20 TH EDITION
`
`Remington: The
`sc;· ence and
`Practice
`of Pharmacy
`
`ALFONSO R GENNARO
`Chairman of the Editorial Board
`
`and Editor
`
`Metrics EX1027, Page 1
`
`

`

`t
`\
`
`Editor: Daniel Limmer
`Managing Editor: Matthew J. Hauber
`Marketing Manager: Anne Smith
`
`Lippincott Williams & Wilkins
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`by any information storage and retrieval system without written permission
`from the copyright owner.
`
`The publisher is not responsible (as a matter of product liability, negligence or
`otherwise) for any injury resulting from any material contained herein. This
`publication contains information relating to general principles of medical care
`which should not be construed as specific instructions for individual patients.
`Manufacturers' product information and package inserts should be reviewed for
`current information, including contraindications, dosages and precautions.
`
`Printed in the United States of America
`
`Entered according to Act of Congress, in the year 1885 by Joseph P Remington,
`in the Office of the Librarian of Congress, at Washington DC
`
`Copyright 1889, 1894, 1905, 1907, 1917, by Joseph P Remington
`
`Copyright 1926, 1936, by the Joseph P Remington Estate
`
`Copyright 1948, 1951, by the Philadelphia College of Pharmacy and Science
`
`Copyright 1956, 1960, 1965, 1970, 1975, 1980, 1985, 1990, 1995, by the Phila(cid:173)
`delphia College of Pharmacy and Science
`
`Copyright 2000, by the University of the Sciences in Philadelphia
`
`All Rights Reserved
`Library of Congress Catalog Card Information is available
`ISBN 0-683-3064 72
`
`The publishers have made every effort to trace the copyright holders for borrowed
`material. If they have inadvertently overlooked any, they will be pleased to make
`the necessary arrangements at the first opportunity.
`
`The use of structural formulas from USAN and the USP Dictionary of Drug
`Names is by permission of The USP Convention. The Convention is not respon(cid:173)
`sible for any inaccuracy contained herein.
`Notice-This text is not intended to represent, nor shall it be interpreted to be, the
`equivalent of or a substitute for the official United States Pharmacopeia (USP)
`and/or the National Formulary (NF). In the event of any difference or discrep(cid:173)
`ancy between the current official USP or NF standards of strength, quality,
`purity, packaging and labeling for drugs and representations of them herein, the
`context and effect of the official compendia shall prevail.
`
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`Metrics EX1027, Page 2
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`congeals at a temperature not lower than 15.6°, corresponding to a
`minimum of 99.4% of CH3COOH; specific gravity about 1.05.
`Solubility-Miscible with water, alcohol, acetone, ether, or glyc(cid:173)
`erin; insoluble in carbon tetrachloride or chloroform.
`Uses-A caustic and vesicant when applied externally and is often
`sold under various disguises as a corn solvent. It is an excellent solvent
`for fixed and volatile oils and many other organic compounds. It is used
`primarily as an acidifying agent.
`ALUMINUM
`Aluminum AI (26.98); the free metal in the form of finely divided
`powder. It may contain oleic acid or stearic acid as a lubricant. It
`contains not less than 95% AI and not more than 5% Acid-insoluble
`substances, including any added fatty acid.
`Description-Very fine, free-flowing, silvery powder free from
`gritty or discolored particles.
`Solubility-Insoluble in water or alcohol; soluble in hydrochloric
`and sulfuric acids or in solutions of fixed alkali hydroxides.
`Uses-A protective. An ingredient in Aluminum Paste.
`ALUMINUM MONOSTEARATE
`
`Aluminum, dihydroxy(octadecanoato-0-)-,
`Dihydroxy(stearato)aluminum [7047-84-9]; a compound of aluminum
`with a mixture of solid organic acids obtained from fats, and consists
`chiefly of variable proportions of aluminum monostearate and alumi(cid:173)
`num monopalmitate.lt contains the equivalent of 14.5 to 16.5% of Al20 3
`(101.96).
`Preparation-By interaction of a hydroalcoholic solution of potas(cid:173)
`sium stearate with an aqueous solution of potassium alum, the precip(cid:173)
`itate being purified to remove free stearic acid and some aluminum
`distearate simultaneously produced.
`Description-Fine, white to yellowish white, bulky powder; faint,
`characteristic odor.
`Solubility-Insoluble in water, alcohol, or ether.
`Uses-A pharmaceutical necessity used in the preparation of Sterile
`Procaine Penicillin G with Aluminum Stearate Suspension.
`STRONG AMMONIA SOLUTION
`
`Stronger Ammonia Water; Stronger Ammonium Hydroxide
`Solution; Spirit of Hartshorn
`Ammonia [1336-21-6]; a solution of NH3 (17.03), containing 27.0 to
`31.0% (w/w) ofNH3 . Upon exposure to air it loses ammonia rapidly.
`Caution-Use care in handling it because of the caustic nature of the
`Solution and the irritating properties of its vapor. Cool the container
`well before opening, and cover the closure with a cloth or similar mate(cid:173)
`rial while opening. Do not taste it, and avoid inhalation of its vapor.
`Preparation-Ammonia is obtained commercially chiefly by syn(cid:173)
`thesis from its constituent elements, nitrogen and hydrogen, combined
`under high pressure and at high temperature in the presence of a
`catalyst.
`Description-Colorless, transparent liquid; exceedingly pungent,
`characteristic odor; even when well diluted it is strongly alkaline to
`litmus; specific gravity about 0.90.
`Solubility-Miscible with alcohol.
`Uses-Only for chemical and pharmaceutical purposes. It is used
`primarily in making ammonia water by dilution and as a chemical
`reagent. It is too strong for internal administration. It is an ingredient
`in Aromatic Ammonia Spirit.
`BISMUTH SUBNITRATE
`
`Basic Bismuth Nitrate; Bismuth Oxynitrate; Spanish White;
`Bismuth Paint; Bismuthyl Nitrate
`Bismuth hydroxide nitrate oxide
`[1304-85-4] Bi50 (0H)9(N03 )4
`(1461.99); a basic salt that, dried at 105° for 2 hr, yields upon ignition
`not less than 79% ofBi20 3 (465.96).
`Preparation-A solution of bismuth nitrate is added to boiling
`water to produce the subnitrate by hydrolysis.
`Description-White, slightly hygroscopic powder; suspension in
`distilled water is faintly acid to litmus (pH about 5).
`Solubility-Practically insoluble in water or organic solvents; dis(cid:173)
`solves readily in an excess of hydrochloric or nitric acid.
`Incompatibilities-Slowly hydrolyzed in water with liberation of
`nitric acid; thus, it possesses the incompatibilities ofthe acid. Reducing
`agents darken it with the production of metallic bismuth.
`Uses-A pharmaceutical necessity in the preparation of milk of
`bismuth. It also is used as an astringent, adsorbent, and protective;
`however, its value as a protective is questionable. This agent, like other
`insoluble bismuth salts, is used topically in lotions and ointments.
`
`PHARMACEUTICAL NECESSITIES
`
`1041
`
`BORIC ACID
`Boric Acid (H 3 B03); Boracic Acid; Orthoboric Acid
`Boric acid [10043-35-3] H3B03 (61.83).
`Preparation-Lagoons of the volcanic districts of Tuscany for(cid:173)
`merly furnished the greater part of this acid and borax of commerce.
`Borax is now found native in California and some of the other western
`states; calcium and magnesium borates are found there also. It is
`produced from native borax or from the other borates by reacting with
`hydrochloric or sulfuric acid.
`De scription-Colorless scales of a somewhat pearly luster, or crys(cid:173)
`tals, but more commonly a white powder slightly unctuous to the touch;
`odorless and stable in the air; volatilizes with steam.
`Solubility-
`! gin 18 mL water, 18 mL alcohol, 4 mL glycerin, 4 mL
`boiling water, or 6 mL boiling alcohol.
`Uses-A buffer, and it is this use that is recognized officially. It is a
`very weak germ~cide aocal anti-infective). Its nonirritat1ng properties
`make its solutions suitable for application to such delicate structures as
`the cornea of the eye. Aqueous solutions are employed as an eye wash,
`mouth wash, and for irrigation of the bladder. A 2.2% solution is
`isotonic with l acrimal fluid. Solutions, even if they are made isotonic,
`will hemolyze red blood cells. It also is employed as a dusting powder,
`when diluted with some inert material. It can be absorbed through
`irritated skin, eg, infants with diaper rash.
`Although it is not absorbed significantly from intact skin, it is
`absorbed from damaged skin and fatal poisoning, particularly in in(cid:173)
`fants, has occurred with topical application to burns, denuded areas,
`granulation tissue, and serous cavities. Serious poisoning can result
`from oral ingestion of as little as 5 g. Symptoms of poisoning are nausea,
`vomiting, abdominal pain, diarrhea, headache, and visual disturbance.
`Toxic alopecia has been reported from the chronic ingestion of a mouth
`wash containing it. The kidney may be injured, and death may result.
`Its use as a preservative in beverages and foods is prohibited by na(cid:173)
`tional and state legislation. There is always present the danger of
`confusing it with dextrose when compounding milk formulas for infants.
`Fatal accidents have occurred. For this reason boric acid in bulk is
`colored, so that it cannot be confused with dextrose.
`It is used to prevent discoloration of physostigmine solutions.
`CALCIUM HYDROXIDE
`Slaked Lime; Calcium Hydrate
`Calcium hydroxide [1305-62-0] Ca(OH)z (74.09).
`Preparation-By reacting freshly prepared calcium oxide with
`water.
`Description-White powder; alkaline, slightly bitter taste; absorbs
`carbon dioxide from the air, forming calcium carbonate; solutions ex(cid:173)
`hibit a strong alkaline reaction.
`Solubility-! gin 630 mL water or 1300 mL boiling water; soluble
`in glycerin or syrup; insoluble in alcohol; the solubility in water is
`decreased by the presence of fixed alkali hydroxides.
`Uses-In the preparation of Calcium Hydroxide Solution.
`CALCIUM HYDROXIDE TOPICAL SOLUTION
`Calcium Hydroxide Solution; Lime Water
`A solution containing, in each 100 mL, not less than 140 mg of Ca(OH)2
`(74.09).
`Note-The solubility of calcium hydroxide varies with the tempera(cid:173)
`ture at which the solution is stored, being about 170 mg/100 mL at 15°
`and less at a higher temperature. The official concentration is based
`upon a temperature of 25°.
`·
`Preparation-
`Calcium Hydroxide .............. . .... ... ...... ................ ..
`Purified Water .... .. .. _ .. . . .......... .......... .. .. .. ....... .... .
`
`3g
`1000 mL
`
`Add the calcium hydroxide to 1000 mL of cool, purified water, and
`agitate the mixture vigorously and repeatedly during 1 hr. Allow the
`excess calcium hydroxide to settle. Dispense only the clear, supernatant
`liquid.
`The undissolved portion of the mixture is not suitable for preparing
`additional quantities of the solution.
`The object of keeping lime water over undissolved calcium hydroxide
`is to ensure a saturated solution.
`Description-Clear, colorless liquid; alkaline taste; strong alkaline
`reaction; absorbs carbon dioxide from the air, a film of calcium carbon(cid:173)
`ate forming on the surface of the liquid; when heated, it becomes turbid,
`owing to the separ ation of calcium hydroxide, which is less soluble in
`hot than in cold water.
`Uses-Too dilute to be effective as a gastric antacid. It is employed
`topically as a protective in various types of lotions. In some lotion
`formulations it is used with olive oil or oleic acid to form calcium oleate,
`
`,.
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`Metrics EX1027, Page 3
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