Remington: The
`Science and Practice
`
`of Pharmacy
`
`Volume II
`
`Petitioner |nnoPharma EX 1106
`
`|PR2015-00902
`
`|PR2015-00903
`
`Page 1
`
`

`
`EDITEON
`
`
`
`ALFQNSO R GENNARO
`
`Chairman of the Editorial Board
`and Editor
`
`Page 2
`
`Page 2
`
`

`
`1995
`
`MACK PUBLISHING COMPANY
`Eastern, Pennsylvania 18042
`
`
`
`Page 3
`
`

`
`CH2 oAc
`
`Butanedioic acid, [R-(R*,R*)] 2,3-dihydroxy-,
`
`PHARMACEUTICAL NECESS|T|ES
`
`1415
`
`Uses——Ofl"rcially, as a dusting powder and pharmaceutic aid; in both
`categories it has many specific uses.
`Its medicinal use as a dusting
`powder depends on its desiccant and lubricant effects. Vlflien perfumed,
`and sometimes medicated, it is used extensively for toilet purposes under
`the name talcum powder; for such Lise it should be in the form of an
`impalpable powder. When used as a filtration medium for clarifying
`liquids a coarser powder is preferred to minimize passage through the
`pores of the filter paper; for this purpose it may be used for all classes of
`preparations with no danger of adsorption or retention of active principles.
`It is used as a lubricant in the manufacture of tablets, and as a dusting
`powder when making handmade suppositories. Although it is used as a
`lubricant for putting on and removing rubber gloves, it should not be used
`on surgical gloves because even small amounts deposited in organs or
`healing wounds may cause granuloma formation.
`Tartaric Acid
`
`COOH
`
`H -~ C-- OH
`H0—C-H
`COOH
`
`L—(+)—Tartaric acid [87-69-4] C4H5O5 (150.09).
`Preparation——From ctrgol, the crude cream of tartar (potassium bitar—
`trate) deposited on the sides of wine casks during the fermentation of
`grapes, by conversion to calcium tartrate which is hydrolyzed to tartaric
`acid and calcium sulfate.
`V
`Description-——Large, colorless or translucent crystals, or awhite granu-
`lar to fine crystalline powder; odorless; acid taste; stable in the air; solu-
`tions acid to litmus; dextrorotatory.
`Solubility——l g in 0.8 mL water, 0.5 mL boiling water, 8 rnL alcohol or
`250 mL ether;-freely soluble in methanol.
`Uses——Chiefly, as the acid ingredient of preparations in which it is
`neutralized by a bicarbonate, as in effervescent salts, and the free acid is
`completely absent or present only in small amounts in the finished product.
`It also is used as a buffering agent.
`
`Trichloromonofluoromethane
`
`Methane, trichlorofluoro-,
`CFCI3
`
`Trichlorofluoromethane [75-69-4] CCISF (137.37).
`Preparation——Carbon tetrachloride is reacted with antimony trifluo-
`ride in the presence of a small quantity of antimony pentachloride. The
`reaction produces a mixture of CCl3F and CCl2F2 which is readily sepa-
`rable by fractional distillation.
`Description-«Clear, colorless gas; faint, ethereal odor; vapor pressure
`at 25° is about 796 torr; boils about 24°.
`Solubility——Practlcal1y insoluble in water; soluble in alcohol, other or
`other organic solvents.
`Uses—Apropellant (No l 1, see page 1696).
`
`Tyloxapol
`
`Phenol, 4-(1,l,3,3-tetramethylbutyl)-, polymer with formaldehyde
`and oxirane; (Various Mf7‘s)
`
`OR
`
`OR
`
`OR
`
`ZnSO4 + KZS3 6 z_r§ + 2s + K2804
`Talc
`
`or or to
`
`CaHn
`
`COHI7
`
`CaHi7
`
`Talcum; Purified Talc; Wench Chalk; Soapstone; Steatite
`
`[R is CHZCHZO(CH2CH2O)mCH2CH2OH;
`m is 6 to 8; n is not more than 5]
`
`A native, hydrous magnesium silicate, sometimes containing a small
`proportion of aluminum silicate.
`Occurrence and Preparation—The native form, called soapstone or
`‘F‘*"ench chalk, is found in various parts of the world. An excellent quality
`15 Obtained from deposits in North Carolina. Deposits of a high grade,
`Conforming to the USP requirements, also are found in Manchuria. The
`n*‘tiVe form usually is accompanied by variable amounts of mineral
`flubstances. These are separated from it by mechanical means, such as
`Ptation or elutriation.
`It then is powdered finely, treated with boiling
`‘mute HCl, washed well and dried.
`‘
`DEScription—Very fine, white, or grayish white crystalline powder;
`ss.
`Elelctuous to the touch, adhering readily to the skin, and free from gritti-
`
`p-(1,1,3,3-Tetramethylbutyl)phenol polymer with ethylene oxide and
`formaldehyde [2530]-02-4].
`Pre'paration—p-(1 ,1 ,3 ,3-Tetramethylbutyl)phenol and formaldehyde
`are condensed by heating in the presence of an acidic catalyst and the
`polymeric phenol thus obtained is reacted with ethylene oxide at elevated
`temperature under pressure in the presence of NaOH. US Pat. 2,454,541.
`Description—Amber, viscous liquid; may show a slight turbidity; slight
`aromatic odor; specific gravity about 1.072; stable at sterilization tempera-
`ture and in the presence of acids, bases and salts; oxidized by metals; pH
`(5% aqueous solution) 4 to 7.
`
`
`
`Page 4
`
`
`‘N
`
`so11A1bi1ity—-Insoluble in water, but soluble, usually incompletely, in an
`equal weight ofwarm alcohol; soluble in acetone, carbon disulfide or ether,
`some insoluble residue usually remaining.
`Uses~An expectoram but is used chiefly as a local remedy, especially
`in combination with benzoin; eg, it is an ingredient of Compormd Benzoin
`T,-,,wLu7'e (page 869).
`It may be used, like benzoin,
`to protect fatty
`Substances from rancidity.
`Sucrose Octaacetate
`
`a.p—Glucopyranoside, 1,3,4,6—tetra-O-acetyl-B-D-fructofuranosyl—,
`tetraacetate
`
`cuzom;
`o ACOCHZ 0
`AcO
`
`OAc
`
`0
`
`AC0
`
`OAc
`
`OAC
`
`9
`(Ac is Cl-l3C—)
`
`_
`
`-
`
`Sucrose octaacetate [126—l4-7] C23H33O,9 (678.60).
`Pr-eparation——Sucrose is subjected to exhaustive acetylation by reac~
`tion with acetic anhydride in the presence of a suitable condensing agent
`such as pyridine.
`Description~—White, practically odorless powder; intensely bitter taste;
`hygroscopic; melts not lower than 78°.
`Solubi1ity——l g in M00 mL water, 11 mL alcohol, 0.3 mL acetone or
`0.6 mL benzene; very soluble in methanol or chloroform; soluble in ether.
`Uses——A denaturant for alcohol.
`
`Sulfurated Potash
`
`Thiosulfuric acid, dipotassium salt, mixt. with potassium sulfide
`(K2(S_-5)); Liver of Sulfur
`
`Dipotassium thiosulfate mixture with potassium sulfide (K233) [39365-
`88-3]; a mixture composed chiefly of potassium polysulfides and potas-
`sium thiosulfate.
`It contains not less than 12.8% of S (sulfur) in combina-
`tion as sulfide.
`Prepai-ation~—By thoroughly mixing 1 part of sublimed sulfur with 2
`parts of potassium carbonate and gradually heating the mixture.
`in a
`covered iron crucible until the mass ceases to swell and is melted
`completely.
`It then is poured on a stone or glass slab and, when cold,
`broken into pieces and preserved in tightly closed bottles. When the heat
`is regulated properly during its production, the reaction is represented
`approximately by
`
`SKZCO3 + 8S ~> 2K2S3 + K2S2O3 + 3CO2
`
`As this product rapidly deteriorates on exposure to moisture, oxygen
`and carbon dioxide, it is important that it be prepared recently to produce
`satisfactmy preparations.
`'
`Description—lrregular pieces,
`liver—brown when freshly prepared,
`changing to a greenish yellow; decomposes upon exposure to air; an odor
`Of hydrogen sulfide and a bitter, acrid, alkaline taste; even weak acids
`Cause the liberation of H25 from sulfurated potash; 1 in 10 solution light
`b1‘0Wn in color and alkaline to litmus.
`So1ubility——l gin about 2 mL water, usually leaving a slight residue;
`alcohol dissolves only the sulfides.
`Uses—Extensively in dermatological practice, especially in the official
`White Lotion or LotioAlba (page 873).
`It is used as an opacifier.
`1 The equation for the reaction ofthe potassium trisulfide in preparing the
`otion is
`
`
`
`Page 4
`
`

`
`1416
`
`CHAPTER so
`
`_Solubility—Slowly but freely soluble in water; soluble in many organic
`solvents, including acetic acid, benzene, carbon tetrachloride, carbon
`disulfide, chloroform or toluene.
`Uses——A nonionic detergent that depresses both surface tension and
`interfacial tension.
`It also is used in contact—lens-cleaner formulations.
`Zinc-Eugenol Cement——see RPS—18, page 1328.
`
`lso-Alcoholic Elixir
`
`Iso-Elixir
`
`Low-Alcoholic Elixir
`High-Alcoholic Elixir . .
`Mix the ingredients.
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`of each a calculated volume
`
`Low-Alcoholic Elixir
`Compound Orange Spirit.
`Alcohol .
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`Glycerin ..
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`. .. 200 mL
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`Sucrose .
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`. .. 320 g
`Purified Water, a suflicient quantity,
`To make .
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`Alcohol Content———8 to 10%.
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`. .. 1000 ml.
`
`High-Alcoholic Elixir
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`4 mL
`.
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`Compound Orange Spirit.
`
`3 g
`..
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`Saccharin .
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`. .;. 200 mL
`. . .
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`Glycerin . .
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`‘
`V
`g
`Alcohol, a sufficient quantity,
`To make ............................................... .. 1000 mL
`Alcohol Content—78 to 78%.
`Uses—lntended as a general vehicle for various medicaments that
`require solvents of different alcohol strengths. When it is specified in a
`prescription, the proportion of its two ingredients to be used is that which
`will produce a solution of the required alcohol strength.
`The alcohol strength of the elixir to be used with a single liquid galenical
`in a prescription is approximately the same as that ofthe galenical. When
`galenicals of different alcohol strengths are used in the same prescription,
`the elixir to be used is to be of such alcohol strength as to secure the best
`solution possible. This generally will be found to be the average of the
`alcohol strengths of the several ingredients.
`For nonextractive substances, the lowest alcohol strength of the elixir
`that will yield a perfect solution should be chosen.
`
`Other Miscellaneous Pharmaceutical Necessities ’
`Bucrylate [Propenoic acid, 2—cyano-, 2-methylpropyl ester; lsobutyl
`2-cyanoacrylate [1069-55-2] CgH, JNO2 (153.18); (Ethic0n)]-—-Prepara-
`lion: One method reacts isobutyl 2-chloroacrylate with sodium cyanide.
`Uses: Surgical aid (tissue adhesive).
`Ceresin [Ozokerite; Earth Wax; Cerosin; Mineral Wax; Fossil Wax]——A
`hard, white odorless solid resembling spermaceti when purifiedfdcicurring
`naturally in deposits in the Carpathian Mountains, especially in Galicia.
`It is a mixture of natural complex paraffin hydrocarbons. Melts between
`61 and 78°; specific gravity 0.91 to 0.92; stable toward oxidizing agents.
`Soluble in 30% alcohol, benzene, chloroform, petroleum, benzin or hot
`oils. Uses: Substitute for beeswax; in dentistry, for impression waxes.
`Ethylenediamine Hydrate BP, Phl [H2NCH2CH2NH2.H2O]——Clear,
`colorless or slightly yellow liquid with an ammoniacal odor and character-
`istic alkaline taste; solidifies on cooling to a crystalline mass (mp 10°);
`boils 118 to ll9°; specific gravity about 0.96; hygroscopic and absorbs
`CO2 from the air; aqueous solutions alkaline to litmus. Miscible with
`water or alcohol; soluble in 130 parts of chloroform; slightly soluble in
`benzene or ether. Uses:
`In the manufacture of aminophylline and in the
`preparation of aminophylline injections. See Ethylenediamine (page
`1381).
`It is made by
`Ferric Oxide, Red——Contains not less than 90% Fe2O3.
`heating native ferric oxide or hydroxide at a temperature which will yield a
`product of the desired color. The color is governed by the temperature
`and time of heating, the presence and kind of other metals and the particle
`size ofthe oxide. A dark-colored oxide is favored by prolonged heating at
`high temperature and the presence of manganese. A light-colored oxide
`is favored by the presence of aluminum and by finer particle size. Uses:
`Imparting color to neocalamine and cosmetics.
`It is
`Ferric Oxide, Yellow——Contains not less than 97.5% Fe2O3.
`prepared by heating ferrous hydroxide or ferrous carbonate in air at a low
`temperature. Uses: As forRed Ferric Oxide (above).
`,
`Honey NF XII [Me1; Clarified Honey; Strained Honey]—-—The saccha-
`rine secretion deposited in the honeycomb by the bee, Apis mellifera
`
`Lime [Calx; Calcium Oxide; Quicklime; Burnt Lime; Calx Usta; CaO
`(56.08) ]——Preparation: By calcining limestone (a native calcium car-
`bonate) in kilns with strong heat. Description and Solubility: Hard,
`white or grayish white masses or granules, or a white or grayish white
`powder; odorless; solution strongly alkaline.
`l g is soluble in about 840
`mL water and 1740 mL boiling water; soluble in glycerin or syrup; in-
`soluble in alcohol. Uses:
`In making mortar, whitewash, and various
`chemicals and products.
`It is an ingredient in Sulfurated Lime Solution
`(RPS-1 6, page 1187).
`In the USP, calcium hydroxide has replaced it, as it
`is more stable and more readily available of a quality suitable for medicinal
`use than the lime usually obtainable. Unless protected from air, lime
`soon becomes unfit for use, due to the action of carbon dioxide and
`moisture in the air. See C'alciumHyd7‘oxide (page 1408).
`.
`Peach Oil-—An oil resembling almond oil obtained from Persica vul-
`garis (Famftosaceae). See Persic Oil (RPS—18, page 1323).
`Polacrilin Potassium [Methacrylic acid polymer with divinylbenzene,
`potassium salt [39394—76-5]; Arnberlite IRP-88 (Rohm & Haas) ]—
`Prepared by polymerizing methacrylic acid with divinylbenzene and the
`resulting resin is neutralized with KOH.
`Dry, buff-colored, odorless,
`tasteless, free-flowing powder; stable in light, air, and heat; insoluble in
`water. Uses: Phawnaceutic aid (tablet disintegrant).
`Poloxalene [Glyc0ls, polymers, polyethyleneépolypropylene [9003-l l-
`6]——Polypropylene glycol
`is reacted with ethylene oxide. Uses:
`Phaimaceutic aid (surfactant).
`2
`Raspberry Juice—The liquid expressed from the fresh ripe fruit of
`Rubus idaeus Linné or of Rubus strigosus Michaux (Fam Rosaceae);
`contains not
`less
`than
`1.5% of
`acids
`calculated as
`citric
`acid. Preparation: Express the juice from the washed, well—drained,
`fresh, ripe, red raspberries. Dissolve 0.1% of benzoic acid in the ex-
`pressed juice and allow it to stand at room temperature (possibly for
`several days) until a small portion of the filtered juice produces a clear
`solution when mixed with 1/2 of its volume of alcohol, the solution remain~
`ing clear for not less than 30 min. Strain the juice from the mixture or
`filter it, if necessary. Description: Clear liquid with an aromatic, char~
`acteristic odor and a characteristic, sour taste; the freshly preparedjuice is
`red to reddish orange; affected by light.
`Uses:
`In the preparation of
`Raspberry Syrup (see RPS-18, page 1302), aflavored vehicle.
`Sodium Glutamate
`[Sodium Acid Glutamate
`[142-47-2]
`HOOCCH(NH2)CH2CH2COONa]——W'hite or nearly white, crystalline
`powder. Very soluble in water; sparingly soluble in alcohol. Uses.‘
`Imparts a meat flavor to foods.
`Sodium Thioglycollate [Sodium Mercaptoacetate; HSCH2CO0Na]~
`Hygroscopic crystals which discolor on exposure to air or iron. Freely
`soluble in water; slightly soluble in alcohol. Uses: Reducing agent in
`Fluid Thioglycollate Medium for sterility testing.
`Suet, Prepared [Mutton Suet]——Internal fat of the abdomen of the
`sheep, Ovis aries (Fam Bovidae), purified by melting and straining-
`White, solid fat with a slight, characteristic odor and taste when fresh;
`melts between 45° and 50° and congeals between 37° and 40°; must be
`cerates.
`preserved in a cool place in tight containers. Uses:
`In ointments and
`
`Urea [Carbamide [57-13-6} CO(NH2)2(60.O6)]———A product of protein
`metabolism; prepared by hydrolysis of cyanamide or from carbon dioxide
`by ammonolysis. Colorless to white crystals or white, crystalline powder;
`almost odorless but may develop a slight odor of ammonia in presence Of
`moisture; melts 132 to 185°.
`1 g dissolves in 1.5 mL of water or 10 mL of
`alcohol; practically insoluble in chloroform or ether. Uses: A protein
`denaturant that promotes hydration of keratin and mild keratolysis in dly
`and hyperkeratotic skin.
`It is used in 2 to 20% concentrations in various
`dry-skin creams.
`
`Page 5
`
`It must be free from foreign substances such as
`Linné (Fam Apidae).
`parts of insects, leaves, etc, but may contain pollen grains. History.
`Honey is one of the oldest of food and medicinal products. During the
`16th and 17th centuries it was recommended as a cure for almost
`everything. Constituents:
`Invert sugar (62 to 83%), sucrose (0 to 3%)
`and dextrin (0.26 to 7%). Description: Thick, syrupy liquid of a light
`yellowish to reddish brown color; translucent when fresh, but frequently
`becomes opaque and granular through crystallization of dextrose; charac.
`teristic odor and a sweet, faintly acrid taste. Uses: A sweetening agent
`and pharmaceutic necessity.
`Hydriodic Acid, Diluted——Contains, in each 100 mL 9.5 to 10.5 g ofm
`(127.91), and 600 mg to 1 g of HPHZOZ (66.00). The latter is added to
`preventthe formation offreeiodine. Caution: DiluledHydri0dicAcid
`must not be dispensed or used in the preparation ofother products if
`they containfree iodine. Preparation: On a large scale, by the inter.
`action of iodine and hydrogen sulfide. Description and Solubility;
`Colorless or not more than pale-yellow, odorless liquid; specific gravity
`about 1.1.. Miscible with water or alcohol. Uses:
`in Hydriodic Acid
`Syrup (page 1893). The latter has been used as an expectorant.
`It also
`is used in the manufacture of inorganic iodides and disinfectants,
`The 57% acid also is used for analytical purposes, such as methoxyl
`determinations.
`
`‘u'u“O-1-1-s
`
`
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`Page 5