3 Pharmacists’ Pharmacopeia Official May 1, 2009 – August 1, 2009 USP Pharmacists’ Pharmacopeia Notice and Warning Concerning U.S. Patent or Trademark Rights The inclusion in the USP Pharmacists’ Pharmacopeia of a monograph on any drug in respect to which pat- ent or trademark rights may exist shall not be deemed, and is not intended as, a grant of, or authority to exercise, any right or privilege protected by such patent or trademark. All such rights and privileges are vested in the patent or trademark owner, and no other person may exercise the same without express per- mission, authority, or license secured from such patent or trademark owner. Concerning Use of the USP Pharmacists’ Pharmacopeia Text Use of the USP Pharmacists’ Pharmacopeia is subject to the terms and conditions of the USP Pharmacists’ Pharmacopeia License Agreement. Attention is called to the fact that USP Pharmacists’ Pharmacopeia text is fully copyrighted. Authors and others wishing to use portions of the text should request permission to do so from the Legal Department of the United States Pharmacopeial Convention. Copyright © 2009 The United States Pharmacopeial Convention ISSN: 1930-2908 ISSN online: 1930-2916 © 2009 USP 12601 Twinbrook Parkway, Rockville, MD 20852 All rights reserved. S3/ii USP Pharmacists’ Pharmacopeia Contents USP Pharmacists’ Pharmacopeia Section 1— Section 8— Mission and Preface . S3/1 Dietary Supplement Monographs and General Chapters . S3/72 Section 2— General Notices and Requirements . S3/9 Section 13— Reference Tables of USP–NF . S3/76 Section 3— Drug Substance and Compounded Preparation Index . S3/130 Monographs . S3/22 Section 7— Pharmacy-Related General Chapters . S3/41 © 2009 USP S3/iii USP Pharmacists’ Pharmacopeia Introduction Background The history of the United States Pharmacopeia dates back to 1817 when Lyman Spalding, a physician, recognized the need for standardization to eliminate regional differences among names and formulations of medicines. He and ten fellow physi- cians held the first United States Pharmacopeial Convention (USPC) in the U.S. Capitol building in January 1820. That meeting resulted in the formation of a committee that compiled the first Pharmacopeia of the United States of America (USP). The equivalent of that committee still exists today as the USP Council of Experts, and the USPC still works to ensure good phar- maceutical care for all. In 1975, USPC combined the USP and another compendium, the National Formulary (NF), in a single volume, the USP–NF. In general, the USP contains standards for active drug substances and dietary ingredients, while the NF contains standards for excipients. Standards in the USP–NF apply to compounded preparations as well as to manufactured products. They are enforceable under the Federal Food, Drug, and Cosmetic Act, and may be enforceable to practitioners under state and local laws, as well. The USP Pharmacists’ Pharmacopeia The USP Pharmacists’ Pharmacopeia contains two types of text: official text and authorized text. Official text is text that is reproduced from the USP–NF. Each page of the book that contains official text is designated with a footer explaining its official status and the USP–NF revision from which it is reprinted. This text is derived from the standards-setting activities of the Council of Experts and is presented here in an easy-to-use abridged form. Official text that is reprinted in this volume maintains the same legal status as it does when published in the USP–NF. Authorized text has been developed and approved by the Council of Experts, but has not been published as official text in the USP–NF. Authorized text in this publication includes monographs published in the Food Chemicals Codex (FCC), Sixth edition; veterinary information© monographs 2009 discussing the use of medications USP and specific preparations for animals; pro- posed monographs for compounded preparations that are still available for comment and that may be included in the USP– NF in the future; authored text previously published in the Pharmacopeial Forum and other USPC publications; copyrighted text reprinted with permission; and text that is in the public domain, including laws and regulations. This text is provided for reference purposes only, to aid in the practices of pharmacy and medicine. The USP–NF and the FCC are modified through continuing revision, and the corresponding text in this volume will be updated accordingly. Because of varying publication schedules, changes to the USP–NF and FCC may not immediately appear as changes to the USP Pharmacists’ Pharmacopeia. The text as it appears in the USP–NF and FCC is determinative and should be referred to when specific questions arise. Second Edition This Second Edition of the USP Pharmacists’ Pharmacopeia is significantly revised from the 2005 publication. Section 3 has been enhanced to include new compounding monographs that are relevant to today’s contemporary practicing pharmacist. The addition of content related to veterinary practice in Section 6, including the information on compounds for veterinary use, should increase the utility of this volume for veterinary pharmacists. The addition of quality standards for food-grade substances from the FCC in Section 4 also should be useful to compounding professionals seeking ingredients of appropri- ate quality when a USP–NF standard does not exist. The compounding support information in Section 9 has been expanded, S3/iv USP Pharmacists’ Pharmacopeia and the laws and regulations in Section 11 have been updated to reflect the most recent changes by Congress and by the Drug Enforcement Administration. Acknowledgements The staff at USP would like to express their sincere gratitude to the members of all expert committees, especially the Com- pounding Pharmacy Expert Committee and the Sterile Compounding Expert Committee for their diligent and untiring efforts in the preparation of this book. Compounding Pharmacy Expert Committee Loyd V. Allen, Jr., Ph.D., Chair Judith E. Thompson, R.Ph., M.S., Vice Chair Lisa D. Ashworth, B.S., R.Ph. Robin H. Bogner, Ph.D. Gigi S. Davidson, R.Ph. Mary Ann F. Kirkpatrick, Ph.D. Mark G. Klang, R.Ph., M.S. Lawson G. Kloesel, R.Ph. Linda McElhiney, Pharm.D. Lawrence A. Trissel, B.S., R.Ph. Sterile Compounding Expert Committee David W. Newton, Ph.D., Chair Lawrence A. Trissel, B.S., R.Ph., Vice Chair Samuel C. Augustine, Pharm.D. Mary B. Baker, Pharm.D. James F. Cooper, Pharm.D. Donald J. Filibeck, Pharm.D. Larry W. Griffin, B.S. Kenneth L. Hughes, B.S. Eric S. Kastango, M.B.A. Keith H. St. John, M.S. Laura A. Thoma, Pharm.D. © 2009 USP James Wagner S3/v USP Pharmacists’ Pharmacopeia Admissions New Articles Appearing in This Supplement Section 3 rAlbumin Human Granisetron Hydrochloride Corn Syrup Lisinopril and Hydrochlorothiazide Tablets Erythorbic Acid Mirtazapine Orally Disintegrating Tablets Alfuzosin Hydrochloride Pantoprazole Sodium Bicalutamide Tablets Pantoprazole Sodium Delayed-Release Tablets Cabergoline Piperazine Adipate Cefdinir Piperazine Dihydrochloride Cefdinir Capsules Piperazine Phosphate Cefdinir for Oral Suspension Potassium Bromide Oral Solution, Veterinary Fenofibrate Capsules Propofol Injectable Emulsion Flavoxate Hydrochloride Sodium Bromide Injection, Veterinary Flavoxate Hydrochloride Tablets Sodium Bromide Oral Solution, Veterinary Formoterol Fumarate Tamsulosin Hydrochloride Foscarnet Sodium No Longer Appearing in Section 6 Potassium Bromide Oral Solution, Veterinary Sodium Bromide Oral Solution, Veterinary Sodium Bromide Injection, Veterinary Section 8 © 2009 USP Arginine Capsules Soy Isoflavones Capsules Arginine Tablets Soy Isoflavones Tablets Curcuminoids Turmeric Curcuminoids Capsules Powdered Turmeric Curcuminoids Tablets Powdered Turmeric Extract Powdered Soy Isoflavones Extract Changes in Official Titles The following title changes are official May 1, 2009 New Title Former Title 〈61〉 Microbiological Examination of Nonsterile Products: 〈61〉 Microbial Limit Tests Microbial Enumeration Tests 〈62〉 Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms 〈1111〉 Microbiological Examination of Nonsterile Products: 〈1111〉 Microbiological Attributes of Nonsterile Acceptance Criteria for Pharmaceutical Preparations and Pharmaceutical Products Substances for Pharmaceutical Use S3/vi USP Pharmacists’ Pharmacopeia Annotated List General Notices, Monographs, General Chapters, Reagents, and Tables Affected by Changes Appearing in This Supplement Note—In the material below, if a section is new or if a subsection is added to or deleted from an existing section, it is labeled as such in parentheses after the section or subsection name. Items on this list that appear without the designation “new,” “added,” or “deleted,” are items in which changes have been made to existing official text. General Notices and Requirements Betadex Chemical information General Chapters Packaging and storage General Tests and Assays USP Reference standards pH (added) OTHER TESTS AND ASSAYS Bicalutamide Tablets (new) 〈381〉 Elastomeric Closures for Injections Bupivacaine Hydrochloride Introduction Chemical information Test Procedures Cabergoline (new) PHYSICAL TESTS AND DETERMINATIONS Carbomer 934 〈621〉 Chromatography Title change Glossary of Symbols Definition Packaging and storage General Information Viscosity 〈1121〉 Nomenclature Carbomer 934P General Nomenclature Forms Title change © 2009Definition USP Packaging and storage Reference Tables Viscosity Description and Relative Solubility of USP and NF Articles