Manufacturing Excipients
-
Upload
harlene-de-guzman-patayan -
Category
Documents
-
view
98 -
download
2
Transcript of 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
MANUFACTURING EXCIPIENTS
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
MANUFACTURING EXCIPIENTS
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
MANUFACTURING EXCIPIENTS
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
MANUFACTURING EXCIPIENTS
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,
MANUFACTURING EXCIPIENTS
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
MANUFACTURING EXCIPIENTS
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
MANUFACTURING EXCIPIENTS
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
MANUFACTURING EXCIPIENTS
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
MANUFACTURING EXCIPIENTS
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
MANUFACTURING EXCIPIENTS
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
MANUFACTURING EXCIPIENTS
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
MANUFACTURING EXCIPIENTS
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
MANUFACTURING EXCIPIENTS
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
MANUFACTURING EXCIPIENTS