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`CIP2135
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
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`© Copyright 1986, 1994 by the American Pharmaceutical Association, 2215 Constitution Avenue NW, Washington,
`DC 20037—2985, USA, and The Pharmaceutical Press, Royal Pharmaceutical Society of Great Britain, 1 Lambeth High
`Street, London, SE1 7JN, England.
`
`A catalogue record for this book is available from the British Library.
`
`Library of Congress Catalog Card Number: 94e79492.
`
`International Standard Book Number (ISBN) in the UK: 0 85369 305 6
`International Standard Book Number (ISBN) in the USA: 0 91730 66 8
`
`No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical,
`including photocopy, recording, or any information storage or retrieval system, Without prior written permission from
`the joint publishers.
`
`Typeset in Great Britain by Alden Multimedia, Northampton.
`Printed and bound in Great Britain by
`
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`

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`154 Dextrose
`
`
`
`Continued
`
`Dextrose
`
`1. Nonproprietary Names
`BP: Glucose
`
`PhEur: Dextrosum (glucosum) monohydricum
`USP: Dextrose
`
`2. Synonyms
`Blood sugar; Caridex; corn sugar; D-(+)-glucopyranose
`monohydrate; grape sugar; starch sugar; Tabfirte D—IOO.
`
`3. Chemical Name and CAS Registry Number
`D—( + )-Glucose monohydrate [5996-10—1]
`See also Section 18.
`
`4. Empirical Formula
`C6H1206.H20
`See also Section 18.
`
`Molecular Weight
`198.17 (for monohydrate)
`
`5. Structural Formula
`
`Anhydrous material shown.
`
`6. Functional Category
`Tablet and capsule diluent; therapeutic agent; tonicity agent;
`sweetening agent.
`
`7. Applications in Pharmaceutical Formulation or
`Technology
`Dextrose is widely used in solutions to adjust tonicity and as a
`sweetening agent. Dextrose is also used as a direct compression
`tablet diluent and binder, primarily in chewable tablets.
`Although comparable as a tablet diluent to lactose, tablets
`produced with dextrose monohydrate require more lubrica—
`tion, are less friable and have a tendency to harden.(1‘3) The
`mildly reducing properties of dextrose may be used when
`tableting to improve the stability of active materials which are
`sensitive to oxidation.
`
`Dextrose is also used therapeutically and is the preferred
`source of carbohydrate in parenteral nutrition regimens.
`
`8. Description
`Dextrose occurs as odorless, sweet—tasting, colorless crystals or
`as a white crystalline or granular powder.
`
`9. Pharmacopeial Specifications
`
`Test
`
`PhEur 1983
`
`USP XXII
`
`Identification
`Color of solution
`Specific rotation
`Acidity
`Water
`(for monohydrate)
`
`+
`+
`+52.5° to + 533°
`+
`75—95%
`
`+
`+
`+ 525° to + 535°
`+
`7.595%
`
`Test
`PhEur 1983
`USP XXII
`
`
`< 0.1%
`< 0.1%
`Residue on ignition
`< 0.018%
`< 125 ppm
`Chloride
`S 0.025%
`< 200 ppm
`Sulfate
`< 1 ppm
`s 1 ppm
`Arsenic
`—-—
`s 1 ppm
`Barium
`~
`S 200 ppm
`Calcium
`g 5 ppm
`7
`Heavy metals
`—
`g 0.5 ppm
`Lead
`+
`+
`Dextrin
`+
`+
`Soluble starch,
`and sulfites
`
`SEM: 1.
`Excipient: Dextrose anhydrous (granular)
`Manufacturer: Mallinckrodt Speciality Chemicals Co
`Lot No.: KLKZ
`Magnification: 180x
`
`
`
`10. Typical Properties
`Data for dextrose monohydrate shown, see Section 18 and
`HPE Data for dextrose anhydrous data.
`Acidity/alkalinity:
`pH = 3.5-5.5 (20% w/V aqueous solution)
`Compressibility: see HPE Data.
`Density: 1.54 g/cm3
`Flowability: see HPE Data.
`Heat ofsolution: 105.4 J/g (25.2 cal/g)
`Hygroscopicity: anhydrous dextrose absorbs significant
`amounts of moisture at 25°C and a relative humidity of
`about 85% to form the monohydrate. The monohydrate
`similarly only absorbs moisture at around 85% relative
`humidity and 25°C. See HPE Data.
`Melting point: 83°C
`Osmolarity: a 5.51% W/V aqueous solution is iso-osmotic with
`serum. However, it is not isotonic since dextrose can pass
`through the membrane of red cells and cause hemolysis.
`
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