U. S. PHARMACOPEIA
`
`NATIONAL FORMULARY
`
`SUPPLEMENT
`
`PAGES 4125-4481
`
`Official
`May 15, 1998
`
`•
`
` n 71 new monographs
`• New general tests chapter-^<823>; '; ;;•
`: Radiopharmaceuticals for Positrorij :;
`;
`. , . Emission Tomography—Compounding;
`^^4^ater for Injection and Purified Water^
`(^Requirements for Total Organic Carbon
`R<643> and Water Conductivity <645>
`> New general information chapter^- : ^
`<1116> Microbiological Evaluation; " ^
`of Clean Rooms and Other
`T . Controlled Environments
`
`, Title changes to become official ; •
`May 15, 1998
`. ; (and others on November 15,1998) ; ;
`: for several injectable dosage forms
`
`: Revisions of <11> USP Reference;^ ^ ^
`Standards-^Up-to-date cumulative list ; ^
`and label text
`
`IMPORTANTl
`Save Supplement 1 and
`all succeeding Supplements
`
`PROPERTY OF
`COVINGTON & BURLING
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`112464
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`[
`
`USP 23
`
`Supplement 8
`
`NF 18
`
`The United States
`Pharmacopeia
`
`The National
`Formulary
`
`TWENTY-THIRD REVISION
`EIGHTEENTH EDITION
`By authority of the United States Pharmacopeial Convention, Inc.
`Prepared by the Committee of Revision and published by the Board of Trustees
`
`SINCE 1 820
`
`Jordan L. Cohen, Chairman
`USPC Board of Trustees
`
`Jerome A. Halperin, Executive Vice President
`and Chainnan. USP Committee of Revision
`
`Lee T. Grady, Vice President and Director
`Division of Standards Development
`
`Official May 15, 1998, except where otherwise noted.
`
`Released March 15, 1998.
`
`Notice
`
`The texts of the United States Phaimacopeia and the National Formulary are fully copyrighted.
`Authors and others wishing to use portions of the text should request permission to do so from the
`Secretary of the USPC Board of Trustees, 12601 Twinbrook Parkway, Rockville, Marshland 20852.
`
`This Supplement comprises revisions and new text pertaining to both USP 23 and NF 18, and entries arc listed
`in general in the order in which they occur in the respective compendia. Important—Save the First Supplement
`and all succeeding Supplements. Changes and additions listed iri the Eighth Supplement are effective from May
`15, 1998, except where otherwise noted.
`
`Supplement
`
`IRA''
`
`1st
`
`2nd
`
`3rd
`
`4th
`
`5th
`
`6th
`
`7th
`
`8th
`
`1st, PF 20(6)
`2nd. PF2\{\)
`.3rd. PF21(2)
`
`4th. PF2\0)
`.5th. PF2\W
`6th. PF 2\{5)
`
`7th. PF 21(6)
`8th, PF 22(1)
`9th, PF 22(2)
`
`lOth, PF 22(3)
`llth. PF 22(3)
`12th. PF 22(4)
`i.3ih. PF 22(5)
`
`14th. PF 22(6)
`t.5ih, PF 23(1)
`I6th. PF 23(2)
`
`I7ih. PF 23(3)
`18th. PF 2.3(4)
`19th. PF 2.3(5)
`
`20th. PF 23(6)
`21sl. PF 24(1)
`
`Release Date
`
`Nov. 1. 1994
`Dec. 10. 1994
`Jan. 10. 1995
`Mar. 10. 1995
`Mar. 15. 1995
`May 10. 1995
`July 10. 1995
`Sept. 10. 1995
`Sept. 15. 1995
`Nov. 10, 1995
`Jan. 10. 1996
`Mar. 10. 1996
`Mar. 15, 1996
`May 10. 1996
`Apr. 22. 1996
`July 10. 1996
`Sept. 10. 1996
`Sept. 15. 1996
`Nov. 10. 1996
`Jan. 10. 1997
`Mar. 10. 1997
`Mar. 1.5. 1997
`May 10. 1997
`July 10, 1997
`Sept. 10, 1997
`Sept. 15. 1997
`Nov. 10. 1997
`Jan. 10. 1998
`Mar. 15. 1998
`
`Official Date
`
`Jan. 1. 1995
`Jan. 1. 1995
`Feb. 1. 1995
`Apr. 1. 1995
`May 15. 1995
`June 1. 1995
`Aug. i. 1995
`Oct. 1, 1995
`Nov. 15, 1995
`Dec. 1. 1995
`Feb. 1, 1996
`Apr. 1. 1996
`May 15. 1996
`June 1. 1996
`May 15. 1996
`Aug. 1. 1996
`Get, 1, 1996
`Nov. 15. 1996
`Dec. 1, 1996
`Feb. 1. 1997
`Apr. 1. 1997
`May 15, 1997
`June 1, 1997
`Aug. 1. 1997
`Oct. 1. 1997
`Nov. 15. 1997
`Dec. 1. 1997
`Feb. 1. 1998
`May 15, 1998
`
`Entirely
`Superseded h\
`
`2S
`2S
`.3S
`
`—
`
`.3S
`.35
`4S
`
`—
`
`4S
`4S
`5S
`
`—
`
`5S
`5S
`5S
`6S
`
`—
`
`6S
`6S
`7S
`
`—
`
`7S
`7S
`8S
`
`—
`
`8S
`8S
`
`—
`
`* Interim Revision Annonnccments (IRAs) are published a.s needed in Plutrniucopeuil Forum ;uid are incorporated into the
`ne.xt succeeding Supplement. This column shows the Vol. and No. of the issue of PI- in which each IRA appe;u-ed,
`
`All inquiries and comments regarding USP 23 text and NF IS text should be addressed to the Division of Standards
`Development, U.S. Fhannacopcia, 12601 Twinbrook Parkway, Rockville. MD 20852.
`
`^5 1998 The United Slates Pharmacopeial Convention. Inc. 12601 Twinbrook Parkway, Rockville, MD 20852
`ISSN 0195-7996
`All righis re.-ien-ed.
`
`Mylan v. Qualicaps, IPR2017-00203
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`

`

`r
`
`People
`
`Contents
`
`Officers of the Convention
`Board of Trustees
`General Committee of Revision
`Executive Committee of Revision
`USP Nomenclature Committee
`Division of Standards Development Executive Committee
`and Subcommittees
`USP Reference Standards Committee
`USP-FDA Joint Committee on Bioequivalence
`USP-FDA Antibiotic Monograph Subcommittee
`Division of Standards Development Panels
`
`- a uT—
`List 0\ CtAangeS ano
`Notices
`
`New Monographs Appearing in This supplement
`Admissions
`. igA V Changes in Official Titles Appearing in This Supplement
`» General Notices, Monographs, General Chapters, Reagents,
`A Additions ' and Tables Affected by changes Appearing
`i„ This supplement
`.'Introduction
`USP 23 General Notices and Requirements
`
`Monographs, USP Official Monographs for USP 23
`
`General
`
`General Tests and Assays
`General Information
`
`Redgents
`
`Reagents, Indicators, and Solutions
`
`Tables
`
`Description and Relative Solubility of USP and NF Articles
`
`NF
`
`Index
`
`NF 18 General Notices and Requirements
`Official Monographs for NF 18
`
`Changes to Combined Index to USP 23 and NF 18
`Cumulative Index to Seventh Supplement
`
`4126
`4126
`4126
`4128
`4128
`
`4128
`4129
`4129
`4129
`4129
`
`4131
`4131
`
`4133
`4140
`4143
`
`4151
`
`4281
`4334
`
`4441
`
`4445
`
`4447
`4443
`
`4457
`4458
`
`I
`
`Moving ?
`
`Our subscribers' records and publication labels are computer-generated for
`efficient service. When you change your address and give us 30-days notice
`together with a recent address label, you assure our mailing to the proper
`address. Please send your new address and your latest label, or an exact
`copy of it, to; USPC, Customer Service Dept., P.O. Box 560 Wiiiiston
`VT 05495-0560.
`
`4125
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`

`People
`United States Pharmacopeial Convention
`
`¤
`
`: i
`
`Officers
`(1995-2000)
`Jane E. Henney, M.D.
`President
`Albuquerque. NM
`John T. Fay, Jr., Ph.D.
`Treasurer
`San Clemente, CA
`Mark Novitch, M.D.
`Past President
`Washington, DC
`Jerome A. Halperin
`Secretary
`Rockville. MD
`
`Board of Trustees
`(1995-2000)
`Jordan L. Cohen, Ph.D.'
`Chair
`Lexington. KY
`Edwin D. Bransome, Jr., M.D.^
`Augusta, GA
`William H. Campbell, Ph.D.'
`Chapel Hill. NC
`John T. Fay, Jr., Ph.D.
`ex officio
`San Clemente. CA
`Jean Paul Gagnon, Ph.D.^
`Kansas City, MO
`Jane E. Henney, M.D.
`ex officio
`Albuquerque, NM
`Edward L. Langston, R.Ph., M.D.^
`Rock Island, IL
`Joseph A. Mollica, Ph.D.^
`Princeton, NJ
`
`Grace Powers Monaco, J.D."*
`Burgess, VA
`
`' Representing pharmacy.
`^ At large.
`Representing medicine.
`•" Public member.
`' 12601 Twinbrook Parkway, Rockville.
`MD 20852.
`^ Deceased.
`
`4126
`
`Mark Novitch, M.D,
`ex officio
`Washington. DC
`
`Edward Zalta, M.D.^
`Newport Beach, CA
`
`General Committee
`of Revision
`1995-2000
`Jerome A. Halperin,
`Executive Vice President, USPC
`12601 Twinbrook Parkway '
`Rockville, MD 20852
`Chair
`Lee T. Grady, Ph.D.^
`Vice President and Director
`of Standards Development
`Keith W. Johnson'
`Vice President and Director
`of Information Development
`Loyd V. Allen, Jr., Ph.D.
`Oklahoma City, OK
`Jerry R. Allison, Ph.D.« (I995)
`New Brunswick, NJ
`Thomas J. Ambrosio, Ph.D.
`Kenilworth, NJ
`Ann B. Amerson, Pharm.D.
`Lexington, KY
`Gordon L. Amldon, Ph.D.
`Ann Arbor, MI
`Gregory E. Amldon, Ph.D.
`Kalamazoo, MI
`Henry L. Avallone
`Titusville, NJ
`Larry L. Augsburger, Ph.D.
`Baltimore, MD
`Leonard C. Bailey. Ph.D.
`Piscataway, NJ
`Jorge R. Barrio, Ph.D.
`Los Angeles, CA
`Gregory B. Bennett, Ph.D. M R a
`East Hanover, NJ
`^
`Terrence F. Blaschke, M.D.
`Stanford, CA
`Judy P. Boehlert, Ph.D.
`Park Ridge, NJ
`James C. Boylan, Ph.D.
`Abbott Park, IL
`R, Edward Branson, Ph.D.
`Brookville, MD
`
`William H. Briner, Capt.
`Durham, NC
`Harry G. Brittain, Ph.D.
`Maplewood, NJ
`Paul M. Bummer, Ph.D. R.Ph.
`Lexington, KY
`Stephen R. Byrn, Ph.D.
`West Lafayette, IN
`Peter R. Byron, Ph.D.
`Richmond, VA
`
`Ronald J. Callahan, Ph.D.
`Boston, MA
`
`Herbert S. Carlin, D.Sc.
`Califon, NJ
`Culley C. Carson, M.D.
`Chapel Hill, NC
`Lester Chafetz, Ph.D.
`Kansas City, MO
`Vie W. Chien, Ph.D.
`Piscataway, NJ
`Henry M. Chilton, Pharm.D.
`Winston-Salem, NC
`
`Zak T. Chowhan, Ph.D.
`Hunt Valley, MD
`Sebastian G. Ciancio, D.D.S.
`Buffalo, NY
`Patricia E. Cole, Ph.D., M.D.
`Stony Brook, NY
`David S. Cooper, M.D.
`Baltimore, MD
`Murray S. Cooper. Ph.D.
`Islamorada, PL
`William A. Craig, M.D.
`Madison, WI
`Stephanie Y. Crawford, Ph.D.
`Chicago, IL
`Edward M. Croom, Ph.D.
`University, MS
`Ian E. Davidson, Ph.D., M.B.A.
`Kansas City, MO
`Leon Ellenbogen, Ph.D.
`Wayne, NJ
`Hans Fisher, Ph.D.
`New Brunswick, NJ
`Edward A. Fitzgerald, Ph.D.
`Rockville, MD
`Everett Flanlgan, Ph.D.
`Kankakee, IL
`Thomas S. Foster, Pharm.D.
`Lexington, KY
`C. David Fox, Ph.D.
`Rouses Point, NY
`Sylvan G. Frank, Ph.D.
`Columbus, OH
`
`• : I
`
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`
`

`

`Eighth Supplement USP-NF
`
`People / Revision Committee
`
`4127
`
`David O. Freedman, M.D.
`Birmingham, AL
`Joseph F. Gallelli, Ph.D.
`Bethesda, MD
`Barry D. Garhnkle, Ph.D.
`West Point, PA
`Robert L. Garnick, Ph.D.
`So. San Francisco, CA
`
`John Christian Gillin, M.D.
`San Diego, CA
`Douglas D. Glover, R.Ph., M.D.
`Morgantown, WV
`Alan M. Goldberg, Ph.D.
`Baltimore, MD
`Dennis K.J. Gorecki, Ph.D.
`Saskatoon, Saskatchewan, CANADA
`Robert M. Guthrie, M.D.
`Columbus, OH
`Samir A. Hanna, Ph.D.
`Lawrenceville, NJ
`Stanley L. Hem, Ph.D.
`West Lafayette, IN
`Evelyn V. Hess, M.D., F.A.C.P.,
`M.A.C.R.
`Cincinnati, OH
`Joy Hochstadt, Ph.D.
`New York. NY
`Richard D. Johnson, Ph.D., Pharm. D.
`Kansas City, MO
`H. Thomas Karnes, Ph.D.
`Richmond, VA
`David B. Katague, Ph.D.
`Rockville, MD
`Rosalyn C. King, Pharm.D., M.P.H.
`Silver Spring, MD
`Gordon L. Klein, M.D., M.P.H.
`Galveston, TX
`Harvey G. Klein, M.D.
`Bethesda, MD
`Joseph E. Knapp, Ph.D.
`Pittsburgh. PA
`Michael S. Korczynski, Ph.D.
`Baltimore, MD
`Helen F. Krause, M.D.
`Pittsburgh, PA
`Paul Kucera, Ph.D.
`Pearl River, NY
`Pauline M. Lacroix, M.S.
`Ottawa, Ontario, CANADA
`Vernon C. Langston, D.V.M., Ph.D.
`Mississippi State, MS
`Thomas P. LayloiT, Ph.D.
`St. Louis, MO
`Patricia D. Leinbach, Ph.D.
`Rockville, MD
`John W. Levchuk, Ph.D.
`Rockville, MD
`Robert D. Lindeman, M.D.
`Albuquerque, NM
`Charles H. Lochmiiller, Ph.D.
`Durham, NC
`Hugh E. Lockhart, Ph.D.
`East Lansing, MI
`Edward G. Lovering, Ph.D.
`Nepean, Ontario, CANADA
`Catherine M. MacLeod, M.D.
`
`Chicago, IL
`Carol S. Marcus, Ph.D., M.D.
`Torrance. CA
`Joan C. May, Ph.D.
`Rockville. MD
`Michael Mayersohn, Ph.D.
`Tucson, AZ
`Keith M. McErlane, Ph.D.
`Vancouver, BC, CANADA
`Thomas Medwick, Ph.D.
`Piscataway, NJ
`Robert F. Morrissey, Ph.D.
`New Brunswick, NJ
`Terry E. Munson
`Fairfax, VA
`Steven L. Nail, Ph.D.
`West Lafayette, IN
`Harold S. Nelson, M.D.
`Denver, CO
`David W. Newton, Ph.D.
`Winchester, VA
`Sharon J. Northup, Ph.D., M.B.A.
`Deerfield, IL
`Samuel W. Page, Ph.D.
`Washington, DC
`Garnet E. Peck, Ph.D.
`West Lafayette, IN
`Robert V. Petersen, Ph.D.
`Salt Lake City, UT
`Rosemary C. Polomano, Ph.D., M.S.N.,
`R.N.
`Philadelphia, PA
`Ronald E. Reid, Ph.D.
`Vancouver. BC, CANADA
`Thomas P. Reinders, Pharm.D.
`Richmond, VA
`Christopher T. Rhodes, Ph.D.
`Kingston, RI
`Jim E. Riviere, D.V.M., Ph.D.
`Raleigh, NC
`George A. Robertson, Ph.D.
`Frederick, MD
`Joseph R. Robinson, Ph.D.
`Madison, WI
`Lary A. Robinson, M.D.
`Tampa, FL
`Harold N. Rode, Ph.D.
`Ottawa, Ontario, CANADA
`Dan M. Roden, M.D.
`Nashville, TN
`David B. Roll, Ph.D.
`Salt Lake City, UT
`Thomas W. Rosanske, Ph.D.
`Kansas City, MO
`Theodore J. Roseman, Ph.D.
`Round Lake, IL
`
`Peter C. Ruenitz, Ph.D.
`Athens, OA
`Sally S. Seaver, Ph.D.
`Concord, MA
`Gordon D. SchifT, M.D.
`Chicago, IL
`Paul L. Schiff, Jr., Ph.D.
`Pittsburgh, PA
`Ralph F. Shangraw, Ph.D.
`Baltimore, MD
`
`EH Shefter, Ph.D.
`La Jolla, CA
`
`Eric B. Sheinin, Ph.D.
`Rockville, MD
`Robert L. Siegle, M.D.
`San Antonio, TX
`Edward B. Silberstein, M.D.
`Cincinnati, OH
`Marilyn Dix Smith, Ph.D.
`Princeton, NJ
`
`Emil J. Staba, Ph.D.
`Minneapolis, MN
`Thomas E. Starzl, M.D., Ph.D.
`Pittsburgh, PA
`Robert S. Stern, M.D.
`Boston, MA
`James T. Stewart, Ph.D.
`Athens, GA
`Scott V. W. Sutton, Ph.D.
`Fort Wonh, TX
`
`Dennis P. Swanson. M.S.
`Pittsburgh, PA
`Henry S. I. Tan. Ph.D.
`Cincinnati, OH
`Thomas D. Thomson, Ph.D., V.M.D.
`Greenfield, IN
`Clarence T. Ueda, Pharm.D., Ph.D.
`Omaha, NE
`Huib J.M. van de Donk, Ph.D.
`Bilthoven, The Netherlands
`Stanley van den Noort, M.D.
`Irvine, CA
`Joseph C. Veltri, Pharm.D.
`Salt Lake City, UT
`Robert E. Vestal, M.D.
`Boise, ID
`Irving W. Wainer, Ph.D.
`Washington, DC
`Philip D. Walson, M.D.
`Columbus, OH
`
`Elliott T. Weisman
`Philadelphia, PA
`Paul F. White, Ph.D., M.D.
`Dallas, TX
`Richard J. Whitley, M.D.
`Birmingham, AL
`Robert G. Wolfangel, Ph.D.
`St. Louis, MO
`Manfred E. Wolff, Ph.D.
`Laguna Beach, CA
`Marie Linda A. Workman, Ph.D., R.N.
`Cleveland, OH
`Wesley E. Workman, Ph.D.
`St. Louis, MO
`Timothy J. Wozniak, Ph.D.
`Indianapolis, IN
`Dale Eric Wurster, Ph.D.
`Iowa City, lA
`John W. Yarbro, M.D., Ph.D.
`Springfield, IL
`Lynn C. Yeoman, Ph.D.
`Houston, TX
`Thom J. Zimmerman, M.D., Ph.D.
`Louisville, KY
`
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`
`

`

`4128
`
`Revision Committee / Peop/e
`
`Eighth Supplement, USP-NF
`
`Executive Committee of Revision
`Jerome A. Halperin, Chair
`Lester Chafelz. Ph.D.; Joseph F. Gallelli, Ph.D.; Gordon L.
`Klein, M.D.. M.P.H.; Robert D. Lindeman, M.D.; Carol S.
`Marcus, Ph.D., M.D.; Joseph R. Robinson, Ph.D.
`
`USP Nomenclature Committee
`Herbert S. Carmn, D.Sc., Chair
`William M. Heller, Ph.D., Consultant/Advisor
`Ann B. Amerson, Pharm.D.; Lester Chafelz, Ph.D.; Stephanie
`Y. Crawford, Ph.D.; Everett Ranigan, Ph.D.; Douglas D.
`Glover, R.Ph., M.D.; Richard D. Johnson, Ph.D., Pharm.D.;
`Edward G. Lovering, Ph.D.; Rosemary C. Polomano, Ph.D.,
`M.S.N., R.N.; Thomas P. Reinders, Pharm.D.; Eric B. Sheinin,
`Ph.D.; Thomas D. Thomson, Ph.D., V.M.D.; Philip D. Walson,
`M.D.
`
`Division of Standards Development
`Executive Committee
`Thomas P. Layloff, Ph.D., Chair
`Gregory E. Amidon, Ph.D.; Judy P. Boehlert, Ph.D.; James C.
`Boylan, Ph.D.; William H. Briner, Capt.; Herbert S. Carlin,
`D.Sc.; Zak T. Chowhan, Ph.D.; Everett Ranigan, Ph.D.; Thomas
`S. Foster, Pharm.D.; Robert L. Gamick, Ph.D.; Dennis K. J.
`Gorecki, Ph.D.; Stanley L. Hem, Ph.D.; Joseph E. Knapp, Ph.D.;
`Paul Kucera, Ph.D.; Thomas P. Layloff, Ph.D.; Edward G.
`Lovering, Ph.D.; Thomas Medwick, Ph.D.; Sharon J. Northup,
`Ph.D., M.B.A.; Ralph F. Shangraw, Ph.D.; James T. Stewart,
`Ph.D.; Henry S. I. Tan, Ph.D.; Elliott T. Weisman
`
`CH2. Subcommittee on Chemistry 2
`Dennis K. J. Gorecki, Ph.D., Chair
`Gregory B. Bennett, Ph.D., M.B.A.; Lester Chafetz, Ph.D.; H.
`Thomas Kames, Ph.D.; Charles H. Lochmiiller, Ph.D.; Eli Shef-
`ter, Ph.D.; Marilyn Dix Smith, Ph.D.
`
`•'V i
`
`CH3. Subcommittee on Chemistry 3
`Judy P. Boehlert, Ph.D., Chair
`Stephen R. Bym, Ph.D.; Ian E. Davidson, Ph.D., M.B.A.; Tho
`mas P. Layloff, Ph.D.; Keith M. McErlane, Ph.D.; Peter C. Ruen-
`itz, Ph.D.; Irving W. Wainer, Ph.D.
`
`CH4. Subcommittee on Chemistry 4
`Elliott T. Weisman, Chair
`Harry G. Brittain, Ph.D.; Pauline M. Lacroix, M.S.; Thomas W.
`Rosanske, Ph.D.; Eric B. Sheinin, Ph.D.; Timothy J. Wozniak,
`Ph.D.
`
`CH5. Subcommittee on Chemistry 5
`Edward G. Lovering, Ph.D., Chair
`Leonard C. Bailey, Ph.D.; Peter R. Byron, Ph.D.; Charles H.
`Lochmiiller, Ph.D.; James T. Stewart, Ph.D.; Robert G. Wolf-
`angel, Ph.D.; Manfred E. Wolff, Ph.D.; Wesley E. Workman,
`Ph.D.
`
`DBA. Subcommittee on Dissolution and Bioavailability
`Thomas S. Foster, Pharm.D., Chair
`Gordon L. Amidon, Ph.D.; Stephen R. Bym, Ph.D.; Michael
`Mayersohn, Ph.D.: Christopher T. Rhodes, Ph.D.; Joseph R. Rob
`inson, Ph.D.; Thomas W. Rosanske, Ph.D.; Theodore J. Rose-
`man, Ph.D.; Eli Shefter, Ph.D.; Clarence T. Ueda, Pharm.D.,
`Ph.D.
`
`EXl. Subcommittee on Excipients—Monographs
`Zak T. Chowhan, Ph.D., Chair
`Larry L. Augsburger, Ph.D.; Peter R. Byron, Ph.D.; C. David
`Fox, Ph.D.; Sylvan G. Frank, Ph.D.; Joan C. May, Ph.D.; Garnet
`E. Peck, Ph.D.: Ralph F. Shangraw, Ph.D.
`
`• > i
`
`Division of Standards Development
`Subcommittees
`
`ANT. Subcommittee on Antibiotics
`Henry S. i. Tan, Ph.D., Chair
`Samir A. Hanna, Ph.D.; David B. Kalague, Ph.D.; Paul Kucera,
`Ph.D.; Keith M. McErlane, Ph.D.; Jim E. Riviere, D.V.M., Ph.D.;
`Eli Shefter, Ph.D.; Eric B. Sheinin, Ph.D.; Thomas D. Thomson,
`Ph.D., V.M.D.
`
`BBV. Subcommittee on Biopolymers, Bioproducts,
`and Vaccines
`
`Everett Flanigan, Ph.D., Chair
`Vie W. Chicn, Ph.D.; Murray S. Copper, Ph.D.; Barry D. Gar-
`finkle, Ph.D.; George A. Robertson, Ph.D.; Huib J.M. van de
`Donk, Ph.D.; Richard J. Whitley, M.D.; Manfred E. Wolff, Ph.D.
`
`BGT. Subcommittee on Biotechnology and Gene Therapy
`Robert L. Garnick, Ph.D., Chair
`R. Edward Branson, Ph.D.; Paul M. Bummer, Ph.D., R.Ph.; Pa
`tricia E, Cole, Ph.D., M.D.; Joseph F. Gallelli, Ph.D.; Harold N.
`Rode, Ph.D.; Sally S. Seaver, Ph.D.; Wesley E. Workman, Ph.D.;
`Lynn C. Yeoman, Ph.D.
`
`EX2. Subcommittee on Excipients—^Methods
`Gregory E. Amidon, Ph.D., Chair
`Larry L. Augsburger, Ph.D.; Harry G. Brittain, Ph.D.; Stephen
`R. Bym, Ph.D.; C. David Fox. Ph.D.; Gamet E. Peck, Ph.D.;
`Dale E. Wurster, Ph.D.
`
`GEN. Subcommittee on General Chapters
`Thomas P. Layloff, Ph.D., Chair
`Judy P. Boehlert, Ph.D.; Irving W. Wainer, Ph.D.
`
`MCB. Subcommittee on Microbiology
`Joseph E. Knapp, Ph.D., Chair
`Henry L. Avallone; Murray S. Cooper, Ph.D.; Edward A. Fitz
`gerald, Ph.D.; Barry D. Garfinkle, Ph.D.; Michael S. Korczynski,
`Ph.D.; John W. Levchuk, Ph.D.; Robert F. Morrissey, Ph.D.;
`Terry E. Munson; Steven L. Nail, Ph.D.; Scott V. W. Sulton,
`Ph.D.; Huib J.M. van de Donk, Ph.D.
`
`MPI. Subcommittee on Multisource Products Issues
`James T. Stewart, Ph.D., Chair
`
`NAT. Subcommittee on Natural Products
`Paul Kucera, Ph.D., Chair
`Edward M. Croom, Ph.D.; David B. Katague, Ph.D.; Edward G.
`Lovering, Ph.D.; Samuel W. Page, Ph.D.; Paul L. Schiff, Jr.,
`Ph.D.; E. John Slaba, Ph.D.
`
`CHI. Subcommittee on Chemistry 1
`Stanley L. Hem, Ph.D., Chair
`Loyd V. Allen, Jr., Ph.D.; H. Thomas Karnes, Ph.D.; Patricia D.
`Leinbach, Ph.D.; Joan C. May, Ph.D.; Thomas Medwick, Ph.D.;
`Thomas D. Thomson, Ph.D., V.M.D.
`
`NDN. Subcommittee on Nonprescription Drugs and Nutri
`tional Supplements
`Ralph F. Shangraw, Ph.D., Chair
`Leon Ellenbogen. Ph.D.; Hans Fisher, Ph.D.; Dennis K. J. Go
`recki, Ph.D.; Edward G. Lovering, Ph.D.; David B. Roll, Ph.D.
`
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`

`Eighth Supplement, USP-NF
`
`People / Panels
`
`4129
`
`PSD. Subcommittee on Packaging, Storage, and Distribution
`Thomas Medwick, Ph.D., Chair
`Loyd V. Allen, Jr., Ph.D.; Thomas J. Ambrcsio, Ph.D.; Larry L.
`Augsburger, Ph.D.; Leonard C. Bailey, Ph.D.; Zak T. Chowhan,
`Ph.D.; Hugh E. Lockhart, Ph.D.; David W. Newton, Ph.D.; Chris
`topher T. Rhodes, Ph.D.
`
`RAD. Subcommittee on Radiopharmaceuticals
`William H. Briner, Capt., Chair
`Jorge R. Barrio, Ph.D.; Ronald J. Callahan. Ph.D.; Henry M.
`Chilion, Pharm.D.; Edward B. Silberstein, M.D.; Dennis P.
`Swanson, M.S.
`
`TBC. Subcommittee on Toxicity, Biocompatibility, and Cell
`Culture
`Sharon J. Northup, Ph.D., M.B.A., Chair
`Thomas J. Ambrosio, Ph.D.; Alan M. Goldberg, Ph.D.; Joy
`Hochstadt, Ph.D.; Robert V. Petersen, Ph.D.; Ronald E. Reid,
`Ph.D.; Peter C. Ruenilz, Ph.D.; Marie Linda A. Workman, Ph.D.,
`R.N.
`
`W&P. Subcommittee on Water and Parenterals
`James C. Boylan, Ph.D., Chair
`Henry L. Avallone; Joseph F. Gallelli, Ph.D.; John W. Levchuk,
`Ph.D.; Terry E. Munson; Steven L. Nail, Ph.D.; David W. New
`ton, Ph.D.; Theodore J. Roseman, Ph.D.; Marie Linda A. Work
`man, Ph.D.; R.N.
`
`USP Reference Standards
`Committee
`Lee T. Grady, Ph.D., Chair, ex ojficio
`Judy P. Boehlert, Ph.D.; Zak T. Chowhan, Ph.D.; Everett Flan-
`igan, Ph.D.; Stanley L. Hem, Ph.D.; Thomas P, Layloff, Ph.D.;
`Edward G. Levering, Ph.D.; Sharon J. Northup, Ph.D.
`
`#
`
`USP-FDA Joint Committee
`on Bioequivalence
`Robert A. Rippere, Chair
`
`Representing FDA, Rockville, MD;
`Ramakant M. Mhatre, Ph.D.; Larry A. Ouderkirk; Robert A.
`Rippere
`
`Representing USP, Rockville, MD:
`Thomas S. Foster, Pharm.D.; Lee T. Grady, Ph.D.; Barbara B.
`Hubert; Lewis J. Leeson, Ph.D.
`
`USP-FDA Antibiotic Monograph
`Subcommittee
`
`William W. Wright, Ph.D., Chair
`
`%
`
`Representing FDA, Rockville. MD:
`Peter Dionne; Katharine A. Freeman; James M. Timper, Jr.,
`M.S.; Robert A. Rippere
`
`Representing USP, Rockville, MD:
`Roger Dabbah, Ph.D.; Lee T. Grady, Ph.D.; William W. Wright,
`Ph.D.
`
`Division of Standards Development
`Panels
`
`Advisory Panel on Analytical Methods for Nonprescription
`Drugs and Nutritional Supplements
`Ralph F. Shangraw, Ph.D., Chair, Baltimore MD; Norman W.
`Atwater, Ph.D., Columbus, NJ; David M. Baaske, Ph.D., Balti
`more, MD; Frederick Bangert, Morrisville, NC; Ofelia Barretto,
`Buena Park, CA; Ira Berry, Union, NJ; Hemi Bhagwan, Ph.D.,
`Nutley, NJ; Arthur D. Bond, Ph.D., Richmond, VA; Joy Joseph,
`San Fernando, CA; Marilyn Langley, Greenville, SC; Michael J.
`Lebelle, Ottawa, Ontario, Canada; Herbert Letterman, Ph.D.,
`New Providence, NJ; Jeffery L. Otto, Ph.D., Arvada, CO; Walter
`A. Schuize, Carson, CA; Michael Smela, Jr., Rockville, MD;
`Paula Jo Meyer Stout, Ph.D., Morgantown, WV; Margaret A.
`Targove, Ph.D., Princeton, NJ; William VanMeter, Allegan, MI;
`George L. Walker, Memphis, TN
`Advisory Panel on Compendial Items: Storage, Shipment, and
`Distribution
`Leonard C. Bailey, Ph.D., Chair, Piscataway, NJ; Anthony Car-
`fagno, Bethlehem, PA; Clyde R. Erskine, Newton Square, PA;
`Herbert Letterman, Ph.D., New Providence, NJ.
`Advisory Panel on Gene and Cell Therapies
`Sally S. Seaver, Ph.D., Chair, Concord, MA; Patricia E. Cole,
`Ph.D., M.D., Smithtown, NY; Steward Craig, Ph.D., Baltimore,
`MD; Gary C. DuMoulin, Ph.D., Cambridge, MA; Joyce D. Fran
`cis, Ph.D., Gaithersburg, MD; Joseph F. Gallelli, Ph.D., Be-
`thesda, MD; Robert L. Gamick, Ph.D., So. San Francisco, CA;
`Richard D. Huhn, M.D., Bethesda, MD; Beth Hutchins, Ph.D.,
`San Diego, CA; Ann Jakubowski, Ph.D., M.D., New York, NY;
`Andra Miller, Ph.D., Rockville, MD; Elizabeth J. Read, M.D.,
`Bethesda, MD; Nancy C. Sajjadi, San Diego, CA; William E.
`Tente, Lincoln, RI; Joyce Frey Vasconcells, Ph.D., Rockville,
`MD
`Advisory Panel on Identification and Standardization of Natu
`ral Products
`Paul L. Schiff, Jr., Ph.D., Chair, Pittsburgh, PA; Dennis V.C.
`Awang, Ph.D., Ottawa, Ontario, Canada; Ezio Bombardelli,
`Ph.D., Milan, Italy (1997-); Robert P. Borris, Ph.D., Rahway, NJ
`(1995-1996); Werner Busse, Ph.D., Karlsruhe, Germany (1997-);
`Horace G. Cutler, Ph.D., Atlanta, GA; Jonathan W. DeVries,
`Ph.D., Minneapolis, MN; Gary W. Elmer, Ph.D., Seattle, WA;
`Fran S. Ertl, Long Beach, CA (1996-); Patrick Hoffman, Ph.D.,
`Hunt Valley, MD; Charles D. Hufford, Ph.D., University, MS;
`Michael Ihrig, Ph.D., Eschbom, Germany; A. Douglas Kinghom,
`Ph.D., Chicago, IL; Nahid Mokhtari-Rejali, Ph.D., Rockville,
`MD; William Popin, M.S., American Fork, UT (1997-); Amala
`Raman, Ph.D., London, United Kingdom; Rory P. Remmel,
`Ph.D., Minneapolis, MN (1995-1997); Brent Roth, Park City, UT
`(1996-1997); Walter A. Schuize, Carson, CA (1996-1997); Sid
`ney J. Stohs, Ph.D., Omaha, NE
`Expert Advisory Panel on Pharmacy Compounding Practices
`Thomas Medwick, Ph.D., Chair, Piscataway, NJ; Martin Golden,
`Consultant/Coordinator, Smyrna, DE; Loyd V, Allen, Jr., Ph.D.,
`Oklahoma City, OK; Suggy Chrai, Ph.D., East Windsor, NJ;
`Mary Ann Kirkpatrick, Richmond, VA; David Liebman, Balti
`more. MD; Paul Lotbolm, Pharm.D., Kentfield, CA; James R.
`Morse, Tucson, AZ; J. Graham Nairn, Ph.D., Toronto, Ontario,
`Canada; David W. Newton, Ph.D., Winchester, VA; Evelyn D.
`Timmons, Paradise Valley, AZ
`Advisory Panel on Microbiological Control and Process
`Validation
`Joseph E, Knapp, Ph.D., Chair, Pittsburgh, PA; James E. Akers,
`Ph.D.. Kansas City, MO; Michael J. Akers, Ph.D., Indianapolis,
`IN; Wei-Wei Chang, Ph.D., Canton, MA; Richard Levy, Ph.D.,
`Bedford, MA; Tibor Matula, Ph.D., Ottawa, Ontario, Canada;
`T.C. Soli, Ph.D., Greenville, NC; Marlys E. Weary, Mount Pros
`pect, IL
`Advisory Panel on Multisource Products
`James T. Stewart, Ph.D., Chair, Athens, GA; Edward M. Cohen,
`Ph.D., Carmel, NY; Peter Jeffs, Ottawa, Ontario, Canada; Lewis
`
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`4130
`
`Panels / People
`
`Eighth Supplement, USP-NF
`
`J. Leeson, Ph.D., Montville, NJ: Jeffery L. Otto, Ph.D., Arvada,
`CO; Sidney J. Smith, Ph.D., Markham, Ontario, Canada; V. Sub-
`ramanian, Ph.D., Northvale, NJ; Alice Till, Ph.D., Washington,
`DC; Vincent S. Venturella, Ph.D., Cedar Grove, NJ
`Advisory Panel on Pharmacy Compounding General Chapter
`Mary Ann Kirkpatrick, Chair, Richmond, VA; Martin Golden,
`Consuliant/Coordinaior, Smyrna, DE; Suggy Chrai, Ph.D., East
`Windsor, NJ; Paul Lofholm, Pharm.D., Kenfield, CA; David W.
`Newton, Ph.D., Winchester, VA; Evelyn D. Timmons, Paradise
`Valley, AZ
`Review Panel on Pharmacy Compounding Practices
`Thomas Medwick, Ph.D., Chair, Piscataway, NJ; Martin Golden.
`R.Ph. Consultant/Coordinator, Smyrna, DE; John W. Andrews,
`Winston Salem, NC; Daniel J. Jacob, Tucson, AZ; Nicholas G.
`Lordi, Ph.D., Piscataway, NJ; Timothy D. Moore, Columbus,
`OH; R. T. Moss, Jr., Florence, SC; Glynn G. Raymond, Ph.D..
`Albuquerque, NM; James A. Rogers, Ph.D.. Edmonton, Alberta,
`Canada; Howard L. Stark, Kansas City, MO; Judith E. Thomp
`son,. M.S., Madison, WI
`
`Advisory Panel on Physical Test Methods—Functionality
`Gregory E. Amidon, Ph.D., Chair, Kalamazoo, MI; Michael S.
`Bergren, Ph.D., Kalamazoo, MI; Harry G. Brittain, Ph.D., Murray
`Hill, NJ; David J.W. Grant, D.Phil., Minneapolis, MN; Keith
`Marshall, Ph.D., Brick, NJ; Shigeru Itai, Ph.D., Ohmiya-shi, Sai-
`tama, Japan; Hans Leuenberger, Ph.D., Basel, Switzerland
`
`Advisory Panel on Polymeric Excipients
`Garnet E. Peck, Ph.D., Chair, West Lafayette, IN; Tim D. Ca-
`belka, Ph.D., Midland, Ml; George Chen, Ph.D., Rockville, MD;
`Bruno Hancock, Ph.D., Point-Claire-Dorval, Quebec, Canada;
`James McGinity, Ph.D., Austin, TX; Kinam Park, Ph.D., West
`Lafayette, NJ; Stuart Porter, Ph.D., West Point, PA; Thomas A.
`Wheatley, Princeton, NJ; Richard Fengl, Ph.D., Kingsport, TN
`
`Review Panel on Spanish Translation of USP Text
`Solomon Stavchansky, Ph.D., Chair, Austin. TX; Aquiles Ar-
`ancibia, Ph.D., Santiago, Chile; Enrique Fefer, Ph.D., Washing
`ton, DC; Regina Pezoa, Ph.D., Santiago, Chile; Marcelo Ver-
`nengo, Ph.D., Buenos Aires, Argentina
`
`0)
`
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`

`Admissions
`
`New Monographs Appearing in This Supplement
`
`USP 23
`
`Acyclovir Ointment
`Alfentanil Hydrochloride
`Alfenlanii Injection
`Aminophylline Delayed-release Tablets
`Bacitracin for Injection
`Bisacodyl Rectal Suspension
`Bisacodyl Delayed-release Tablets
`Calcium Acetate Tablets
`Cefamandole Nafate
`Cefmenoxime Hydrochloride
`Cefonicid Sodium
`Cefonicid for Injection
`Ccfoperazone Injection
`Cefoperazone for Injection
`Cefotaxime for Injection
`Cefotiam Hydrochloride
`Ceftizoxime Injection
`Ceftizoxime for Injection
`Ceftriaxone Injection
`Ceftriaxone for Injection
`Cefuroxime Injection
`Cefuroxime for Injection
`Cephalothin Injection
`Cephalothin for Injection
`Cephapirin Sodium
`Cephapirin for Injection
`Clarithromycin for Oral Suspension
`Cyclosporine Injection
`Dimethyl Sulfoxide Gel
`Dimethyl Sulfoxide Topical Solution
`Doxycycline for Injection
`Enalapril Maleate and Hydrochlorothiazide Tablets
`Eucalyptol
`
`Guaifenesin for Injection
`Indium In III Satumomab Pendetide Injection
`Isradipine
`Lactase
`Menthol Lozenges
`Methenamine Mandelate Delayed-release Tablets
`Mitoxantrone Injection
`Moricizine Hydrochloride
`Moricizine Hydrochloride Tablets
`Naftifine Hydrochloride
`Naftifine Hydrochloride Cream
`Naftifine Hydrochloride Gel
`Neomycin for Injection
`Poloxalene
`Polympin B for Injection
`Potassium Iodide Delayed-release Tablets
`Quazepam
`Quazepam Tablets
`Sargramostim
`Sargramostim for Injection
`Sulfamethoxazole and Trimethoprim Injection
`Sulfaquinoxaline Oral Solution
`Sulfasalazine Delayed-release Tablets
`Trenbolone Acetate
`Trifiuridine
`Tylosin
`Tylosin Granulated
`Vidarabine
`Zidovudine
`Zidovudine Capsules
`Zidovudine Injection
`Zidovudine Oral Solution
`
`NF 18
`
`Garlic
`Powdered Garlic
`Methacrylic Acid Copolymer Dispersion
`
`Valerian
`Powdered Valerian
`
`4131
`
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`

`4132
`
`Changes / Admissions
`
`Eighth Supplement, USP-NF
`
`Changes in Official Titles Appearing in This Supplement
`
`The following title changes are official May 15, 1998;
`
`USP 23 New Title
`
`Cefmenoxime Hydrochloride
`Cefonicid Sodium
`Cefonicid for Injection
`Cefoperazone Sodium
`Cefoperazone Injection
`Cefoperazone for Injection
`Cefotaxime Sodium
`Cefotaxime Injection
`Cefotaxime for Injection
`Cefoliam Hydrochloride
`Cefotiam for Injection
`Ceftizoxime Sodium
`Ceflizoxime Injection
`Ceftizoxime for Injection
`Ceftriaxone Sodium
`Ceftriaxone Injection
`Ceftriaxone for Injection
`Cefuroxime Sodium
`Cefuroxime Injection
`Cefuroxime for Injection
`Cephaiothin Sodium
`Cephalothin Injection
`Caphalothin for Injection
`Cephapirin Sodium
`Cephapirin for Injection
`Cephradine
`Cephradine for Injection
`Speclinomycin Hydrochloride
`
`USP 23 Former Title
`
`Sterile Cefmenoxime Hydrochloride
`Sterile Cefonicid Sodium
`Sterile Cefonicid Sodium
`Sterile Cefoperazone Sodium
`Cefoperazone Sodium Injection
`Sterile Cefoperazone Sodium
`Sterile Cefotaxime Sodium
`Cefotaxime Sodium Injection
`Sterile Cefotaxime Sodium
`Sterile Cefotiam Hydrochloride
`Sterile Cefotiam Hydrochloride
`Sterile Ceftizoxime Sodium
`Ceftizoxime Sodium Injection
`Sterile Ceftizoxime Sodium
`Sterile Ceftriaxone Sodium
`Ceftriaxone Sodium Injection
`Sterile Ceftriaxone Sodium
`Sterile Cefuroxime Sodium
`Cefuroxime Sodium Injection
`Sterile Cefuroxime Sodium
`Sterile Cephalothin Sodium
`Cephalothin Sodium Injection
`Cephalothin Sodium for Injection
`Sterile Cephapirin Sodium
`Sterile Cephapirin Sodium
`Sterile Cephradine
`Sterile Cephradine
`Sterile Spectinomycin Hydrochloride
`
`The following title changes are official May 15, 1999:
`
`USP 23 New Title
`
`Bisacodyl Delayed-release Tablets
`Cyclosporine Injection
`Mitoxantrone Injection
`Sulfamethoxazole and Trimethoprim Injection
`Vidarabine
`
`USP 23 Former Title
`
`Bisacodyl Tablets
`Cyclosporine Concentrate for Injection
`Mitoxantrone for Injection Concentrate
`Sulfamethoxazole and Trimethoprim for Injection Concentrate
`Sterile Vidarabine
`
`The following title changes are official January 1, 2000:
`
`• #
`
`USP 23 New Title
`
`Bacitracin
`Bacitracin for Injection
`Bacitracin Zinc
`Ccfamandole Nafate
`Cefamandole Nafate for Injection
`Chlortetracycline Hydrochloride
`Cloxacillin Benzathine
`Cloxacillin Sodium
`Doxycycline Hyclate
`Doxycycline for Injection
`Neomycin Sulfate
`Neomycin for Injection
`Polymyxin B Sulfate
`Polymyxin B For Injection
`
`USP 23 Former Title
`
`Sterile Bacitracin
`Sterile Bacitracin
`Sterile Bacitracin Zinc
`Sterile Cefamandole Nafate
`Sterile Cefamandole Nafate
`Sterile Chlortetracycline Hydrochloride
`Sterile Cloxacillin Benzathine
`Sterile Cloxacillin Sodium
`Sterile Doxycycline Hyclate
`Doxycycline Hyclate for Injection
`Sterile Neomycin Sulfate
`Sterile Neomycin Sulfate
`Sterile Polymyxin B Sulfate
`Sterile Polymyxin B Sulfate
`
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`

`i
`
`f
`
`ANNOTATED LIST
`
`General Notices, Monographs, General Chapters, Reagents, and Tables
`Affected by Changes Appearing in This Supplement
`Page citations refer to the pages of this Supplement. Note—The absence of a parenthetic term after the section
`heading denotes a change in the text, as distinguished from a newly added or deleted section.
`
`General Notices and Requirements
`Tests and Assays, 4143
`Foreign Substances and Impurities
`Preservation. Packaging, Storage, and Labeling, 4147
`Storage under Nonspecific Conditions
`Labeling
`
`Monographs (USP 23)
`Acetaminophen and Aspirin Tablets, 4151
`Dissolution
`Acetaminophen, Aspirin, and Caffeine Capsules, 4151
`Dissolution
`Acetaminophen and Caffeine Capsules, 4152
`Dissolution
`Acetaminophen and Codeine Phosphate Capsules, 4152
`Dissolution
`c.
`Acetaminophen and Diphenhydramine Citrate Tablets, 4152
`Dissolution
`Acetohydroxamic Acid Tablets, 4153
`Dissolution
`Acyclovir Ointment (new), 4153
`Dehydrated Alcohol, 4153
`Ultraviolet absorbance
`Alfentanil Hydrochloride (new), 4153
`Alfentanil Injection (new), 4154
`Alprazolam Tablets, 4155
`Dissolution
`Amantadine Hydrochloride Capsules, 4155
`Dissolution
`Amcinonide, 4155
`AiS'ay
`Amcinonide Cream, 4156
`Assay
`Amcinonide Ointment, 4156
`Assay
`Amikacin Sulfate Injection, 4156
`Identification (test A)
`Aminophyiline Injection, 4157
`USP Reference standards
`Assay
`Aminophyiline Tablets, 4157
`Disintegration (deleted)
`Aminophyiline Delayed-release Tablets (new), 4157
`Aminosalicylate Sodium Tablets, 4157
`Dissolution
`Amphetamine Sulfate Tablets, 4157
`Dissolution
`Ampicillin Capsules, 4157
`Dissolution
`Ampicillin Tablets, 4158
`Dissolution
`Amprolium Oral Solution, 4158
`Assay
`Ascorbic Acid Tablets, 4158
`Dissolution
`
`Aspirin, Caffeine, and Dihydrocodeine Bitartrate Capsules, 4158
`Dissolution
`Atenolol Injection, 4159
`Bacterial endotoxins
`Bacitracin, 4159
`Labeling
`USP Reference standards
`Other requirements (added)
`Bacitracin for Injection (new), 4159
`Sterile Bacitracin, 4160
`Title change
`Bacitracin Zinc, 4160
`Labeling
`Sterility (added)
`Sterile Bacitracin Zinc, 4160