt, cellulose gum

Forms a three dimensional matrix comprised of millions of insoluble microcrystals that form an extremely stable, thixotropic gel, water dispersible, spray dried blend microcrystalline cellulose and carboxymethyl cellulose

C6H10O5 dispersible Viscosity regulators and modifiers thus preventing caking or sedimentation in suspensions

Banana flavor Banana heart Smoky, slightly cooling and delicately fragrant

Insoluble in water, soluble in alcohol

Flavoring agent

Bentonite powder Wilhinite, soap clay, mineral soap

Very fine, odorless powder with a slightly earthy taste, free from grit, the powder is nearly light but maybe pale buff or cream colored

Insoluble in water or acids

Protective colloid for the stabilization os suspensions, emulsifier for oil and as a base for plasters and ointments

Bergamot Bergamot oil Has the odor of basically citrus, yet fruity and sweet with a warm spicy floral quality

Soluble in alcohol and oils; insoluble in water

Antiseptic, antispasmodic, flavoring agent


Bismuth subnitrate Basic BiHNO3, bismuth oxynitrate, Spanish white, bismuth paint, bismuth nitrate

White slightly hygroscopic powder

Bi5O (OH)9 (NO3)4

Practically insoluble in water or organic solvents, dissolves readily in a n excess of HCl or HNO3

Pharmaceutical necessity in the preparation of bismuth, astringent, adsorbent, protective in lotions and ointments

Calcium chloride Calcium (II) chloride, calcium dichloride

White, hard odorless fragments or granules, deliquscent

CaCl2 1g in 0.7ml water, 4ml of alcohol

Provides calcium ions in the treatment of hypocalcemic tetany, relieves muscle spasm

Calcium stearate Octadecanoic acid, calcium salt

Fine, white to yellowish white, bulky powder, slight characteristic odor, unctuous and free form grittiness

C36H70CaO4 Insoluble in water, alcohol and ether

Lubricant in the manufacture of compressed tablets, conditioning agent in food and pharmaceutical product

Camphor Bornanone, gum camphor, Laurel camphor, Formosa

Waxy, white or transparent solid with a strong aromatic odor

C10H16O 0,12g in 100ml water, 100g in 100ml chloroform

Slight local anesthetic, plasticizer

Castor oil Emulsoil, Neoloid, Purge

Pale, yellowish or almost odorless, transparent, viscid liquid with faint mild odor and a slightly acrid and nauseating taste

C57H104O9 Soluble in alcohol, miscible with dehydrated alcohol, glacial acetic acid, chloroform or

Internally as laxative and externally as emollient


etherCinnamon oil Cassia oil, oil of

Chinese cinnamonYellowish or brownish, becoming darker and thicker on aging or exposure to the air with the characteristic odor and taste of cassia cinnamon

C9H8O Soluble in equal colume of a;cohol; 2 volumes of 70% alcohol or equal vloulme of glacial acetic acid

Flavorant, formerly was used in a dose of 0.1ml for flatulent colic

Citirc Acid, USP 1,2,3-propanetricarboxlic acid

Colorless, transluscent crystals or a white granular to fine crystalline powder, odorless, strongly acid taste

C6H8O7 1g in 0.5ml water, 2ml of alcohol or about 30ml ether, freely soluble in methanol

Preparation of anticoagulant citrate dextrose solution, citric acid syrup and effervescent salts

Clove oil Oil of Cloves Has a warm, strong, spicy smell and the oil is colorless to pale yellow with a medium to watery viscosity

Insoluble in water, soluble in oils and alcohol

Analgesic, antiseptic, antispasmodic, antineuralgic, anti-infective, disinefectant, insecticide, stimulant, stomachic

Coconut oil Copra oil Pasty solid at room temp but easily melts at a slightly elevated temperature

Insoluble in water at room temp

Saponification, helps in the aborption of fat soluble vitamins in the body

Cornstrach Wheat starch, potato starch

Polygonal, rounded or spheroidal granules up to about 35 micrometer in diameter which is usually have a circular or

Insoluble in cold water or alcohol, soluble in hot water

Adsorbent, demulcent, dusting powder, pharmaceutic aid


several-rayed central cleft

Distilled water Water Colorless, clear liquid without odor and taste

H2O Use as pharmaceuitc aid

Eucalyptus oil Leaf of eucalyptus globulus

Colorless or pale yellow liquid with a characteristic, aromatic, somewhat camphoraceous odor and a pungent, spicy, cooling taste

C10H18O Soluble in 5 volumes of 70% alcohol

Flavoring agent and expectorant in chronic bronchitis; bacteriostatic

FD and C red no.3 Erythrocin, Allura red Red, odorless liquid C20H6I4Na2O5 Soluble in water and alcohol

dye

Ferrous sulfate Iron, Heptahydrtae, Ferri Sulfas, Feosol

Pale, bluish green crystals or granule\s; odorless, has a saline styptic taste and effloresces in dry air, becoming white

FeSO4 1g in 1.5ml of water or 0,5 ml of boiling water, insoluble in alcohol

Commonly employed in hematinic preparations, for iron deficiency anemias

Lye Potassium hydroxide, Caustic potash, Potash lye

White, nearly white, fused masses, small pellets flakes, sticks and other forms; hard and brittle and shows a crystalline fracture

KOH 1g in o.9ml water, 3ml alcohol or 2.5 ml glycerin at 25oC, very soluble in boiling alcohol

caustic

Formaldehyde Solution

Formalin Colorless aqueous solution that officially contains NLT 37%w/v formaldehyde and has a characteristic aroma

HCHO Miscible with water and alcohol

Disinfectant

Gelatin White gelatin Sheets, flakes, shreds or a coarse to fine powder, faintly yellow or amber

Insoluble in cold water, but swells and softens when

Coat tablets and vehicle for suppositories,


in color; slightly characteristic bouillon-like odor

immersed in it emulsifying agent

Glycerin 1,2,3-propanetriol, Glycerol, Opthalgan, Osmoglyn

Clear, colorless, syrupy liquid with a sweet taste and not more than slight, characteristic odor which is neither harsh nor disagreeable when exposed to moist air

C3H8O3 Miscible with water, alcohol or methanol, 1g in about 12 ml ethyl acetate or about 15 ml acetone, insoluble in chloroform, ether, fixed and volatile oils

Humectants, used to reduce corneal edema and to facilitate ophthalmic examination

Isopropyl alcohol 2-propanol, isopropanol, rubbing alcohol

Colorless, flammable chemical compound with a strong odor

C3H7OH Miscible with water

Preservative, solvent, cleaning fluid and a dry-gas fuel additive

Kaolin Kaolin powder USP, clay, hydrated aluminum silicate, china clay, kaolinite

White, odorless, greenish or yellow foliated and earthy

Al2Si2O5(OH)4 Insoluble in water

Production of ceramic, filler for paint, rubber and plastics

Lactose Milk sugar, beta D-galactopyranosyl-(1,4(, beta-D-glucopyranose

White crystalline powder C12H22O11 0.216g in 1ml water, 18.9049g at 25 degree Celsius,

used in infant foods, bakery products, confections, diluents

Lauric acid n-Dodecanoic acid, Dodecyclic acid, Dodecoic acid, laurostearic acid, vulvic acid, 1-undecanecarboxylic acid, duodecyclic acid

White crystalline fatty acid

C12H24O2 Insoluble in water

Antimicrobial, used in making soaps, cosmetics, esters and lauryl alcohol


Lemon oil Lemon peel tincture Yellow to green liquid with lemon odor

C10H18O Insoluble in water

Used in soaps, perfumes and flavors

Light mineral oil Liquid petrolatum, liquid paraffin or white mineral oil

Tasteless, odorless, transparent, colorless, oily liquid

Insoluble in both water and alcohol

Laxatives by lubrication fecal material and intestinal mucosa

Magnesium Carbonate

Magnesite, Barringtonite, Nesequehonite

Very light, odorless white powdery compound existing in anhydrous and hydrated forms

MgCO3 0.0012 mol/L water, 0.375g/100ml

Cosmetics, dusting powder and toothpaste

Magnesium hydroxide

Milk of Magnesia White solid powder that occurs naturally as the mineral brucite

Mg(OH)2 1.2mg/100ml of water

Common component of antacids and laxatives, used in bleaching solutions to whiten clothes

Mannitol Cordycepic aid, manna sugar, D-mannite, Mannogem, Pearlitol

White, odorless, crystalline powder or free-flowing granules

C6H14O6 Practically insoluble in ether

Diluents for lyophilized preparations, sweetening agent

Menthol Hexahydrothymol; 2-isopropyl-5-methylcyclohexanol; 4-isopropyl-1-methylcyclohexan-3-ol; peppermint camphor, racemic menthol

Free-flowing or agglomerated crystalline powder or colorless, prismatic, or a circular shiny crystals or hexagonal or fused masses with a strong characteristic odor and taste

C19H20O Very soluble in 95% ethanol, chloroform, ether, fatty oils and liquid paraffin; soluble in acetone and benzene, very slightly soluble in glycerin,

Flavoring agent


practically insoluble in water

Mineral oil Avatech; Drakeol; heavy mineral oil, heavy liquid petrolatum; liquid petrolatum; paraffin oil; Sirius; white mineral oil

Transparent, colorless, viscous oily liquid without fluorescence in daylight; practically tasteless and odorless when cold and has a faint odor when heated

Practically insoluble in 95% ethanol, glycerin and water; soluble in acetone, benzene, chloroform, carbon disulfide, ether and petroleum ether; miscible with volatile and fixed oils with the exception of castor oil

Emollient, lubricant, oleaginous vehicle, solvent

Palm oil Palm nut oil Dark yellow to yellow red oil of vegetable origin obtained by pressing or boiling the flesh of the fruit of t6he oil palm

C55H96O6 Insoluble in water

Used in the manufacture of soaps, chocolates, cosmetics and candles

Paraffin Hard wax; paraffinum durum; paraffin wax

Odorless and tasteless, translucent, colorless or white solid. Slightly greasy to the touch and may show brittle fracture

C25H52 Soluble in chloroform, ether, volatile oils and most warm foxed oils, slightly soluble in ethanol, practically insoluble in acetone, 95%

Ointment base, stiffening agent


ethanol and waterPeppermint water Pepermint water USP An aqueous based

solution containing peppermint oil

Miscible in water Flavored or sweetened vehicle

Peterolatum Mineral jelly; yellow petrolatum; yellow petroleum jelly

Pale yellow to yellow-colored, translucent, soft, unctuous mass, odorless, tasteless and not more that slightly fluorescent by daylight even when melted

Practically insoluble in acetone, ethanol, hot or cold ethanol, glycerin and water, soluble in benzene, carbon disulfide, chloroform, ether, hexane and most fixed and volatile oils

Emollient, ointment base

Petroleum jelly White petrolatum, white petroleum jelly

White or faintly yellowish, unctuous mass, transparent in thin layers even after cooling to 0 degrees

Insoluble in water, slightly soluble in cold or hot alcohol and in cold dehydrated alcohol, freely soluble in benzene, carbon disulfide and chloroform, soluble in ether, hexane and fixed and volatile oils

Emollient and ointment base

Polyvinylpyrollidone

PNVP, PVP, povidone, polyvidone

White to yellow, hygroscopic, amorphous

(C6H9NO)n Soluble in water and other polar

Binder in pharmaceutical


powder solvents tabletsPotasssium chloride USP

Potassium chloride Odorless, colorless crystals or a white crystalline powder with unpleasant saline taste

KCl Practically insoluble in 95% ethanol

Used in water as a completion fluid in petroleum and natural gas operations and alternative to sodium chloride as water softener

Potassium Hydroxide

Potassium hydroxide White or nearly white fused mass and available in small flakes, pellets, sticks and other shapes of forms

KOH Practically insoluble in glycerin, 1 in 2,5 water

Widely used in pharmaceutical and food industries

Precipitated calcium carbonate

Fine white microcrystalline powder, odorless and tasteless

CaCO3 Poorly soluble in water, insoluble in alcohol

Used in modern paint coatings, ink and paper making materials, aid in antacids

Resorcinol m-dihydroxybenzene White needle shaped crystals or powder

C6H6O2 Soluble in water and alcohol

Used in n1% to 3% solution and in ointments and paste

Rose oil Phenylethyl alcohol USP

A clear liquid C6H5CH2CH2OH Sparingly soluble in water

Used primarily in perfumery

Saccharin Odorless, white crystals or a white crystalline powder with intensely sweet taste with a metallic aftertaste

C7H5NO3S Not water soluble Sweetening agent

Sodium benzoate White granular or C7H5NaO2 Antimicrobial


crystalline hygroscopic powder. Odorless or with a faint odor of benzoin and has unpleasant sweet and saline taste

preservative in cosmetics, food and pharmaceuticals

Sodium bicarbonate Monosodium salt, baking soda, Na acid carbonate

White crystalline, odorless and with a saline and slightly alkaline taste powder

NaHCO3 1g in 12ml water, insoluble in alcohol

Gastric antacid, urinary alkalinizer

Sodium borate Borax, Na tetraborate, Na pyroborate, Na biborate

Colorless, transparent crystals or a white crystalline, odorless powder

Na2B4O7.10H20 1g in 16ml water, 1ml glycerin, 1ml boiling water, insoluble in alcohol

Pharmaceutical necessity, alkalizing agent, buffer in denture adhesives

Sodium chloride Common salt, halite, table salt, rock salt

Colorless, cubic crystals or a white crystalline, odorless with a saline taste powder

NaCl 1g in 2.8ml water, 10ml glycerin, 2.7ml boiling water, slightly soluble in alcohol

Electrolyte replenisher, replacement of pH deficits

Sodium citrate 1-2-3 propane tricarboxylic acid; 2 hydroxy-trisodium salt

Colorless crystals or a white crystalline powder with a cooling saline taste

C6H5Na3O7 1g in 1.5ml water at 265 degree Celsius or 0.6ml boiling water, insoluble in alcohol

Expectorant, systemic and urine alkalinizer

Spermaceti Cetyl ester wax White to off-white somewhat translucent flakes with faint odor and with a bland mild taste

Insoluble in water; practically insoluble on cold alcohol; soluble in boiling alcohol, ether, chloroform,

Pharmaceutic aid in ointments


carbon disulfideStearic acid Octadecanoic acid,

cetyl acetic acid, stearophanic acid

Hard, white or faintly yellowish somewhat glossy and crystalline solid or a white yellowish powder with a tallow odor and taste

C18H36O2 Practically insoluble in water, 1g in 20ml alcohol, 2ml chloroform, 3ml ether, 25ml acetone or 60ml carbon tetrachloride; freely soluble in carbon disulfide; soluble in amyl acetate benzene and toluene

Solidifying agent

Sucrose 2-D glucopyuranoside-sugar, cane sugar, beet sugar

Colorless or white crystals, odorless, sweet taste powder or crystals

C13H22O11 1g in 0.5ml water, 120ml alcohol; insoluble in chloroform or ether

Pharmaceutic necessity

Sulfadiazine 40amino-N-pyrimidin-2-yl-benzenesulfonamide

White or slightly yellow powder, odorless

C10H10N4O2S 1g in 3,000ml water; sparingly soluble in alcohol; 1g in 60ml human serum; freely soluble in dilute mineral acids

antibacterial

Sulfamerazine 2-sulfanilamido-4-methylpyrimidine

White or faintly yellowish white crystals or powder, has a lightly bitter taste and is odorless or practically so

C11H12N4O2S Very slightly soluble in water; sparingly soluble in acetone; slightly soluble in

antibacterial


it is stable in air but slowly darkness on exposure to light

ether and chloroform

Sulfamethezine Sulfamithiazine, Sulfisomidine, Primazin, Primazin

White to yellowish white powder which may darken on exposure to light and has a slightly bitter taste and is almost odorless

C12H14N4O2S Very soluble in water and alcohol

A ntibacterial

Sweet almond oil Colorless, odorless, lubricating, light, sweet and nutty aroma, absolutely clear in color with a tinge of yellow

Relieve skin itch and dryness

Syrup, USP Simple syrup, Sirup Contains 85% sucrose in water

1g in 0.5ml of water

Sweetening agent and a base for many flavored and medicated syrup

Talc Talcum, purified talc, French salt, soapstone

A very fine, white grayish white crystalline powder, unctuous to the touch, adhering readily to the skin and free from grittiness

H2Mg3(SiO3)4 Relieve skin itch and dryness

triethanolamine A viscous, hygroscopic liquid with an ammonia aroma; colorless to pale yellow aqueous solution

(HOCH2CH2)3N Soluble in chloroform, water and alcohol

Used in dry cleaning soaps, cosmetics, household detergents and textile processing

Turpentine oil Pinene isomers Clear liquid C10H16 Miscible with Used chiefly in


mixture, Spirits of Turpentine Terpene; Dipanol; Kautschin; Oil of Turpentine

absolute alcohol and ether

paints, vanishes and waxes

Veegum Magnesium aluminum silicate

Stabilize emulsion and suspension

White wax Bleached beeswax, white beeswax, bleached wax

Yellowish white, nearly tasteless, somewhat translucent, solid with a faint characteristic odor

Insoluble in water, soluble in cold alcohol, completely soluble in chloroform, ether, fixed and volatile oils

Stiffening agent in cerates, pastes and ointment

Yellow wax Beeswax and yellow beeswax

Yellow to grayish brown solid with an disagreeable, honey like odor and a faint characteristic taste

Stiffening agent

Zinc chloride White or nearly white, odorless, crystalline powder or as porcelain like masses or in molded pencils

ZnCl 1g in 0.5ml water, 1.5ml alcohol and 2ml glycerin

Caustic in high concentration, astringent in low concentration and mildly6 antibacterial

Zinc oxide Very fine, odorless, amorphous, white or yellowish white powder that is free form grittiness

ZnO Insoluble in water and alcohol but soluble in diluted acids

Mild astringent, protective and antiseptic, employed in the treatment of skin disease and infections


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Manufacturing Excipients