Handbook of
`Pharmaceutical Exc pients
`
`FIFTH EDITION
`
`Edited by
`
`Raymond C Rowe
`BPharm, PhD, DSc, FRPharmS, CChem,
`
`FRSC, CPhys, MInstP
`
`Chief Scientist
`
`Intelligensys Ltd
`
`Billingham, UK
`
`Paul J Sheskey
`BSc, RPh
`
`Technical Services Leader
`
`The Dow Chemical Company
`
`Midland
`
`MI, USA
`
`Skin C Owen
`BSc, MA
`
`Development Editor
`
`Royal Pharmaceutical Society of Great Britain
`
`London, UK
`
`APhA
`
`(PP)
`
`Pharmaceutical Press
`
`London • Chicago (cid:9)
`
`Mylan Ex 1045, Page 1
`
`

`

`Published by the Pharmaceutical Press
`Publications division of the Royal Pharmaceutical Society of Great Britain
`
`1 Lambeth High Street, London SE1 7JN, UK
`100 South Atkinson Road, Suite 206, Grayslake, IL 60030-7820, USA
`
`and the American Pharmacists Association
`2215 Constitution Avenue, NW, Washington, DC 20037-2985, USA
`
`© Pharmaceutical Press and American Pharmacists Association 2006
`
`(PP) is a trademark of Pharmaceutical Press
`
`First published 1986
`Second edition published 1994
`Third edition published 2000
`Fourth edition published 2003
`Fifth edition published 2006
`
`Printed in Great Britain by Butler & Tanner, Frome, Somerset
`Typeset by Data Standards Ltd, Frome, Somerset
`
`ISBN 0 85369 618 7 (UK)
`ISBN 1 58212 058 7 (USA)
`
`All rights reserved. No part of this publication may be
`reproduced, stored in a retrieval system, or transmitted in any
`form or by any means, without the prior written permission
`of the copyright holder.
`The publisher makes no representation, express or implied,
`with regard to the accuracy of the information contained in
`this book and cannot accept any legal responsibility or
`liability for any errors or omissions that may be made.
`
`A catalogue record for this book is available from the British Library
`
`Library of Congress Cataloging-in-Publication Data
`Handbook of pharmaceutical excipients.-5th ed. / edited by Raymond C.
`Rowe, Paul J. Sheskey, Sian C. Owen.
`p. ; cm.
`Includes bibliographical references and index.
`ISBN 1-58212-058-7 (USA) — ISBN 0-85369-618-7 (UK)
`1. Excipients—Handbooks, manuals, etc.
`[DNLM: 1. Excipients—Handbooks. 2. Technology, Pharmaceutical—Handbooks.
`QV 735 H236 2006] I. Rowe, Raymond C. II. Sheskey, Paul J. III. Owen, Sian C.
`IV. American Pharmacists Association.
`
`RS201.E87H36 2006
`615'.19—dc22
`
`2005028523
`
`Mylan Ex 1045, Page 2
`
`

`

`Ph© phi e, Dibasic
`
`8 Description
`The USP 28 states that dibasic sodium phosphate is dried or
`contains, 1, 2, 7, or 12 molecules of water of hydration.
`Anhydrous dibasic sodium phosphate occurs as a white
`powder. The dihydrate occurs as white or almost white,
`odorless crystals. The heptahydrate occurs as colorless crystals
`or as a white granular or caked salt that effloresces in warm,
`dry air. The dodecahydrate occurs as strongly efflorescent,
`colorless or transparent crystals.
`
`9 (cid:9) Pharmacopeia! Specifications
`See Table I.
`
`Table I: (cid:9)
`dibasicM.
`
`Test
`
`Pharmacopeial specifications for sodium phosphate,
`
`JP 2001 (cid:9)
`
`PhEur 2005 USP 28
`
`9.0-9.4
`
`0.014%
`
`0.4%
`
`40.06%
`
`0.025
`
`,..200 ppm
`..400 ppm
`--<_200 ppm
`
`0.2%
`
`16 ppm
`
`40.002%
`
`19- .5-21.0%
`
`5.0%
`10.3-12.0%
`18.5-21.5%
`43.0-50.0%
`55.0-64.0%
`98.0-101.0% 98.0-100.5%
`
`1 (cid:9) Nonproprietary Names
`BP: (cid:9)
`Anhydrous disodium hydrogen phosphate
`Disodium hydrogen phosphate
`Disodium hydrogen phosphate dodecahydrate
`JP: (cid:9)
`Dibasic sodium phosphate
`PhEur: Dinatrii phosphas anhydricus
`Dinatrii phosphas dihydricus
`Dinatrii phosphas dodecahydricus
`USP: (cid:9)
`Dibdsic sodium phosphate
`Note that the BP 2004 and PhEur 2005 contain three separate
`monographs for the anhydrous, the dihydrate, and the
`dodecahydrate; the JP 2001 contains one monograph for the
`dodecahydrate; and the USP 28 contains one monograph for
`the anhydrous, the monohydrate, the dihydrate, the heptahy-
`drate, and the dodecahydrate. See also Section 8.
`
`2 Synonyms
`Disodium hydrogen phosphate; disodium phosphate; E339;
`phosphoric acid, disodium salt; secondary sodium phosphate;
`sodium orthophosphate.
`
`3 (cid:9) Chemical Name and CAS Registry Number
`Anhydrous dibasic sodium phosphate [7558-79-4]
`Dibasic sodium phosphate dihydrate [10028-24-7]
`Dibasic sodium phosphate dodecahydrate [10039-32-4]
`Dibasic sodium phosphate heptahydrate [7782-85-6]
`Dibasic sodium phosphate hydrate [10140-65-5]
`Dibasic sodium phosphate monohydrate [118830-14-1]
`
`4 (cid:9) Empirical Formula and Molecular Weight
`Na2HPO4
`141.96
`Na2HPO4.H20
`159.94
`Na2HPO4-2H20
`177.98
`Na2HPO4.7H20
`268.03
`Na2HPO4.12H20
`358.08
`
`5 (cid:9) Structural Formula
`Na2HPO4•xH2O where x = 0, 1, 2, 7, or 12.
`
`6 (cid:9) Functional Category
`Buffering agent; sequestering agent.
`
`7 Applications in Pharmaceutical Formulation
`or Technology
`Dibasic sodium phosphate is used in a wide variety of
`pharmaceutical formulations as a buffering agent and as a
`sequestering agent. Therapeutically, dibasic sodium phosphate
`is used as a mild laxative and in the treatment of hypopho-
`sphatemia.(1'2)
`Dibasic sodium phosphate is also used in food products; for
`example as an emulsifier in processed cheese.
`
`Identification
`Characters
`Appearance of solution
`pH
`Reducing substances
`Insoluble substances
`Monosodium phosphate
`Carbonate
`Chloride
`Anhydrous
`Dihydrate
`Dodecahydrate
`Water
`Anhydrous
`Dihydrate
`Dodecahydrate
`Sulfates
`Anhydrous
`Dihydrate
`Dodecahydrate
`Arsenic
`Anhydrous
`Dihydrate
`Dodecahydrate
`Heavy metals
`Anhydrous
`Dihydrate
`Dodecahydrate
`Iron
`Anhydrous
`Dihydrate
`Dodecahydrate
`Loss on drying
`Anhydrous
`Monohydrate
`Dihydrate
`Heptahydrate
`Dodecahydrate
`Assay (dried basis)
`98.0%
`{°) PhEur 2005 (Suppl. 5.1) for the dodecahydrate.
`
`57.0-61.0%
`0.038% +
`500 ppm
`+0.1%
`...500 ppm
`
`—
`
`-<,- 2 ppm
`
`ppm
`LiPPrn
`-<,2 ppm
`
`,<J0ppm
`
`—
`—
`
`-.10ppm
`ppm
`-<..10ppm
`+
`‹,20 ppm
`-<_40 ppm
`20 ppm
`57- .0-61.0% +
`
`Mylan Ex 1045, Page 3
`
`(cid:9)
`(cid:9)
`

`

`694 (cid:9)
`
`Sodium Phosphate, Dibasic
`
`Typical Properties
`10 (cid:9)
`Acidity/alkalinity: pH = 9.1 for a 1% w/v aqueous solution of
`the anhydrous material at 25°C. A saturated aqueous
`solution of the dodecahydrate has a pH of about 9.5.
`Ionization constants:
`pKai = 2.15 at 25°C;(3)
`pKa2 = 7.20 at 25°C;
`pKa3 = 12.38 at 25°C.
`Moisture content: the anhydrous form is hygroscopic and will
`absorb water on exposure to air, whereas the heptahydrate
`is stable in air.
`Osmolarity: a 2.23% w/v aqueous solution of the dihydrate is
`isoosmotic with serum; a 4.45% w/v aqueous solution of the
`dodecahydrate is isoosmotic with serum.
`Solubility: very soluble in water, more so in hot or boiling
`water; practically insoluble in ethanol (95%). The an-
`hydrous material is soluble 1 in 8 parts of water, the
`heptahydrate 1 in 4 parts of water, and the dodecahydrate 1
`in 3 parts of water.
`
`Stability and Storage Conditions
`11 (cid:9)
`The anhydrous form of dibasic sodium phosphate is hygro-
`scopic. When heated to 40°C, the dodecahydrate fuses; at
`100°C it loses its water of crystallization; and at a dull-red heat
`(about 240°C) it is converted into the pyrophosphate,
`Na4P2O7. Aqueous solutions of dibasic sodium phosphate are
`stable and may be sterilized by autoclaving.
`The bulk material should be stored in an airtight container,
`in a cool, dry place.
`
`12 Incompatibilities
`Dibasic sodium phosphate is incompatible with alkaloids,
`antipyrine, chloral hydrate, lead acetate, pyrogallol, resorcinol
`and calcium gluconate, and ciprofloxacin.(4) Interaction
`between calcium and phosphate, leading to the formation of
`insoluble calcium—phosphate precipitates, is possible in par-
`enteral admixtures.
`
`13 (cid:9) Method of Manufacture
`Either bone phosphate (bone ash), obtained by heating bones to
`whiteness, or the mineral phosphorite is used as a source of
`tribasic calcium phosphate, which is the starting material in the
`industrial production of dibasic sodium phosphate.
`Tribasic calcium phosphate is finely ground and digested
`with sulfuric acid. This mixture is then leached with hot water
`and neutralized with sodium carbonate, and dibasic sodium
`phosphate is crystallized from the filtrate.
`
`14 Safety
`Dibasic sodium phosphate is widely used as an excipient in
`parenteral, oral, and topical pharmaceutical formulations.
`Phosphate occurs extensively in the body and is involved in
`many physiological processes since it is the principal anion of
`intracellular fluid. Most foods contain adequate amounts of
`phosphate, making hypophosphatemia (phosphate defi-
`ciency)(1) virtually unknown except for certain disease states(2)
`or in patients receiving total parenteral nutrition. Treatment is
`usually by the oral administration of up to 100 mmol of
`phosphate daily.
`
`Approximately two-thirds of ingested phosphate is
`absorbed from the gastrointestinal tract, virtually all of it being
`excreted in the urine, and the remainder is excreted in the feces.
`Excessive administration of phosphate, particularly intra-
`venously, rectally, or in patients with renal failure, can cause
`hyperphosphatemia that may lead to hypocalcemia or other
`severe electrolyte imbalances.(5'6) Adverse effects occur less
`frequently following oral consumption, although phosphates
`act as mild saline laxatives when administered orally or rectally.
`Consequently, gastrointestinal disturbances including diarrhea,
`nausea, and vomiting may occur following the use of dibasic
`sodium phosphate as an excipient in oral formulations.
`However, the level of dibasic sodium phosphate used as an
`excipient in a pharmaceutical formulation is not usually
`associated with adverse effects.
`LD50 (rat, oral): 17 g/kg(7)
`
`15 (cid:9) Handling Precautions
`Observe normal precautions appropriate to the circumstances
`and quantity of material handled. Dibasic sodium phosphate
`may be irritating to the skin, eyes, and mucous membranes. Eye
`protection and gloves are recommended.
`
`16 (cid:9) Regulatory Status
`GRAS listed. Accepted in Europe for use as a food additive.
`Included in the FDA Inactive Ingredients Guide (injections;
`infusions; nasal, ophthalmic, oral, otic, topical, and vaginal
`preparations). Included in nonparenteral and parenteral
`medicines licensed in the UK. Included in the Canadian List
`of Acceptable Non-medicinal Ingredients.
`
`17 (cid:9) Related Substances
`Dibasic potassium phosphate; sodium phosphate, monobasic;
`tribasic sodium phosphate.
`
`Dibasic potassium phosphate
`Empirical formula: K2HPO4
`Molecular weight: 174.15
`CAS number: [7758-11-4]
`Synonyms: dipotassium hydrogen orthophosphate; dipotas-
`sium hydrogen phosphate; dipotassium phosphate; E340;
`potassium phosphate.
`Appearance: colorless or white, granular, hygroscopic powder.
`Acidity/alkalinity: pH = 8.5-9.6 for a 5% w/v aqueous solution
`at 25°C.
`Osmolarity: a 2.08% w/v aqueous solution of dibasic
`potassium phosphate is isoosmotic with serum.
`Solubility: freely soluble in water; very slightly soluble in
`ethanol (95%).
`Comments: one gram of dibasic potassium phosphate contains
`approximately 11.5 mmol of potassium and 5.7 mmol of
`phosphate.
`
`Tribasic sodium phosphate
`Empirical formula: Na3PO4•xH2O
`Molecular weight: 163.94 for the anhydrous material
`380.06 for the dodecahydrate (12H20)
`CAS number: [7601-54-9] for the anhydrous material.
`
`Mylan Ex 1045, Page 4
`
`

`

`Synonyms: E339; trisodium orthophosphate; trisodium phos-
`phate; TSP.
`Acidity/alkalinity: pH = 12.1 for a 1% w/v aqueous solution of
`the anhydrous material at 25°C. A 1% w/v aqueous solution
`of the dodecahydrate at 25°C has a pH of 12.0-12.2.
`Density:
`1.3 g/cm' for the anhydrous material;
`0.9 g/cm3 for the dodecahydrate.
`Solubility: the anhydrous material is soluble 1 in 8 parts of
`water, while the dodecahydrate is soluble 1 in 5 parts of
`water at 20°C.
`
`18 Comments
`One gram of anhydrous dibasic sodium phosphate represents
`approximately 14.1 mmol of sodium and 7.0 mmol of phos-
`phate.
`One gram of dibasic sodium phosphate dihydrate represents
`approximately 11.2 mmol of sodium and 5.6 mmol of phos-
`phate.
`One gram of dibasic sodium phosphate heptahydrate
`represents approximately 7.5 mmol of sodium and 3.7 mmol
`of phosphate.
`One gram of dibasic sodium phosphate dodecahydrate
`represents approximately 5.6 mmol of sodium and 2.8 mmol of
`phosphate.
`A specification for sodium phosphate, dibasic is contained in
`the Food Chemicals Codex (FCC).
`
`Sodium Phosphate, Dibasic (cid:9)
`
`695
`
`19 (cid:9) Specific References
`1 (cid:9) Lloyd CW, Johnson CE. Management of hypophosphatemia. Clin
`Pharm 1988; 7: 123-128.
`2 Holland PC, Wilkinson AR, Diez J, Lindsell DRM. Prenatal
`deficiency of phosphate, phosphate supplementation, and rickets
`in very-low-birthweight infants. Lancet 1990; 335: 697-701.
`3 (cid:9) Albert A, Serjearnt EP. Ionization Constants of Acids and Bases,
`2nd edn. Edinburgh: Chapman and Hall, 1971.
`4 Benjamin BE. Ciprofloxacin and sodium phosphates not compa-
`tible during actual Y-site injection [letter]. Am J Health Syst Pharm
`1996; 53: 1850-1851.
`5 Haskell LP. Hypocalcaemic tetany induced by hypertonic-phos-
`phate enema [letter]. Lancet 1985; ii: 1433.
`6 Martin RR, Lisehora GR, Braxton M, Barcia PJ. Fatal poisoning
`from sodium phosphate enema: case report and experimental
`study. J Am Med Assoc 1987; 257: 2190-2192.
`7 (cid:9) Lewis RJ, ed. Sax's Dangerous Properties of Industrial Materials,
`11th edn. New York: Wiley, 2004: 3273.
`
`20 General References
`Sweetman SC, ed. Martindale: The Complete Drug Reference, 34th
`edn, London: Pharmaceutical Press, 2005: 1231.
`
`21 Authors
`AS Kearney.
`
`22 (cid:9) Date of Revision
`20 August 2005.
`
`Mylan Ex 1045, Page 5
`
`

`

`Sodium Phosphate, Monobasic
`
`1 (cid:9) Nonproprietary Names
`BP: (cid:9)
`Anhydrous sodium dihydrogen phosphate
`Sodium dihydrogen phosphate monohydrate
`Sodium dihydrogen phosphate dihydrate
`PhEur: Natrii dihydrogenophosphas dihydricus
`USP: (cid:9)
`Monobasic sodium phosphate
`Note that the BP 2004 contains three separate monographs for
`the anhydrous, the monohydrate, and the dihydrate; the PhEur
`2005 contains a single monograph for the dihydrate; and the
`USP 28 contains one monograph for the anhydrous, the
`monohydrate and the dihydrate. See also Section 8.
`
`2 Synonyms
`Acid sodium phosphate; E339; Kalipol 32; monosodium
`orthophosphate; monosodium phosphate; phosphoric acid,
`monosodium salt; primary sodium phosphate; sodium biphos-
`phate; sodium dihydrogen orthophosphate; sodium dihydrogen
`phosphate.
`
`3 (cid:9) Chemical Name and CAS Registry Number
`Anhydrous monobasic sodium phosphate [7558-80-7]
`Monobasic sodium phosphate monohydrate [10049-21-5]
`Monobasic sodium phosphate dihydrate [13472-35-0]
`
`4 (cid:9) Empirical Formula and Molecular Weight
`NaH2PO4 (cid:9)
`119.98
`NaH2PO4.1-120 (cid:9)
`137.99
`NaH2PO4•2H20 156.01
`
`5 (cid:9) Structural Formula
`NaH2PO4.xH20 where x = 0, 1, or 2.
`
`The hydrated forms of monobasic sodium phosphate occur
`as odorless, colorless or white, slightly deliquescent crystals.
`The anhydrous form occurs as a white crystalline powder or
`granules.
`
`9 (cid:9) Pharmacopeia! Specifications
`See Table I.
`
`Table I: (cid:9)
`Pharmacopeial specifications for sodium phosphate,
`monobasic.
`
`Test
`
`PhEur 2005 (cid:9)
`
`USP 28
`
`Identification
`Characters
`Appearance of solution
`Aluminum, calcium and related
`elements
`Arsenic
`Chloride
`Insoluble substances
`Heavy metals
`Insoluble substances
`Iron
`Organic volatile impurities
`pH
`Reducing substances
`Sulfate
`Water
`Anhydrous
`Monohydrate
`Dihydrate
`Assay (dried basis)
`
`(2 ppm
`200 ppm
`
`8 ppm
`i‹,.0.014%
`
`ppm
`
`ppm
`
`0.2%
`
`4.- 2-4.5
`
`4.1-4.5
`
`--<_300 ppm
`
`21- .5-24.0%
`98.0-100.5%
`
`10.0-15.0%
`18.0-26.5%
`98.0-103.0%
`
`Functional Category
`6 (cid:9)
`Buffering agent; emulsifying agent; sequestering agent.
`
`7 Applications in Pharmaceutical Formulation
`or Technology
`Monobasic sodium phosphate is used in a wide variety of
`pharmaceutical formulations as a buffering agent and as a
`sequestering agent. Therapeutically, monobasic sodium phos-
`phate is used as a mild saline laxative and in the treatment of
`hypophosphatemia.(1-3)
`Monobasic sodium phosphate is also used in food products,
`for example, in baking powders, and as a dry acidulant and
`sequestrant.
`
`8 Description
`The USP 28 states that monobasic sodium phosphate contains
`one or two molecules of water of hydration or is anhydrous.
`
`Typical Properties
`10 (cid:9)
`Acidity/alkalinity: pH = 4.1-4.5 for a 5% w/v aqueous solution
`of the monohydrate at 25°C.
`Density: 1.915 g/cm3 for the dihydrate.
`Dissociation constant: pKa = 2.15 at 25°C
`Solubility: soluble 1 in 1 of water; very slightly soluble in
`ethanol (95%).
`
`Stability and Storage Conditions
`11 (cid:9)
`Monobasic sodium phosphate is chemically stable, although it
`is slightly deliquescent. On heating at 100°C, the dihydrate
`loses all of its water of crystallization. On further heating, it
`melts with decomposition at 205°C, forming sodium hydrogen
`pyrophosphate, Na2H2P2O7. At 250°C it leaves a final residue
`of sodium metaphosphate, NaPO3.
`Aqueous solutions are stable and may be sterilized by
`autoclaving.
`Monobasic sodium phosphate should be stored in an
`airtight container in a cool, dry place.
`
`Mylan Ex 1045, Page 6
`
`

`

`12 Incompatibilities
`Monobasic sodium phosphate is an acid salt and is therefore
`generally incompatible with alkaline materials and carbonates;
`aqueous solutions of monobasic sodium phosphate are acidic
`and will cause carbonates to effervesce.
`Monobasic sodium phosphate should not be administered
`concomitantly with aluminum, calcium, or magnesium salts
`since they bind phosphate and could impair its absorption from
`the gastrointestinal tract. Interaction between calcium and
`phosphate, leading to the formation of insoluble calcium
`phosphate precipitates, is possible in parenteral admix-
`tures.(4-6)
`
`13 (cid:9) Method of Manufacture
`Monobasic sodium phosphate is prepared by adding phospho-
`ric acid to a hot, concentrated solution of disodium phosphate
`until the liquid ceases to form a precipitate with barium
`chloride. This solution is then concentrated and the monobasic
`sodium phosphate is crystallized.
`
`14 Safety
`Monobasic sodium phosphate is widely used as an excipient in
`parenteral, oral, and topical pharmaceutical formulations.
`Phosphate occurs extensively in the body and is involved in
`many physiological processes since it is the principal anion of
`intracellular fluid. Most foods contain adequate amounts of
`phosphate, making hypophosphatemia(1) virtually unknown
`except for in certain disease states(2) or in patients receiving
`total parenteral nutrition. Treatment is usually by the oral
`administration of up to 100 mmol of phosphate daily.
`Approximately two-thirds of ingested phosphate is
`absorbed from the gastrointestinal tract, virtually all of it being
`excreted in the urine, and the remainder is excreted in the feces.
`Excessive administration of phosphate, particularly intra-
`venously, rectally, or in patients with renal failure, can cause
`hyperphosphatemia that may lead to hypocalcemia or other
`severe electrolyte imbalances.(7-9) Adverse effects occur less
`frequently following oral consumption, although phosphates
`act as mild saline laxatives when administered orally or rectally
`(2-4 g of monobasic sodium phosphate in an aqueous solution
`is used as a laxative). Consequently, gastrointestinal distur-
`bances including diarrhea, nausea, and vomiting may occur
`following the use of monobasic sodium phosphate as an
`excipient in oral formulations. However, the level of monobasic
`sodium phosphate used as an excipient in a pharmaceutical
`formulation is not usually associated with adverse effects.
`LD50 (rat, IM): 0.25 g/kg(10)
`LD50 (rat, oral): 8.29 g/kg
`
`15 Handling Precautions
`Observe normal precautions appropriate to the circumstances
`and quantity of material handled. Monobasic sodium phos-
`phate may be irritant to the skin, eyes, and mucous membranes.
`Eye protection and gloves are recommended.
`
`16 (cid:9) Regulatory Status
`GRAS listed. Accepted for use as a food additive in Europe.
`Included in the FDA Inactive Ingredients Guide (injections;
`infusions; ophthalmic, oral, topical, and vaginal preparations).
`Included in nonparenteral and parenteral medicines licensed in
`
`Sodium Phosphate, Monobasic (cid:9)
`
`697
`
`the UK. Included in the Canadian List of Acceptable Non-
`medicinal Ingredients.
`
`17 (cid:9) Related Substances
`Dibasic sodium phosphate; monobasic potassium phosphate.
`
`Monobasic potassium phosphate
`Empirical formula: KH2PO4
`Molecular weight: 136.09
`CAS number: [7778-77-0]
`Synonyms: E340; monopotassium phosphate; potassium acid
`phosphate; potassium biphosphate; potassium dihydrogen
`orthophosphate.
`Appearance: colorless crystals or a white, odorless, granular or
`crystalline powder.
`Acidity/alkalinity: pH P-14.5 for a 1% w/v aqueous solution at
`25°C.
`Solubility: freely soluble in water; practically insoluble in
`ethanol (95%).
`Comments: 1 g of monobasic potassium phosphate represents
`approximately 7.3 mmol of potassium and of phosphate.
`The EINECS number for monobasic potassium phos-
`phate is 231-913-4.
`
`18 Comments
`One gram of anhydrous monobasic sodium phosphate
`represents approximately 8.3 mmol of sodium and of phos-
`phate.
`One gram of monobasic sodium phosphate monohydrate
`represents approximately 7.2 mmol of sodium and of phos-
`phate.
`One gram of monobasic sodium phosphate dihydrate
`represents approximately 6.4 mmol of sodium and of phos-
`phate.
`A specification for sodium phosphate monobasic is con-
`tained in the Food Chemicals Codex (FCC). The EINECS
`number for monobasic sodium phosphate is 231-449-2.
`
`19 (cid:9) Specific References
`1 Lloyd CW, Johnson CE. Management of hypophosphatemia. Clin
`Pharm 1988; 7: 123-128.
`2 Holland PC, Wilkinson AR, Diez J, Lindsell DRM. Prenatal
`deficiency of phosphate, phosphate supplementation, and rickets
`in very-low-birthweight infants. Lancet 1990; 335: 697-701.
`3 Rosen GH, Boullata JI, O'Rangers EA, et al. Intravenous
`phosphate repletion regimen for critically ill patients with
`moderate hypophosphatemia. Crit Care Med 1995; 23: 1204-
`1210.
`4 Eggert LD, Rusho WJ, Mackay MW, Chan GM. Calcium and
`phosphorus compatibility in parenteral nutrition solutions for
`neonates. Am J Hosp Pharm 1982; 39: 49-53.
`5 Niemiec PW, Vanderveen TW. Compatibility considerations in
`parenteral nutrient solutions. Am J Hosp Pharm 1984; 41: 893-
`911.
`6 Pereira-da-Silva L, Nurmamodo A, Amaral JM, et al. Compat-
`ibility of calcium and phosphate in four parenteral nutrition
`solutions for preterm neonates. Am J Health Syst Pharm 2003; 60:
`1041-1044.
`7 Haskell LP. Hypocalcaemic tetany induced by hypertonic-
`phosphate enema [letter]. Lancet 1985; 1433.
`8 (cid:9) Larson JE, Swigart SA, Angle CR. Laxative phosphate poisoning:
`pharmacokinetics of serum phosphorus. Hum Toxicol 1986; 5:
`45-49.
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`698 (cid:9)
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`Sodium Phosphate, Monobasic
`
`9 Martin RR, Lisehora GR, Braxton M, Barcia PJ. Fatal poisoning
`from sodium phosphate enema: case report and experimental
`study. J Am Med Assoc 1987; 257: 2190-2192.
`10 (cid:9) Lewis RJ, ed. Sax's Dangerous Properties of Industrial Materials,
`11th edn. New York: Wiley, 2004: 3274.
`
`21 Authors
`LY Galichet.
`
`20 (cid:9) General References
`Sweetman SC, ed. Martindale: The Complete Drug Reference, 34th
`edn. London: Pharmaceutical Press, 2005: 1230.
`
`22 (cid:9) Date of Revision
`17 August 2005.
`
`1'
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